Page 1

a) Significance

i) The Opportunity

a.i.1 Target Population

Paralysis of ankle (POA) affects many people each year through ischemic brain injury

(stroke), traumatic brain injury, and neurological conditions. Stroke in particular attacks over

700,000 Americans each year and there are over 4.8 million stroke survivors in the U.S. [1].

These misfortunes usually affect one leg primarily and limit fundamental activities of daily

living (ADL) such as driving a car, walking, and self-care. Beyond functional loss, persons can

experience chronic pain and distortion in the affected limb, as well as inexorable musculoskeletal

deterioration through learned disuse [2].

In general, recovery outlook for POA is poor, and rehabilitation options are limited.

Rehabilitation is costly, constrained by time, practicality, travel distance, and is variably applied

depending on individual providers. Restoration of ankle function is particularly problematic, due

to its enormous complexity, and the higher priorities given to AFOs, and compensatory strategies

learned for ADL that may inhibit recovery. As a result, persons with POA are unlikely to recover

much functionality. For example, a study of stroke patients entering rehabilitation with non-

functional arms revealed that …. .

Neglecting the ankle is counterproductive, since disuse patterns and associated pathology

commence soon after immobilization of limbs. Although it is not known exactly how soon

movement attempts should begin, no evidence contraindicates commencement within a few days

of the event, at least at a minimal level. Moreover, much evidence supports the value of specific

exercises to maintain integrity of the musculoskeletal system as well as the brain sensorimotor

regions [3-23]. At least some functionality can be restored through intensive physical therapy

involving repetitive exercising, both passive and active, of the affected limb.

To summarize, there are almost 5 million stroke survivors in the U.S., and 700,000 new

cases per year for whom effective UL rehabilitation is lacking. The vast majority of these cases

are hemiparetic, with UL involvement. Physiotherapy in most cases still consists primarily of

passive stretching and treatment for spasticity, despite overwhelming evidence that motor

recovery is possible by proper exploitation of residual limb function. Tools to help clients exploit

their residual functions are urgently needed.

a.i.2 Neurological Causes

Neuromuscular dysfunction is often the result of damage to the brain either via an

ischemic event or a traumatic injury to the brain. Cerebral ischemia is a common cause of

stroke, and is usually caused by sudden blockage of an artery supplying the brain or by low flow

to a distal artery that is already blocked or highly constricted. This blockage or constriction may

be the result of disease of the arterial wall, embolism from the heart, haematological disorders,or

various rare but treatable conditions[24].

Unilateral cerebral-hemisphere lesions cause contralateral hemiparesis. The forehead,

tongue, and bulbar musculature are unaffected unless the upper motor neuron lesion is bilateral,

however the lower facial musculature are affected. Focal lesions that affect only a portion of the

Page 2

motor cortex produce paralysis of the body part controlled by that point of the motor cortex.

Focal motor, or Jacksonian epileptic attacks that affects only one side of the mouth, the finger

and thumb, or the great toe, are typical of irritative lesions of the motor cortex. Lesions in the

internal capsule, even those that are minor typically lead to complete hemiplegia because the

corticospinal-tract fibers are densely packed.

In addition to motor impairments, cognitive and sensory deficits may also result from

lesions in the motor cortex. Typically, cortical or subcortical lesions produce cognitive deficits.

In contrast, lesions deep in the white matter frequently produce dense hemiplegia without

cognitive loss. Lesions in the medial section of the medulla oblongata may produce an ipsilateral

hypoglossal nerve deficit and contralateral sensory loss. This loss leads to contralateral

hemiparesis and affects the ability to sense vibration and joint position.

a.i.2.1 Muscle Weakness

Patients typically start to notice muscle weakness when they begin to have trouble with

walking. Proximal leg muscle weakness typically makes it hard for patients to climb or descend

stairs, stand out of a bath or arise from sitting without using the arms. Distal leg muscle

weakness causes ankle instability or foot drop, the inability to curl the toes into plantar flexion to

keep loose shoes from falling off the foot, or to grip the edge of a swimming pool to dive.

The patterns of weakness and the symptoms present can provide clues concerning the

location and severity of a lesion, and the pathology of the impairment. Lesions in the upper

motor neuron cause paralysis of the limbs. Severe lesions cause complete paralysis; less severe

lesions cause distinctive patterns of weakness. In the lower limbs, hip flexion due to the

weakening of the iliopsoas usually occurs the earliest, and hamstring and ankle dorsiflexion

weakness is often pronounced. Hemiparesis, affecting both the upper and lower limbs on one

side of the body is typical of a cerebral-hemisphere lesion. Paraparesis, or weakness of both legs

is usually result of thoracic spinal cord or cuada equine disease. Quadriplegia, the weakness of

all four limbs, suggests cervical spinal cord or diffuse neuromuscular disease.

Some now believe that muscle weakness is more harmful to function than spasticity.

Muscle weakness is a key component of cerebral palsy[25]. Palsy by definition is weakness

originating from the brain. Phelps theorized over 50 years ago, that resistive training would be

beneficial to children with CP. However, in the past there was a fear that near maximal effort

during resistive training would increase spasticity and muscle tightness, making the problem

worst. When this article was written (2002) there was still some opposition to resistance

training, despite evidence that supports such exercise.

Muscle weakness is not the only factor hindering movement in those with CP. Other

factors such as decreased central input to the muscle, changes in the elastic properties of the

muscles themselves, defects in the inhibition pathways of the agonist-antagonist muscle pairs,

and increased stretch responses or spasticity also contribute to poor function. Some of these

factors may actually be secondary, and thus preventable if the primary factors (i.e. muscle

weakness) are addressed. Some caution against trying to correct secondary factors because they

fear that doing such may actually increase muscle weakness.

Page 3

a.i.2.2 Muscle Stiffness

In addition to muscle weakness, muscle stiffness may also lead to decreased joint

mobility. Spasticity, rigidity or hypertonia can contribute to increased muscle tone. The tone of a

muscle is the response it shows to passive stretching. In practice, tone is assessed by moving a

limb and observing the reaction that occurs in the muscles that are being stretched. Muscle tone

is regulated by reticulospinal fibers that accompany the pyramidal tract and exert an inhibitory

effect upon the stretch reflex.

Abnormal ankle stiffness is a common aliment associated with ankle dysfunction. Ankle

stiffness is the relationship between joint position and the torque acting about it, which defines

the mechanical behavior of the joint. Ankle stiffness can be separated into two components,

intrinsic stiffness, and reflex stiffness. The intrinsic stiffness is due to the mechanical properties

of the joint, passive tissue, and active muscle fibers; whereas the reflex stiffness is the stiffness

component due to changes in muscle activation due to sensory responses to stretch. [26]. The

parallel cascade method developed by Kearney et al. has been used to separate the reflex and

intrinsic components of stiffness. This method allows investigators to determine whether neuro-

pathways, or mechanical properties of the muscles (i.e. flexibility) are damaged[24].

Galiana et al. [27] conducted a study comparing the intrinsic and reflex stiffness between

stroke affected and normal subjects. A bimodal distribution was found within the stroke group,

meaning there were some subjects in the stroke group with torques similar to those in the control

group, and some subjects in the stroke group with torques much higher than the control group.

Due to this difference, the authors decided to separate the stroke group into two subgroups:

stroke high reflex torque (SHRT), and stroke low reflex torque (SLRT). The intrinsic stiffness

was found to be similar for all groups; however, the reflex stiffness was higher in the SHRT

group. In addition, it was also shown that as the angle of dorsiflexion increased, the intrinsic

stiffness contribution to the overall stiffness decreases, and the reflex stiffness contribution

increases. These results confirmed that increased ankle stiffness in stroke patients is primarily

due to the neuromuscular components of stiffness and not to the mechanical properties of the

joint.

Despite the serious effect drop foot has on gait, there is very little in the literature

concerning its treatment. Even comprehensive textbooks tend to address this issue briefly,

typically only advising caregivers to use a brace that will keep the foot in dorsiflexion day and

night, with passive ankle flexing to help prevent atrophy.

a.i.3 Rehabilitation Utility

The strategy of neglect may be counterproductive, since disuse patterns and associated

pathology commence soon after immobilization of limbs1. Although it is not known exactly how

soon exercising should begin after traumas such as stroke, no evidence contraindicates beginning

within a few days, at least at a minimal level. Moreover, much evidence supports the value of

specific exercises throughout the recovery period [2-5, 10, 28-35]. Thus new resources, either in

the form of specially trained human therapists, or machine helpers targeted for the lower-limb,

are urgently needed in order to improve chances for functional recovery.

A rehabilitation tool that will be ideal for every user or situation is not realistic; however,

there are some user problems and abilities that are sufficiently common and fundamental to

provide design specifications for a highly useful device. Although compiled data on the

Page 4

characteristics of stroke patients are limited, some generalizations can be made as listed in the

following table, and are addressed by HARI:

Problem

Potential Residual

Ability

ROMAR Solutions

Irreparable damage to

areas of the brain that

formerly controlled one

or more limbs

Central nervous system

(CNS) plasticity;

Sensory perception

intact.

Re-learning movements through proper

training and sensory feedback to reduce

conflict.

Sustained attempts at re-activating task-

oriented motions; playing in a virtual

environment.

Weak ankle muscles

unable to lift the force of

the foot

Ankle muscles are able

to move lift forces.

Strength training orthotic device.

Co-contraction of agonist

and antagonist during

movement, i.e. „synergy‟

Muscle spindle afferents

are intact, but possibly

anomalous.

Stretching, weight bearing, and exercise to

reset muscles.

Loss of ankle dexterity Some extrinsic muscles

are usually active, even

in early recovery.

Staged protocols that begin with restoring

The primary utility of the proposed device is for re-training These features are useful for

both client assessment and motivation, and are crucial to winning public support for its value as a

therapeutic resource [36-38].

ii ) Related R&D

a.ii.1 Rehabilitation strategies for POA

Current methods used to treat POA, includes physical and occupational therapy, biofeedback,

surgery, drugs, and orthotics. All have been shown to be effective for certain groups. Both

function focused, and quality of movement focused therapies have been found to yield similar

results.[39] The standard treatment options are currently physical and occupational therapy, and

the use of orthotics. Recently, rehabilitation providers have begun using techniques such as

biofeedback and functional electrical stimulation to supplement both therapy and orthotics.

a.ii.1.1 Strength Training

A major part of physical therapy is muscle training, which changes muscle contractile properties,

such as strength and contraction speed; as well as the ability of the nervous system to control

muscular function[38]. Strength can be increased by an increase in muscle size or an increase in

the net neural drive to the muscle. For older persons, hypertrophy may be limited and strength

gains may depend on more neural factors [37].

Neural factors are the primary cause of strength gains in the first two to eight weeks of

strength training, when subjects are still learning how to exert force effectively. Strength training

enhances synchronous muscle fiber recruitment (resulting in the summation of force) and

reduces inhibition of motor units. Usually, each motor unit receives signals from several motor

units, including some that are inhibitory. By reducing inhibition, more units can become active,

Page 5

thus increasing the force output. Strength training also tends to decrease the activation of the

antagonist muscles opposing the desired movement, and increase the activation of the synergist

muscles that assist the muscles making the desired movement. However, a significant change in

muscle spasticity as a result of strength training has not been found.

Isometric and isokinetic training are the two most common methods of improving muscle

strength. Isometric contraction provides a measure of the muscle's maximum strength and is

dependent on the length or angle at which the muscle is held. Isokinetic knee extension can

change the shape of the force-velocity curve for the quadriceps, which in turn increases the

power of the muscle. A dynamometer is used for both types of training.

Isokinetic testing at slow speeds can reliably improve strength in those with CP and those

with other spastic disorders for certain muscle groups. The method of producing strength gains

in CP appears to be the same as those for other chronic motor disorders. However, due to

shortened muscles, alternative test positions may be necessary. During rehabilitation, therapists

are careful to avoid positions that inhibit the use of flexor and extensor synergies (muscles that

assist the main muscle producing the desired force).

a.ii.1.2 Orthotics

It is common for those with drop foot to wear an ankle foot orthosis (AFO) while ambulating.

The AFO may be the only orthosis worn or it may act as a basic component for a more extensive

orthosis system. AFOs may come as dynamic (DAFO) or molded (MAFO). The DAFO

contains a custom contoured foot-plated designed to promote balance of muscle power and to

reduce the need to seek stability through compensatory balancing methods. Examples of a

DAFO include inhibitory casts and inhibitory orthoses, which are sometimes referred to as

inhibitory AFO, tone-reducing AFO or neurophysiologic AFO. The MAFO does not have a

custom contoured footplate. Therefore, it usually does not offer support for the arches or to the

toes. However, with some modification it can offer support for the arch of the foot[40].

In addition to differences in fabrication, AFOs vary in the amount of restriction or

assistance of ankle movements. AFOs may come as fixed, hinged, dorsiflexion-assist, or ground

reaction. A fixed AFO provides support and position for the ankle and the subtalar joint. They

are typically used for patients that have little or no voluntary control of dorsiflexion, or excessive

knee extension during weight bearing. The trim lines of the fixed AFO can be used to control

the amount of forward movement of the tibia. The tendency to flex the knee at initial contact can

be limited by setting the trim line at 2°-3° of dorsiflexion. Setting the dorsiflexion to 5°-7° can

limit the tendency for knee hyperextension at stance.

A hinged AFO allows dorsiflexion and/or plantar flexion at the ankle. However, most

often the hinged AFO blocks ankle plantar flexion while allowing dorsiflexion. The hinged

AFO is used for patients that have at least some voluntary control of dorsiflexion, but no control

of plantar flexion, or for those with limited voluntary control of both plantar flexion and

dorsiflexion. A spring loaded dorsiflexion assist can be used together with a hinged AFO to

allow for the passive dorsiflexion of the ankle.

Dorsiflexion assists are generally used for patients that have a sufficient range of passive

motion but limited or no voluntary control or dorsiflexion or plantar flexion. A dorsiflexion

assist AFO may come in plastic form in either a spiral shape that coils around the shaft of the

lower leg and supports the foot or as a posterior leaf-spring orthosis. All of these AFOs except

for the spiral are able to limit mediolateral motion by extending the plastic over the sides and the

top of the foot.

Page 6

A ground reaction AFO is molded to fit around the front of the leg. Ground reaction

AFOs are used for patients with excessive knee flexion, and ankle dorsiflexion during weight

bearing. The straps on the back of the leg hold the leg and heel in place, and along with the

anterior shell, limits the forward movement of the tibia at initial contact and throughout the

stance phase of gait. This orthosis may enable the wearer to maintain a full upright posture by

limiting the dorsiflexion range [40].

a.ii.1.3 Biofeedback

A large body of evidence supports the value of neuromuscular biofeedback for motor recovery

[30, 33, 34, 41-61], and there is much interest on the part of the stroke community [62]. Current

methods of biofeedback involve displaying EMG recordings of specific muscles, while the

subject tries to either amplify or reduce them. For example, a recent study randomly assigned 36

patients with spastic cerebral palsy to either control or EMG feedback group. For 10 days the

biofeedback group received biofeedback 30 minutes a day, plus conventional exercise for 2

hours a day, and the control group received conventional exercise 2.5 hours a day[60]. The

biofeedback group displayed statistically significant improvements in the tone of the plantar

flexor muscles and active range of motion of ankle joints. Both groups showed statistically

significant improvements in gait function, however the biofeedback group showed more progress

than the controls.

a.ii.1.4 Functional Electrical Stimulation (FES)

Functional electrical stimulation (FES) is the application of electrical current to excitable tissue

to augment or replace function that is lost in individuals with neurological impairments. FES can

be used to restore both sensory and motor function. Functional restoration is accomplished by

electrically activating the intact lower motor neurons using electrodes placed on or near the

innervating nerve fibers. The electrical stimuli elicit action potentials in the innervations axons,

causing a muscle contraction. The strength of the muscle contraction is regulated by modulating

the pulse frequency, amplitude and duration. A functional limb movement can be induced by

coordinating the electrical activation of several muscles[63] .

The threshold charge needed to elicit action potentials in muscle fiber is much greater

than the threshold needed to produce action potentials in the neuron. Therefore, FES

applications for motor function typically work by electrically stimulating the nerves associated

with the muscles needed to produce a movement. To activate muscles using this form of FES,

the lower motor neurons must be intact from the anterior horns of the spinal cord to the

neuromuscular junctions. Patients with spinal cord injury, stroke, head injuries, cerebral palsy,

and multiple sclerosis are good candidates for neuromuscular electrical stimulation when the

lower motor neurons are excitable and the neuromuscular junction and the muscle are healthy.

Stimulators can be designed to regulate current or voltage. Voltage-regulated stimulation

is often used for surface stimulation applications in order to minimize the possibility of skin

burns that may result from high current densities. However, because the electrode impedance

can affect the current delivered by the voltage regulated stimulator the motor response is more

variable.

One of the first applications of FES was preventing the foot from dragging on the ground

during the swing phase of gait in patients with post-stoke hemiplegia. These systems used

surface electrodes positioned on the tibialis anterior and on the common peroneal nerve where it

crosses the head of the fibula, a stimulator implanted in the medial thigh region, or a stimulating

Page 7

electrode implanted on or near the personal nerve. Stimulation was activated with a heal switch

worn in the shoe of the non-impaired foot.

The early work demonstrated the efficacy of FES for foot drop; however, there were

many shortfalls with these systems. Those working with the early FES systems experienced

problems placing the surface electrodes, false triggering of the stimulation, inadvertent elicitation

of reflex spasms in the plantar flexor muscles, pain or discomfort from the stimulation,

mechanical failure of the switch or other components and difficulty achieving balanced

dorsiflexion with a single electrode. Currently several foot drop systems are already or close to

being commercially available[63].

a.ii.2 Outcomes Assessment One limitation that plagues interventions for POA is the difficulty in assessing outcomes.

These limits particularly apply to assessing hand function, probably because the complexity and

adaptability of the human hand do not easily yield to simple objective measurements. Most real

tasks can be accomplished in an infinite number of ways by the human hand. Thus, measures of

hand performance, such as the Fugl-Meyer, Action Research Arm Test, and Upper Extremity

Motor Assessment Scale [64, 65], are narrow and based on subjective ratings. Objective

measures of overall a function, i.e., dexterity, are not yet standardized. Recent efforts to

standardize functional indices are useful, such as the Southampton Hand Assessment Procedure

[65], however these are focused mainly on grasping ability relative to prosthetic function.

a.i.3 ROMAR in comparison with other devices

There are very few commercially available devices that attempt to restore ankle function.

When applied at all, current rehabilitative approaches are far from optimal. The regimens and

devices that are available are generally too impractical and costly for most individuals, they

require expert assistance, and the more advanced approaches are unlikely to be widely available

soon. More significantly, they offer little assistance for neural recovery, focusing either on

developing compensatory strategies through bracing, or on passive movements of the joints with

robotic devices. There is one new exceptional device that does address brain recovery, with the

use of a camera based virtual reality system. However, this system is expensive and requires a

special background making it difficult for many consumers to implement at home.

Another device, the Rutgers Ankle, is a virtual-reality robotic ankle device designed for at-home

use and Internet-based remote monitoring by therapists. This system incorporates a six degree of

freedom Stewart platform that [66]…[Insert more Rutgers Ankle info].

Most devices for biofeedback rely exclusively on the EMG, with the Brucker method being

the most popular [62]. As stated earlier, EMG is not an in home option due to its complexity, and

patients can only get the treatment at one of 6 Centers in the U.S. ROMAR thus fills a niche for

ankle rehabilitation. Its most distinguishing feature is that it is specifically targeted to promote

central neural recovery. It offers a simpler biofeedback method that can be self-administered at

home, and can provide interesting games and tasks, while documenting progress with

quantifiable outcomes.

Page 8

b) Quality of the Project Design 1. Phase I TECHNICAL OBJECTIVES

This project will improve the ROMAR prototype developed for motor learning studies and test

its efficacy with a pilot study of 5 stroke or control subjects. Specific objectives are:

Objective 1: Redesign ROMAR :

i. Mechanical design and drawings of platform, bearings and component housing.

ii. Ordering parts, machining and Rapid prototyping (if required).

iii. Assembling ROMAR Platform.

iv. Making improvements to current software to enhance ease of use.

v. Bench testing.

Objective 2: Train subjects with stroke on ROMAR protocols for 1 day.

i. Recruit subjects

ii. Train 5 subjects for 1 sessions each

iii. Determine outcome

2. Preliminary Results

2.1 Fabrication of the platform Initially, an industrial joystick was to be used because it is capable of providing more reliable

goniometric measures than a gaming joystick. However, the industrial joystick was not as sturdy

as the gaming joystick and actually fell apart during preliminary testing. Furthermore, the

industrial joystick gave too little resistance, which caused the ankle muscles to fatigue quicker;

therefore the Logitech attack 3 USB joystick was used.

The platform has a wooden base that is used to secure and position a Logitech Attack 3

potentiometer joystick. The joystick is positioned upside down, with the base parallel to the

floor. A foam layer is between the joystick and the wooden base to protects the joystick from

excess force. A sandal attached to a plastic plate is mounted onto the base of the joystick in order

to secure the foot.

Page 9

Figure 1(Left) Screenshot of the ROMAR front panel. (Right) The foot platform.

2.2 Programming

The software interface written in LabVIEW allows the user to play three games; a bird game that

allows the user to practice dorsiflexion and plantar flexion while trying to avoid moving blocks;

a boat game that allows the user to practice inversion and eversion while trying to avoid moving

logs; and a mole game, which involves a combination of all four movements.

User LoginGame

SelectionCallibration

Biofeedback

Game

Figure 2 Block Diagram of User Interface

Prior to each game, the system is calibrated to fit the users‟ maximum range of motion by having

the user perform the required maximum movements. After calibration, the user can decide to use

either continuous movement or sustained contraction (in which the user must sustain their

maximum inversion, eversion, plantar flexion or dorsiflexion) to play the games. The user also

has the option of decreasing the speed of the game if it is too difficult, or increasing the speed to

provide a greater challenge.

Page 10

Fig. 3. Screenshot of the ROMAR front panel is shown. The user has a choice of three games: The bird game is used to

practice plantarflexion and dorsiflexion, the boat game is used to practice inversion and eversion, and the mole game is

used to practice all four movements.

2.3 Subject Testing

A LabVIEW program was created and used to record the joystick output and convert it to an

angle measurement. Six trials were conducted, three trials for dorsiflexion (positive angles) and

three trials for plantar flexion (negative angles). Using a protractor the joystick was initially

positioned at ninety degrees (which is considered zero for the ROMAR device), using the rear

most rivet (the approximate location of the ankle) as the pivot point. The joystick was then

moved in increments of five degrees, in either the positive or negative direction. The joystick

was held at each position for five seconds. A MATLAB program was used to determine the

average raw output value for each angle. The best-fit line was calculated for the data using

Excel, and later used to determine the angle the ankle moved while the foot was in the ankle

device.

Figure 4 Correlation between raw joystick output and joystick angle.

y = -9E-09x2 + 0.000x + 3.596R² = 0.992

-20

-15

-10

-5

0

5

10

15

20

-40000 -20000 0 20000 40000

An

gle

(d

egr

ee

s)

Raw joystick output

Page 11

The ROMAR device was then tested on six subjects, three hemiparetic stroke , and three

unimpaired to determine feasibility of unipedal, bipedal, and monopedal protocols. The

experimental setup consisted of two platforms placed side-by-side, approximately hip width

apart. However, data was only recorded from the platform under the affected foot.

Subjects were asked to play seven rounds of the bird game. The first round was a practice round,

meant to allow each person to become familiar with the game. The following six rounds were

used to test the different conditions. The game was played at two speeds 30 flexions per min and

70 flexions per min (70 flexions per minute is equivalent to slow walking). For each speed, the

game was played to test the following three foot movements, unipedal (one foot), monopedal

(two feet in phase), and bipedal (two feet alternating).

The results were analyzed by calculating the mean velocity, acceleration, and normalized

jerk (a measure of smoothness). Normalized jerk was calculated using the following formula

[67]:

dttjD

TNJ )(5. 2

2

5

where, T=the total elapsed time, D=the total distance traveled, and j=jerk (the third derivative

of position). An ANOVA was performed to determine whether the difference in means were

statistically significant.

Tables 1 summarizes the mean values calculated from the clinical evaluation of the ROMAR

system.

Unipedal Monopedal Bipedal

Pla

nta

r fl

exio

n

Healthy

Flexion Range 16.88 17.44 16.86

Velocity 19.25 17.27 19.4

Acceleration -20.49 -15.95 -11.79

Normalized jerk 8.5 2.11 4.66

Stroke

Flexion Range 13.17 12.03 13.63

Velocity 12.47 10.34 11.73

Acceleration 0.28 -30.37 -30.02

Normalized jerk 12.1 4.05 4.66

Dors

ifle

xio

n Healthy

Flexion Range 12.6 9.54 10.74

Velocity 18.51 19.17 19.57

Acceleration 4.58 34.48 22.63

Normalized jerk 2.86 3.48 4.57

Stroke

Flexion Range 11.44 8.42 9.81

Velocity 13.74 9.38 12.37

Acceleration 4.58 34.48 22.63

Normalized jerk 12.1 4.05 4.66

Page 12

Table 1 Mean plantar flexion and dorsiflexion values.

An ANOVA revealed a main effect for the type (unipedal, monopedal, or bipedal) of movement

(p=.01). To understand the cause of this main effect a pairwise comparison of the three

movements were conducted with a Bonferroni correction; since there was an n of 6 the

correction causes the new significant p value cutoff to be 1.67 ( ). The range of motion

was found to be significantly higher for the unipedal movements (13.52 °±1.60°) than for

monopedal movements(11.86° ±1.96°) (p=.02). The range of motion for bipedal movements

(12.76° ± 1.82°) was not significantly higher or lower than the range of motion for the unipedal

or monopedal movements. There was a significant interaction between movement and flexion

(p=.03). A pairwise comparison revealed that the cause of this interaction was significantly

larger (p<.01) dorsiflexion range for monopedal movements (12.02° ± 2.26° ) than for bipedal

movements (8.98° ± 2.77°) . There were no significant differences in the range of motion

between the stroke and healthy participants.

The velocity, acceleration, or normalized jerk did not prove to be significantly different

between the three types of movements or the two flexions. There was however a significant

difference (p<.05 for both) in the average velocities and normalized jerk of the two groups. The

healthy group had a significantly higher velocity (18.86 ± 1.36) than the stroke group (11.67 ±

1.36). The stroke group had a significantly higher normalized jerk (11.42 ± 1.72) than the

healthy group (4.31 ±1.72). There were no significant differences in acceleration between the

two groups.

The results suggest that the three different movements did in fact elicit different range of

motion behavior from the ankle. Monopedal movements which are not typically used in daily

activities of living yielded the smallest range of motion. The lack of practice with this type of

movement may be the cause of this reduced range. It is believed that the two groups did not

show a difference in range of motion because the movements required by the game were well

within the range of the two groups. It is possible that a game that requires the participants to

make larger movements would show range of motion differences. As expected the stroke group

tended to produce movements that were slower and jerkier than the healthy subjects. These

findings illustrate that the ankle device and game are capable of capturing and quantifying the

differences between an impaired and unpaired patient group.

2.6 Conclusions

Preliminary results with ROMAR have demonstrated its accuracy and usability by stroke

patients, and its ability to quantify motion smoothness as well as ROM[68]. . Objective

measures of functional performance outcomes are crucial to successful treatment with AFOs.

The AFI system provides a simple means to quantify ankle function, to help design the AFO as

well as evaluate its utility. Additionally, the system can encourage clients to exercise while

receiving biofeedback in an engaging environment.

3. Phase I Work Plan

iii.1 General

Page 13

iii.2 Design specifications

ROMAR will have the following features:

Adequate support for foot and shank weight during flexion

Two degrees of freedom (two joints)

Small and light enough to be portable.

Allows for 20 degrees of plantar flexion, 15 degrees of

dorsiflexion, and 10 degrees each of inversion and eversion.

Convenient to use, with no or minimal assistance.

Accurate and clear feedback in a simple display.

iii.3 Product options

The basic ROMAR system consists of the Ankle Platform, an electronic interface, and a

display device. Since we foresee at least 3 different situations in which HARI will be used, we

propose 3 versions of ROMAR , representing a full, intermediate, and low-end system:

Version Components

Application

300

Clinic

Version

Motorized ankle Platform, interface

High resolution interface electronics,

and computer software.

Full version for provider.

200

Standard

Home

Version

Motorized ankle Platform, interface

electronics, computer software.

Versatile home use: System will be

able to determine forces needed to

make the foot level, prior to

performing exercises.

100

Light

Home

Version

Ankle Platform, analog interface

electronics, computer software.

Low-end home use: User must adjust

the platform to make the foot level,

prior to performing exercises.

Materials cost estimate is as follows:

Component

Source Cost

Sandal CG Medical $300

Plastic Plate CG Medical $ 30

Springs McMaster-Carr $ 20

Mountings McMaster-Carr $ 50

Sensors Interlink Electronics & Various $ 50

Data acquisition board National Instruments $200

Cables, etc. Creatone-NCI $ 100

iii.4 Task 1: Finalize the mechanical arm support and tracker (MAST)

The starting point for MAST development will be Version 4 discussed in Phase-I results.

MAST guides arm reaching motions with 4 DOFs, in an open kinematic chain as depicted below:

Page 14

top view

Open kinematic chain of 3-D HARI.

The figures above depict the joints of MAST. MAST supports the weight of the arm (from

below), supporting hand trajectories within a 3-D envelope extending vertically from 20 below

to 30 above horizontal and horizontally in a 60 arc centered about the forward pointing

position. Joints are variable friction, but lockable for stabilizing postures. The 3 degrees of

freedom at the shoulder are provided through lockable joints, allowing freedom of movement in

adduction/abduction, flexion/extension, and rotation. The elbow joint has a ratchet or lock that

can be extended progressively for anti-flexion. The wrist will be free to pronate/supinate and

perform radial and ulnar deviations. A gripping target is at the end of the MAST (not shown).

All joints allow three types of operations: (a) free movement within the designed range of

motion, (b) variable resistance, and (c) locked at the desired angles. Electro-goniometers made

from rotary potentiometers measure the angles at the joints. Other design considerations for the

MAST include simple switch from right to left arm use. Performance specifications are

summarized below:

MAST Specifications

Four DOFs

Goniometric outputs from joints, providing

horizontal axes for computer cursor control.

Compatible range of motion

Integral target with switch interface to computer

Incorporated sensors for myokinetic activity

Lockable elbow and shoulder joints for

stabilization and isolation

Smooth joints

Ease of donning

Ambidexterous (switchable between right and

left)

Chair mounts

Full arm weight support + dynamic strength to

resist muscular action.

Comfortable with Velcro attachments

iii.5 Sub-tasks:

i. Develop a versatile mount for the MAST The arm support is affixed to a standard chair arm with a tubular link between it and the chair

bracket, as shown in Figure ##, Phase I results. The tube is a standard prosthetic pylon with

screw mounting brackets used for lower limbs. Vertical height of the arm support can be

easily adjusted for a range of body sizes. The bracket will mount on a variety of chair arms

with large wing-nut fasteners. Sufficient adjustability in the saggital plane is required to fit

Page 15

most adult body widths. The target range is for 1 inch, to move the pylon closer or farther

from the chair center, so that it is directly in line with the shoulder. The design for the

mounting hardware will be rendered in CAD drawing, and fabricated by the machine shop.

The only machining required is for the chair arm fastener, all other components are „off-the

shelf.‟

ii. Instrument MAST with goniometers for elbow and shoulder.

We will use potentiometers for registering angles, similar to that described in Phase I.

Potentiometers will be mounted into the joints, and their resistance outputs will indicate position.

Standard circuitry and interface for these were developed in Phase I.

iii. Instrument MAST with myokinetic sensors Performance specifications of the MKI sleeve are:

High sensitivity to trace muscle activity from arm.

No need for precise anatomical positioning of sensors.

Convenient to use, with no or minimal assistance.

No need for electrodes or gel.

No long cables.

Reliability for deciphering volition.

Accurate and clear feedback in a simple display.

To achieve the above specifications, force sensing resistors (FSR) sensors will be

incorporated into the fabric of the MAST, either directly or by attaching sleeves. Sensory sleeves

for recording myokinetic activity from the forearm of hemiparetic users are adapted from

standard fabric orthoses, costing $10 (Orthobionics, Dallas, TX) that are made in left and right

varieties in multiple sizes. Each sleeve contains as many as 16 FSR sensors incorporated into

foam lining of the orthosis. Forearm sensors are mounted with variable spacing and density over

the anterior and posterior surfaces according to anatomical structures, being concentrated in

areas near finger flexor and extensor muscles (anterior and posterior aspects of forearm). Upper

arm sensors are placed to register the triceps and biceps muscles. Electrical currents through the

sensors are minimal, and a battery provides power.

The dynamic range of FSRs is suitable for detecting superficial forelimb and biceps/triceps

activity, which varies from a few grams to as much as 500g. The foam lining of the orthosis

ensures an intimate apposition to the forelimb and provides a pre-activity stress which allows the

sensors to detect negative, as well as positive changes in pressure that are essential for

identifying unique pressure patterns.

Operation of the sensor sleeve will be as follows: the client will place his affected arm in the

MAST, generally with assistance either from his sound arm or a helper. The arm should

preferably be exposed, for direct skin contact, however a tight-fitting shirtsleeve would be

acceptable. He will then comfortably tighten the velcro straps at the triceps cuff and forearm and

then be ready to train.

iv. Incorporate the GRIP into the MAST

Page 16

The terminus of the MAST will be a foam ball instrumented with a switch and FSRs,

that will be used to assess grip strength and control a mouse button. The GRIP will serve as

a target for reaching and computer interface (see Task 2).

.

Task 2 : Productize Dextra

i. Electronic Processing (Dextra Microcontroller)

. All data acquisition and first stage signal processing functions will be transferred to

Dextra. Dextra may be used as a portable stand-alone unit using it‟s integrated LCD display and

an auditory beeper for feedback. Dextra will also be interfaced to a PC for more complex

display and data processing functions. Use of Dextra will enable portability and allow testing at

multiple locations, as well as possible home use.

Three prototype Dextra boards have been manufactured, programmed and tested for

simple data acquisition, serial communication, and display functions. Communication with

Dextra is via serial port, keypad, beeper and liquid crystal display. These features allow a

versatile user interface for programming, user-adjustments, and diagnostics. Analog

components, including amplifiers, filters, bridge circuits, and pressure transducers, will be

mounted on a separate daughter board. Prototype sensor arrays may have more sensing elements

than available analog input channels, currently 8 channels. Multiplexing circuitry can be

implemented to accommodate up to 64 input signals. The Dextra microcontroller unit is about

the size of a small camera and may be worn on the outside of the clothing.

ii. Program signal acquisition and processing

All data input from HARI, as well as preliminary signal processing functions, will be

transferred to the Dextra microcontroller unit. In stand-alone mode, Dextra will also perform

more advanced signal processing and feedback functions, as well as store data for later

examination and analysis. In its alternate PC interface mode, Dextra will pass processed data to

a PC and an expanded program will implement advanced signal processing, user feedback and

data collection.

During attempted movements, signals from HARI will be processed with a trained filter to

encode and discriminate specific intended motions. The program will then move displays or a

virtual limb in accord with user volitions. Volitions originate in the motor cortex and travel

through central processing circuits, nerves, and muscle, and are expressed as kinetic activity in

the limb. Mechanical activity on the limb surface represents volition after degradation through

the entire system. This system can be characterized by a degradation function, and its inverse, a

restoration function, can discriminate specific volitional motions.

Volition degradation is characterized by a system of linear equations [69]

g = Hf

where f is a column vector representing intended activity, H is a matrix of kinetic responses

representing volition degradation through the neuromuscular system, and g is a column vector of

Page 17

measured kinetic responses. Approximations of f could be obtained by applying the inverse of

the degradation function to the measured responses according to

f̂ = H-1

g.

To obtain g, subjects are instructed to perform specific reaching and grasping volitions,

according to their abilities, while the HARI measures joint motions and mechanical activity on

the limb surface. Five or more repetitions of each independent volition are performed with

moderate intensity, simulating repeated impulses to the system. A response vector is then

constructed from the average peak magnitude of the signal measured on each sensor channel.

Repeating the process for other independent volitions provides unique response vectors. The

response vectors associated with specific volitions form the columns of the kinetic response

matrix H. Generally, the number of sensors in the array and the number of independent motions

are different, so the response matrix is not square. Therefore, H-1

is the pseudoinverse of H,

computed through the singular value decomposition of H.

The program acquires and filters data, and displays signals representing user intent. The

pseudoinverse filter coefficients are obtained for each subject from an initial training procedure,

during which the user is prompted by visible and audible cues to allow baseline measurements

and perform multiple repetitions of specific motions. These motions include movement of the

shoulder, elbow, wrist, and fingers. Upon completion of training, subjects can practice operating

a virtual arm display that responds to the filtered signals. If the subject loses control of the hand

during operation, attempts are made to re-train the filter.

iii. User interface

Two different types of user-interface are available, depending on whether Dextra is used in

portable stand-alone mode or in conjunction with a computer. The Dextra unit will be

programmed for use in both modes for maximum versatility. User communication is via the LCD

display, a beeper, and a keypad. Dextra will be programmed in a combination of C and assembly

language using the Keil μVision2 integrated development environment. Computer programs will

initially be written in LabView. A variety of other programming languages, including Visual

C++, Java, etc. may be used to provide advanced functionality.

iii.a. Dextra in Stand-Alone mode

In Dextra portable stand-alone mode, the user-interface comprises a touch keypad, a

liquid crystal display (LCD), and an optional audible beeper, in addition to the HARI sleeve and

MAST. The LCD is capable of displaying both text and graphics. Initially a menu of programs

choices will be presented to the user, and program options will be selected with the keypad using

the non-paralyzed hand. The affected arm and hand will be secured in the HARI sleeve and

optionally in the MAST, and signals from the FSRs attached to these will be input to Dextra.

FSR signals will be processed and feedback will be presented to the user via the display and

beeper. For instance, a simple bar display on the LCD that varies in length, or tones of varying

pitch, may give feedback on the overall strength of input to the FSRs. Other types of feedback

will be implemented depending on user preference.

iii.b. Dextra interfaced to a computer

Page 18

Serial communication between Dextra and a computer is two way. Thus, when operating

in conjunction with a computer, the user interfaces of the computer, i.e. the keyboard, display,

speakers, and mouse, are available in addition to those of Dextra. Other devices, such as the

GRIP, may also be used. In combination, these provide a virtually limitless array of possibilities

for program development and user feedback. Only a small subset of these will be implemented

in Phase II. Additional options will be implemented as commercialization progresses.

When Dextra is interfaced to a computer, the client‟s non-affected hand may operate the

keyboard and/or mouse to select menu options. Three basic types programs will be

implemented. The first will be a modification of the LabView program; a second program will

use a virtual display that responds by performing intended arm and hand motions detected by

filtered FSR signals, as described above. The third program will allow the user to play simple

games using the GRIP device. For instance, a simple helicopter game has already been tested by

one subject. In order to avoid an obstacle, the user must manipulate the helicopter to either

ascend, by squeezing the GRIP, or to descend, by releasing the GRIP. We plan to implement at

least two more simple games during Phase II.

iv. Program Provider Reports

To track user progress, a log of both raw and processed signal values of MKI and

goniometrics will be maintained either in the Dextra unit or on the computer, depending on the

mode of operation. At the end of each session, a report on the processed signals will be available

for display so that the user may see his progress during the session. In stand-alone mode, this

display will be on the Dextra LCD. When used in conjunction with a computer, the display will

be on the computer. Data from stand-alone use can also be uploaded to a computer for later use.

We will also investigate the feasibility of using the stored data to track the progress of the

therapy. Due to the nature of the signal processing, the raw data are more likely to provide a

measure of long-term progress than processed signal values. There will be variations in MKI

signals from day-to-day due to variations in the donning of the HARI, however these are

minimized by the structure of the MAST, and will tend to average out over many sessions.

Donning variations do not influence the biofeedback value of the MKI signal, since the goal is to

modify them in the correct relative direction during each session.

Task 3. Train stroke subjects on HARI protocols.

i. Recruit subjects The plan is to recruit (at least) 24 subjects (12 each of 2

years) with stroke. Subjects will be drawn from a large local base that are served by our present

contacts. These include our Phase-I consultants Dr. Bansil, and Dr. Deutsch, and Kessler

Rehabilitation Institute, in West Orange, NJ. Dr. Bansil is a Neurologist at Robert Wood Johnson

Medical Center, with a large patient base, who is one of the most prominent stroke Physicians in

New Jersey. Dr. Deutsch is a Physical Therapist specializing in upper limb rehabilitation after

stroke, and is on the Faculty of UMDNJ in Newark. Dr. Tom Findley of the East Orange VA,

will help recruit, and has indicated that over 50 new stroke cases are admitted to the hospital

each year, and that he oversees a national VA study of stroke involving 5000 patients.

Advertisements will be sent to these providers and local Rehabilitation Centers.

Page 19

Inclusion and exclusion criteria include the following:

Inclusion: All test subjects will :

Have a minimum of 20/40 visual acuity in at least one eye

Be between ages of 40-70 years of age.

Have experienced a cerebral vascular accident a minimum of 12 months prior to time of

testing.

Have a left-sided stroke, with right sided paralysis (one of 3 levels)

Exclusion:

Previous history of other neurological disorders (i.e. multiple sclerosis, epilepsy)

Previous history of severe psychiatric disturbances (i.e., schizophrenia, dementia, psychosis)

Participation in current rehabilitation therapies or interventions.

Severe cognitive impairment, as measured by the Cognistat screening measure.

Diabetes

Subjects meeting the criteria will be entered into the study following informed written

consent. The Rutgers University Institutional Review Board has approved the study, #03-305,

and IRB approval from UMDNJ has been obtained. An initial screening exam will be performed

by questionnaire and by direct palpation and observation of the arm during requested arm

motions. Since the affected limbs may be quite weak and subject to fatigue, we will minimize

the number of tests. Clinical observations (with our physical therapist consultant, Dr. Judy

Deutsch) will be made of the forearm to assess strength of the shoulder, elbow, wrist, and

fingers. For each joint, shoulder, elbow, wrist and fingers, a standardized scoring will be applied:

Score Function

5 Excellent No impairment

4 Good Movement against gravity, and some resistance

3 Fair Movement against gravity, but unable to move against resistance

2 Poor Movement with gravity eliminated

1 Trace No limb movement, but can feel muscle movement

0 Zero Not able to feel muscle movement= nothing

In addition, standard measures of UL performance, including the Fugl-Meyer, and Brunstrom

[64]

will be done. Others, such as Action Research Arm Test, and Upper Extremity Motor

Assessment Scale may be done if time permits. The goal is to enter 8 subjects in each of the 3

categories, defined as:

Level Category

Criteria

Shoulder Shoulder score 4; Elbow & Hand score < 3

Elbow Shoulder score 4; Elbow score 3 ; Hand score 3

Hand Shoulder & Elbow scores both 4; Hand score >0 but 4

ii. Train subjects

Page 20

ii.a Study Design . Once entered into the study and assigned to a functional category,

subjects will be randomized to either the test or control group. The control group will not

participate, and will carry on usual activities, for at least 3 months, when they could be called

back to crossover and begin the test procedure. In this way, subjects can serve as their own

controls, and fewer total subjects are needed. Since 12 subjects need to be tested for one quarter

of the year, the typical subject load will be at most 4 subjects at any one time. The 2 Biomedical

Engineering graduate students will be doing the training protocols with the clients. The overall

Page 21

testing sequence is shown in the figure below.

Graduate?

Meet Criteria and

Pass Cognitive?

Randomize to

control or test

Graduate?

Begin Shoulder

Protocol

3 months

Graduate?

Begin Hand

Protocol

3 months

Identify stroke

candidate

Group assignment

Based on UL

Function Tests

Functional

Inventory

Functional

Inventory

Functional

Inventory

Begin Elbow

Protocol

3 months

Functional Arm

Inventory

Baseline

No- Dismiss

3 month

training

Yes YesYes

No

Control for 3 months

8 8

8

Then Crossover

to test group

Yes

Finish

Note that subjects who enter at the lowest functional level (shoulder group) could re-enter the

study at the higher level if they improve to meet the higher criteria.

Page 22

The main questions we seek to answer are:

What level of assistance do clients of each level need for use of HARI?

Are 40 minute training sessions comfortably tolerated?

What types of feedback displays are most desirable?

Does the 3 month training protocol improve UL function?

We will determine the ability of subjects to don HARI unaided, in relation to their functional

level. We will test the efficacy of hierarchical stratification of clients into separate protocols

geared to their functional level: those with only shoulder control, those with both shoulder and

elbow control, or those with shoulder, elbow and some hand functionality. Training for all clients

will consist of reaching for specific targets, with protocols driven by HARI. with enhanced

visual feedback, and to encourage, through targeted rehabilitation, graduation of those in the

lower 2 function groups into the higher group. We hope to develop predictive models for stroke

recovery prospects, and establish correlations among rates of shoulder, elbow and hand recovery.

The unifying principle of training will be to encourage the correct expansion of residual

reaching and grasping movements. In some protocols, subjects will be asked to make the

selected reaching motions with their sound arm. Patterns will be recorded and quantified using

HARI. Next, they will attempt to reproduce these motions with the affected arm, while watching

a display of the moving mirror image (virtual) of their sound hand. The difference in motions

between the mirror image and their actual motion will be displayed. They will be asked to train

their actual virtual image to mimic the mirror virtual image. This protocol will be applied only

to the highest functioning group.

ii.b Sample Protocols Detailed protocols will be devised in consultation with Dr. Deutsch.

Based on Phase I observations of subject abilities, the following starting protocols are suggested.

Each of the tasks are done with HARI, with the goal of reaching a target:

Functional Level Tasks

Low: Shoulder

control only

1. Abduct/adduct shoulder with elbow flexed and

with elbow extended.

2. Extend/Flex shoulder with “” “”

3. Attempt elbow extension while doing (1) and (2).

4. Lock elbow and do isometric load bearing.

Medium: Shoulder

and Elbow control

1. Extend elbow to reach target.

2. Extend elbow and grasp target.

High: Some wrist

and hand control

1. Reach and grasp GRIP.

2. Modify grasp type with different finger combinations.

3. Play games and control cursor.

Thus the highest functional group will also be trained to reach, but with the added task of

grasping and possibly manipulating objects. Grasping will be similarly quantified from the

sound hand. Tasks of increasing complexity will be presented during the training period.

Page 23

For some subjects, part of the protocol will involve training the sound hand with a difficult

reaching task, whereby the object coordinates are translated with respect to HARI kinematics,

forcing the user to learn the transformation. The ability of the affected arm to learn this

transformation will be tested, in order to determine inter-manual learning transference.

Goniometric measurements of joint range of motions will be confirmed with a standard

manual goniometer. Digital videos of the motions will be recorded. Following completion of 3

months, a functional assessment will be repeated. If subjects in the shoulder or elbow groups

meet the criteria for the higher group, they will be given the option to graduate and begin the

higher-level training. The Figure below outlines the general protocol sequence for stroke

subjects.

Threshold

Control?

Threshold

Control?

Try volitional motion B while

feeding back muscular effort

Score Better?

Visual and quantitative

outcome

Add new Motions C,D,

etc.

Discriminate motions A and

B while feeding back

muscular effort

Try volitional motion A while

feeding back muscular effort

No

Yes

No

Strength

Movement A

Control

FailSuccess

Movements

A & B

Yes

More

Movements

Page 24

iii. A. Determine outcome

Measuring outcome of arm rehabilitation in a hemiparetic person, who may have trace

muscle activity, possibly little strength, and minimal control, is particularly complicated.

Therefore, a composite of standard plus novel quantitative measures will be used. The functional

inventory will include standard arm assessment scores listed above, and will provide quantifiable

outcomes. Additionally, the MKI method will be used. One quantitative measure we have

developed is myokinetic activity of the extrinsic hand muscles in the forearm, as measured by the

sensor sleeve. In some cases, an index based on muscular performance relative to the sound arm

can be useful. Thus the ratio of peak muscular efforts attained by the affected and sound arms,

respectively can be expressed as, Hi, for each movement, i, calculated as:

where Ai and Si represent muscular effort by the affected and sound limbs for movement i,

respectively. Note that peak muscular effort for particular movements can be estimated by

summing selected forces registered by the sensor sleeve. For example, finger extension effort can

be estimated by myokinetic activity primarily on the posterior forearm. Similar ratiometric

indices will be obtained for all measures, where possible, i.e. goniometric flexion angles of the

joints. We will compare initial and final values of all parameters and will attempt to correlate the

MKI indices with standardized scores of muscle function, and with video and goniometric

measurements. One reason for normalizing measures against the sound limb is to account for

longitudinal changes in overall health or performance, although our results from Phase I indicate

that the measures are not always straightforward and need careful interpretation. For example,

increases in MKI may not reflect advances in motor control, but rather increases in overall non-

specific (i.e. synergistic) muscular effort.

Outcome measures will be analyzed statistically using methods such as ANOVA and t-

test to determine significance, with consultation of a biostatistician within the Rutgers University

Department of Statistics.

H i

A i

S i

Page 25

iii. B. Timeline

Summary

The flowchart below summarizes the project. HARI will be a versatile research and training

tool that providers can use or send home with their clients, and maintain communication through

it regarding compliance and progress. Note that the inputs compose an excellent and well

prepared team, whose institutional affiliations will provide the needed resources and access to

suitable subjects. The activities are straightforward extensions of ongoing work by the company

and outputs are achievable within (See timeline on above). The utility of the project addresses

urgent needs of the population. Outcomes are the objective measures as described earlier.

CAD drawings of

MAST Modifications

Modify and assemble

MAST

Recruit Stroke

Subjects

Exhibit HARI at

Meetings: PT & OT

I II III IV V VI VII VIII

Design review and

Update

Task

Quarters

Form Licensing and

Partnering

24 subjects tested in 3 groups of 8

Program Dextra

Assemble HARI

Contract for Dextra

production

3 month test cycles

with Subjects

Compile Data and

Report

Obtain Funding for

Phase III

Page 26

Management:

Experienced PI

--3 Biomedical

Engineers expert in

man/machine

interface,

robotics, signal

processing.

Neuro-rehabilitation

clinicians/scientists

with stroke/TBI

expertise

--Consultants:

Programmer,

biostatistician,

Physical Therapist

Orthotist

Resources:

--VA , Rutgers,

UMDNJ and Kessler

Rehabilitation

Centers

Orthotic fabrication --

Electronic Hardware

--Motion analysis

Inputs:

Activities: Outputs: Utility:

Short-term

Outcomes

1. HARI trials with

stroke subjects

complete.

2. Relative

efficacy of rehab

protocols

established with

function tests.

3.

Commercialization

1. Modify 3D arm

orthosis (MAST)

with 4 dofs

2.Streamline

manufacture

3. Computer

interface, displays,

4. Training protocols

for shoulder, elbow

and hand, with

HARI.

5. Preparing final

product with

manufacturers and

marketers.

1. Training devices

for shoulder, elbow

and hand

using biofeedback

and progressive

protocols.

2. Assistive Device:

Control of cursor for

tasks and gaming.

3.Monitoring &

Assessment

--M.D.s, PTs, and

OTs can prescribe

protocols that can be

monitored for

compliance and

objective

performance.

1. Versatile 3D arm

reaching tracker

and orthosis:HARI

2.Self-applied

Biofeedback

system.

3. Data on

rehabilitation

efficacy

4. Interface

Software and

hardware

--Robust movement

discrimination.

Long-term

Outcomes1. Target Population

expanded to all with arm

paresis and amputees.

2. Both home and clinic

versions of HARI.

3. Quantifiable recovery of

dexterity.

4. Measure performance

against 'gold standards.'

5. Design similar

rehabilitators for leg and

ankle.

Page 27

1. Association, A.H., Heart Disease and Stroke Statistics-2004 Update.

www.americanheart.org, 2004.

2. Platz, T., S. Bock, and K. Prass, Reduced skilfulness of arm motor behaviour

among motor stroke patients with good clinical recovery: does it indicate reduced

automaticity? Can it be improved by unilateral or bilateral training? A kinematic

motion analysis study. Neuropsychologia, 2001. 39(7): p. 687-698.

3. Butefisch C, H.H., Denzler P, Mauritz Kh, Repetitive Training Of Isolated

Movements Improves The Outcome Of Motor Rehabilitation Of The Centrally

Paretic Hand. J. Neurol. Sci., 1995. 130: p. 59-68.

4. Whitall J, W.S., Silver KHC, Macko RF, Repetitive bilateral arm training with

rhythmic auditory cueing improves motor function in chronic hemiparetic stroke.

Stroke, 2000. 31: p. 2390-2395.

5. Sterr A, F.S., Voss A, Exploring a repetitive training regime for upper limb

hemiparesis in an in-patient setting: a report on three case studies. Brain Inj.,

2002. 16: p. 1093-1107.

6. van der Lee JH, S.I., Beckerman H, Lankhorst, GJ, Wagenaar RC, Bouter LM,

Exercise therapy for arm function in stroke patients: a systematic review of

randomized controlled trials. Clin. Rehabil., 2001. 15: p. 20-31.

7. Platz T, W.T., Muller N, Pinkowski C, Eickhof C, Mauritz KH, Arm ability

training for stroke and traumatic brain injury patients with mild arm paresis: A

single-blind, randomized, controlled trial. Arch. Phys. Med. Rehabil., 2001. 82: p.

961-968.

8. Bourbonnais D, B.S., Lepage Y, Beaudoin N, Gravel D, Forget R, Effect of force-

feedback treatments in patients with chronic motor deficits after a stroke. Am. J.

Phys. Med. Rehabil., 2002. 81: p. 890-897.

9. Turton A, P.V., When should upper limb function be trained after stroke?

Evidence for and against early intervention. Neurorehabilitation, 2002. 17: p.

215-224.

10. Wolf SL, B.S., Baer H, Breshears, Butler AJ, Repetitive task practice: A critical

review of constraint- induced movement therapy in stroke. Neurologist, 2002.

8(14): p. 325-338.

11. Page SJ, S.S., Levine P, Modified constraint-induced therapy in chronic stroke.

Am. J. Phys. Med. Rehabil., 2002. 81: p. 870-875.

12. Page SJ, L.P., Sisto SA, Johnston, MV, Mental practice combined with physical

practice for upper-limb motor deficit in subacute stroke. Phys.Ther, 2001. 81: p.

1455-1462.

13. Reinkensmeyer DJ, T.C., Timoszyk WK, Reinkensmeyer AN, Kahn LE, Design

of robot assistance for arm movement therapy following stroke. Advanced

Robotics, 2000. 14(7): p. 625-637.

14. Reinkensmeyer DJ, K.L., Averbuch M, McKenna-Cole A, Schmit BD, Rymer

WZ, Understanding and treating arm movement impairment after chronic brain

injury: Progress with the ARM guide. Journal Of Rehabilitation Research And

Development, 2000. 37(6): p. 653-662.

Page 28

15. Scheidt RA, R.D., Conditt MA, Rymer WZ, Mussa-Ivaldi FA, Persistence of

motor adaptation during constrained, multi-joint, arm movements. Journal Of

Neurophysiology, 2000. 84(2): p. 853-862.

16. Lum PS, B.C., Shor PC, Majmundar M, Van der Loos, M, Robot-assisted

movement training compared with conventional therapy techniques for the

rehabilitation of upper-limb motor function after stroke. Arch. Phys. Med.

Rehabil., 2002. 83: p. 952-959.

17. Volpe BT, K.H., Hogan N, Edelstein L Diels, C Aisen, M, A novel approach to

stroke rehabilitation-robot-aided sensorimotor stimulation. Neurol., 2000. 54: p.

1938-1944.

18. Volpe BT, K.H., Hogan N, Is robot-aided sensorimotor training in stroke

rehabilitation a realistic option? Curr. Opin. Neurol, 2001. 14: p. 745-752.

19. Popovic DB, P.M., Sinkjaer T, Neurorehabilitation of upper extremities in

humans with sensory-motor impairment. Neuromodulation, 2002. 5: p. 54-67.

20. Landau WM, S.S., Preservation of directly stimulated muscle strength in

hemiplegia due to stroke. Arch. Neurol., 2002. 59: p. 1453-1457.

21. Kwakkel G, K.B., Wagenaar RC, Long term effects of intensity of upper and

lower limb training after stroke: a randomised trial. J. Neurol. Neurosurg.

Psychiatry, 2002. 72: p. 473- 479.

22. Merians AS, J.D., Boiau R, Tremaine M, Burdea GC, Adamovich SV, Recce, M,

Poizner H, Virtual reality-augmented rehabilitation for patients following stroke.

Phys. Ther, 2002. 82: p. 898-915.

23. Carey JR, K.T., Lewis SM, Auerbach EJ, Dorsey L, Rundquist P, Ugurbil, K,

Analysis of fMRI and finger tracking training in subjects with chronic stroke.

Brain, 2002. 125: p. 773-788.

24. Brain, W.R.B. and M. Donaghy, Brain's diseases of the nervous system. 11th ed.

2001, Oxford ; New York: Oxford University Press. xviii, 1242 p., [8] p. of

plates.

25. Damiano, D.L., K. Dodd, and N.F. Taylor, Should we be testing and training

muscle strength in cerebral palsy? Dev Med Child Neurol, 2002. 44(1): p. 68-72.

26. Mirbagheri, M.M., H. Barbeau, and R.E. Kearney, Intrinsic and reflex

contributions to human ankle stiffness: variation with activation level and

position. Experimental brain research. Experimentelle Hirnforschung, 2000.

135(4): p. 423-36.

27. Galiana, L., J. Fung, and R. Kearney, Identification of intrinsic and reflex ankle

stiffness components in stroke patients. Experimental brain research.

Experimentelle Hirnforschung, 2005. 165(4): p. 422-34.

28. Cirstea, M.C., A. Ptito, and M.F. Levin, Arm reaching improvements with short-

term practice depend on the severity of the motor deficit in stroke. Experimental

Brain Research, 2003. 152(4): p. 476-88.

29. Feys, H., et al., Early and repetitive stimulation of the arm can substantially

improve the long-term outcome after stroke: a 5-year follow-up study of a

randomized trial. Stroke, 2004. 35(4): p. 924-9.

30. Feys, H.M., et al., Effect of a therapeutic intervention for the hemiplegic upper

limb in the acute phase after stroke - A single-blind, randomized, controlled

multicenter trial. Stroke, 1998. 29(4): p. 785-792.

Page 29

31. Krebs, H.I., et al., Rehabilitation robotics: Performance-based progressive robot-

assisted therapy. Autonomous Robots, 2003. 15(1): p. 7-20.

32. Parry, R.H., N.B. Lincoln, and C.D. Vass, Effect of severity of arm impairment on

response to additional physiotherapy early after stroke. Clinical Rehabilitation,

1999. 13(3): p. 187-198.

33. Platz, T., Evidence-based arm rehabilitation - a systematic review of the

literature. Nervenarzt, 2003. 74(10): p. 841-+.

34. Taub, E., G. Uswatte, and R. Pidikiti, Constraint-Induced Movement Therapy: A

new family of techniques with broad application to physical rehabilitation - A

clinical review. Journal of Rehabilitation Research and Development, 1999.

36(3): p. 237-251.

35. Woldag, H., et al., Is the repetitive training of complex hand and arm movements

beneficial for motor recovery in stroke patients? Clinical Rehabilitation, 2003.

17(7): p. 723-730.

36. Mindel, C., Technical Assistance Guide for NIDRR Grantees and Applicants.

www.ed.gov, 2003.

37. Abernethy, B., Chapter 11: Physiological Adaptations to Training, in The

biophysical foundations of human movement. 2005, Human Kinetics: Champaign,

IL. p. xi, 363 p.

38. Abernethy, B., Chapter 9: Biomechanical Adaptations to Training, in The

biophysical foundations of human movement. 2005, Human Kinetics: Champaign,

IL. p. xi, 363 p.

39. Ketelaar, M., et al., Effects of a functional therapy program on motor abilities of

children with cerebral palsy. Phys Ther, 2001. 81(9): p. 1534-45.

40. Seymour, R., Prosthetics and orthotics : lower limb and spinal. 2002,

Philadelphia: Lippincott Williams & Wilkins. xiv, 485 p.

41. Wolf, S.I., Efficacy of Electromyographic Biofeedback Compared with

Conventional Physical Therapy for Upper-Extremity Function in Patients

Following Stroke - a Research Overview and Metaanalysis - Invited Commentary.

Physical Therapy, 1994. 74(6): p. 544-545.

42. van Dijk, H. and H.J. Hermens, Distance training for the restoration of motor

function. Journal of Telemedicine and Telecare, 2004. 10(2): p. 63-71.

43. Ernst, E., Systematic reviews of biofeedback. Physikalische Medizin

Rehabilitationsmedizin Kurortmedizin, 2003. 13(6): p. 321-324.

44. Armagan, O., F. Tascioglu, and C. Oner, Electromyographic biofeedback in the

treatment of the hemiplegic hand: a placebo-controlled study. American Journal

of Physical Medicine & Rehabilitation, 2003. 82(11): p. 856-61.

45. Aichner, F., C. Adelwohrer, and H.P. Haring, Rehabilitation approaches to

stroke. Journal of Neural Transmission-Supplement, 2002(63): p. 59-73.

46. Giaquinto, S., M. Mascio, and L. Fraioli, The physiopathological bases of

recovery processes: The bases of stroke rehabilitation. The CASSINO project.

Clinical and Experimental Hypertension, 2002. 24(7-8): p. 543-553.

47. Glanz, M., S. Klawansky, and T. Chalmers, Biofeedback therapy in stroke

rehabilitation: a review. Journal of the Royal Society of Medicine, 1997. 90(1): p.

33-39.

Page 30

48. Glanz, M., et al., Biofeedback Therapy in Poststroke Rehabilitation - a

Metaanalysis of the Randomized Controlled Trials. Archives of Physical

Medicine and Rehabilitation, 1995. 76(6): p. 508-515.

49. Moreland, J. and M.A. Thomson, Efficacy of Electromyographic Biofeedback

Compared with Conventional Physical Therapy for Upper-Extremity Function in

Patients Following Stroke - a Research Overview and Metaanalysis. Physical

Therapy, 1994. 74(6): p. 534-547.

50. Reddy, N.P., et al., Biofeedback therapy using accelerometry for treating

dysphagic patients with poor laryngeal elevation: case studies. Journal of

Rehabilitation Research and Development, 2000. 37(3): p. 361-372.

51. Richards, L. and P. Pohl, Therapeutic interventions to improve upper extremity

recovery and function. Clinics in Geriatric Medicine, 1999. 15(4): p. 819-+.

52. Rudd, A., National Clinical Guidelines for Stroke: a concise update. Clinical

Medicine, 2002. 2(3): p. 231-233.

53. Shepherd, R., Electromyographic biofeedback following stroke slightly increases

ankle dorsiflexion strength but not ankle range - Commentary. Australian Journal

of Physiotherapy, 1999. 45(1): p. 47-47.

54. Sukthankar, S.M., et al., Design and Development of Portable Biofeedback

Systems for Use in Oral Dysphagia Rehabilitation. Medical Engineering &

Physics, 1994. 16(5): p. 430-435.

55. Taly, A.B. and B.H. Dobkin, Motor Recovery and Therapeutic Interventions.

Neurology India, 1995. 43(1): p. 1-10.

56. van der Lee, J.H., et al., Exercise therapy for arm function in stroke patients: a

systematic review of randomized controlled trials. Clinical Rehabilitation, 2001.

15(1): p. 20-31.

57. Walker, C., B.J. Brouwer, and E.G. Culham, Use of visual feedback in retraining

balance following acute stroke. Physical Therapy, 2000. 80(9): p. 886-895.

58. Wolf, S.L., et al., Overcoming Limitations in Elbow Movement in the Presence of

Antagonist Hyperactivity. Physical Therapy, 1994. 74(9): p. 826-835.

59. Zorowitz, R.D., Neurorehabilitation of the stroke survivor. Neurorehabilitation

and Neural Repair, 1999. 13(2): p. 83-92.

60. Dursun, E., N. Dursun, and D. Alican, Effects of biofeedback treatment on gait in

children with cerebral palsy. Disabil Rehabil, 2004. 26(2): p. 116-20.

61. Lyons, G.M., et al. A computer game-based EMG biofeedback system for muscle

rehabilitation. in Engineering in Medicine and Biology Society, 2003.

Proceedings of the 25th Annual International Conference of the IEEE. 2003.

62. Rampa, M., Exploring your Rehab options: Neuromuscular biofeedback. Stroke

Smart, 2003(July/August): p. 23-25.

63. Peckham, P.H. and J.S. Knutson, Functional electrical stimulation for

neuromuscular applications. Annu Rev Biomed Eng, 2005. 7: p. 327-60.

64. Hsueh, I.H., CL, TI Responsiveness of two upper extremity function instruments

for stroke inpatients receiving rehabilitation. Clin. Rehabil., 2002. 16: p. 617 -

624.

65. Light CM, C.P., Kyberd PJ, Establishing a standardized clinical assessment tool

of pathologic and prosthetic hand function: Normative data, reliability, and

Page 31

validity. Archives of Physical Medicine and Rehabilitation, 2002. 83(6): p. 776-

783.

66. Girone, M., et al., A Stewart Platform-Based System for Ankle Telerehabilitation.

Autonomous Robots, 2001. 10(2): p. 203-212.

67. Teulings, H.L., et al., Parkinsonism reduces coordination of fingers, wrist, and

arm in fine motor control. Experimental neurology, 1997. 146(1): p. 159-70.

68. Morris, T., et al. Quantifying Ankle Motion Using The Ankle-Foot Interface (AFI).

in 12th World Congress of The International Society for Prosthetics and

Orthotics. 2007. Vancouver, BC Canada.

69. Curcie, D.J., J.A. Flint, and W. Craelius, Biomimetic finger control by filtering of

distributed forelimb pressures. IEEE Trans Neural Syst Rehabil Eng, 2001. 9(1):

p. 69-75.