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This Issue High School Knee Study ...................... 2 TBI Study ............................................ 2 Manual Therapy for Neck .................... 3 Falls Prevention .................................... 3 LEAPS Update ..................................... 4 Care Tool Update ................................. 4 Advanced Wound Care......................... 5 Brooks Research Day ........................... 6 Brooks Active Clinical Trials ................. 6 Educational and Clinical News F or the past 10 years, Brooks has worked with the Brain Rehabilitation Research Center (BRRC) in Gainesville, Fla. to conduct research that will enable us to learn more about the effects of neurological injuries or diseases and to develop new forms of treatment that may improve function and quality of life for Brooks patients. The BRRC began conducting screenings in August at the Brooks Center, and will continue once a month in an effort to determine if a patient is eligible for a study, to recruit participants and to offer clinical trial participation to Brooks patients and the Jacksonville community. Screenings will take place in the Brooks Center lab located at 3901 University Blvd. South, Suite 101, the last Thursday of each month. In the past, the screening process was only available in Gainesville and therefore unavailable to those that could not travel to that site. By bringing the BRRC screening to Jacksonville, more individuals will know their eligibility for existing trials. Also, the potential to offer research trials in the Jacksonville area will become more evident to those investigators seeking multi-site funding. The BRRC is located at the Malcom Randall Veteran’s Administration Center, a VA Center of Excellence. Both veterans and non-veterans are eligible to participate in VA- sponsored research. The research leadership of the BRRC is comprised of nationally and internationally recognized investigators many of whom have dual appointments with the University of Florida and the Veteran’s Administration. The Brooks Center has collaborated to recruit, screen and enroll patients in rehabilitation research trials in both the Jacksonville and Gainesville centers. To date, we have collaborated on numerous trials in the areas of motor and language recovery after stroke. The Brooks Center has been a data collection site for eight BRRC-sponsored research trials over the past 10 years. More than 100 participants have been enrolled for either the screening or treatment studies as a result of our referral process. Brain Rehabilitation Research Center to Conduct Screenings at the Brooks Center for Rehabilitation Studies VOL 4/ISS 2 • Fall 2009 If you or a family member would like any additional information about this screening for potential research trial participation, please call Floris Singletary at (904) 306-8973.

Innovations Fall 09

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or the past 10 years, Brooks has worked with the Brain Rehabilitation Research Center (BRRC) in Gainesville, Fla. to conduct research that will enable us to learn more about the effects of neurological injuries or diseases and to develop new forms of treatment that may improve function and quality of life for Brooks patients. Advanced Wound Care .........................5 Brooks Research Day ...........................6 Brooks Active Clinical Trials .................6 VOL 4/ISS 2 • Fall 2009

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Page 1: Innovations Fall 09

This IssueHigh School Knee Study ......................2TBI Study ............................................2Manual Therapy for Neck ....................3

Falls Prevention ....................................3LEAPS Update .....................................4Care Tool Update .................................4

Advanced Wound Care .........................5Brooks Research Day ...........................6Brooks Active Clinical Trials .................6

Educational and Clinical News

For the past 10 years, Brooks has worked with the Brain Rehabilitation Research Center (BRRC) in Gainesville, Fla. to conduct research that will enable us to learn more

about the effects of neurological injuries or diseases and to develop new forms of treatment that may improve function and quality of life for Brooks patients.

The BRRC began conducting screenings in August at the Brooks Center, and will continue once a month in an effort to determine if a patient is eligible for a study, to recruit participants and to offer clinical trial participation to Brooks patients and the Jacksonville community. Screenings will take place in the Brooks Center lab located at 3901 University Blvd. South, Suite 101, the last Thursday of each month.

In the past, the screening process was only available in Gainesville and therefore unavailable to those that could not travel to that site. By bringing the BRRC screening to Jacksonville, more individuals will know their eligibility for existing trials. Also, the potential to offer research trials in the Jacksonville area will become more evident to those investigators seeking multi-site funding.

The BRRC is located at the Malcom Randall Veteran’s Administration Center, a VA Center of Excellence. Both veterans and non-veterans are eligible to participate in VA-sponsored research. The research leadership of the BRRC is comprised of nationally and internationally recognized investigators many of whom have dual appointments with the University of Florida and the Veteran’s Administration.

The Brooks Center has collaborated to recruit, screen and enroll patients in rehabilitation research trials in both the Jacksonville and Gainesville centers. To date, we have collaborated on numerous trials in the areas of motor and language recovery after stroke. The Brooks Center has been a data collection site for eight BRRC-sponsored research trials over the past 10 years. More than 100 participants have been enrolled for either the screening or treatment studies as a result of our referral process.

Brain Rehabilitation Research Center to

Conduct Screenings at the Brooks Center for Rehabilitation Studies

VOL 4/ISS 2 • Fa l l 2009

If you or a family member would like any additional information about this screening for potential research trial participation, please call Floris Singletary at (904) 306-8973.

Page 2: Innovations Fall 09

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In May 2009, a team from the University of North Florida and Brooks Center for Sports Therapy began enrolling high school athletes in a research study titled, “Assessment of Proposed

Risk Factors for Knee Injuries in High School Male and Female Athletes.” The purpose of this study is to assess the differences in movement patterns between male and female athletes and their risk factors for knee injuries.

In only three months, 100 student-athletes from Nease High School and Ponte Vedra High School have been enrolled in this study. The investigators will follow the student-athletes through the fall, winter and spring sports seasons to assess those who sustain a knee injury. Michelle Boling, Ph.D., LAT, ATC, Assistant Professor in the Department of Clinical and Applied Movement Sciences at the University of North Florida and Rob Coltman, PT, MPT, OCS, Center Manager at Brooks Center for Sports Therapy, are collaborating on this project.

The idea for this study came from Boling and Coltman’s strong interest in understanding the risk factors for common acute and chronic knee injuries. The two injuries they are most interested in are patellofemoral pain syndrome and anterior cruciate ligament (ACL) injuries. Patellofemoral pain syndrome is a chronic knee injury that presents itself with pain behind and around the kneecap (patella). The ACL is one of two ligaments located in the center of

the knee that acts to stabilize the knee during dynamic movements. Injury to the ACL and the development of patellofemoral pain syndrome can be debilitating for physically active young adults so it is very important to understand the risk factors that may be leading to these injuries. Furthermore, females are reported to have a higher occurrence of patellofemoral pain syndrome and ACL injury compared to males, so it is important to try to understand why this gender difference exists. This investigation will attempt to provide an answer to this question by evaluating the movement patterns of male and female student-athletes during a jumping and squatting task. Additionally, the investigators will prospectively follow participants to determine the biomechanical risk factors for patellofemoral pain syndrome and ACL injury.

If you would like more information on this study, please contact the Principal Investigator, Michelle Boling, Ph.D., LAT, ATC at (904) 620-1563 or [email protected]

100 High School

Athletes Enrolled in New Study

Brooks Rehabilitation

Remains a Top Recruiter for TBI-PBE Study

Brooks Rehabilitation is one of 10 facilities across the nation and Canada involved in the Traumatic Brain Injury-Practice Based Evidence (TBI-PBE) study, which includes four

Model Systems of Care. After only 10 months, 75 participants have been enrolled in this study. At an enrollment rate of 82 percent we remain one of the top three facilities for patient enrollment.

This study focuses on improving outcomes and care of patients who have experienced a traumatic brain injury. The researchers are trying to determine the most effective treatments in inpatient rehabilitation. The TBI-PBE is compromised of four major goals: 1) Identify patient and injury characteristics including co-morbidities and complications that contribute to variations in outcome; 2) Identify medical procedures and therapy interventions associated with better outcomes; 3) Determine whether or not specific impairment by therapy interactions are associated with better outcomes; 4) Determine the individual differences in demographic characteristics, pre-morbid status, injury-related conditions and medical course that differentially predict the effectiveness

of rehabilitation interventions on functional independence, participation and subjective well-being up to one year following TBI.

The study is the first ever National Institutes of Health (NIH) grant awarded in the field of rehabilitation for a study of this kind. In addition, the study has also received a parallel five-year grant from the National Institute on Disability and Rehabilitation Research (NIDRR) to follow enrolled patients up to one year following injury. The purpose of both grants is focused on improving care and outcome of patients who have sustained a traumatic brain injury. Researchers are trying to find out what works and what doesn’t work in inpatient rehabilitation and across the one-year recovery continuum.

If you would like more information on the study please contact Dr. Cynthia Beaulieu at (904) 345-7651 or [email protected]. Only patients admitted to BRH during the acute recovery stage are eligible for enrollment in this study.

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Manual therapy is a commonly used intervention for the management of spinal disorders and familiar to most

physical therapists. Recent research has indicated manual therapy for management of patients with neck and low back pain is effective. A new study at Brooks titled “Immediate Effects on Sensation Perception following Manual Therapy Interventions to the Thoracic Spine” will examine the local effects following a manual therapy intervention.

The neurophysiologic mechanisms of one type of manual therapy, spinal manipulative therapy (SMT), have been suggested to involve inhibition of activity at the level of the spinal cord. This current study is attempting to identify if there is an immediate local hypoanalgesic effect (via thermal and mechanical sensation testing) associated with a cervical region manual therapy.

The investigators are also looking to identify if there is a difference in immediate local hypoanalgesic effects based on treatment (SMT vs. specific exercise). Finally, the team wants to identify if any psychological factors influence outcomes via self-report questionnaires.

The research team is hoping to enroll 100 subjects in this study. Participants will be given $20 as compensation for their time. Patients will be tested at University of Florida in Gainesville and at the Brooks Center for Rehabilitation Studies in Jacksonville.

To enroll in this study participants must be between 18-35 years of age and have no neck or upper-extremity complaints within the past 60 days. Participants will not be included in the study if they have any medical signs suggesting systemic dysfunction or have a history of whiplash-type injury within the past 60 days. Participants will also be excluded from the study if they have previous spinal or upper-extremity surgical interventions or use of analgesic or anti-inflammatory drugs regularly. Once accepted into the study, participants will be randomly assigned to one of three groups: 1) SMT, 2) Specific Cervical Exercise (SCE) or, 3) control group (the control group will not receive any treatment).

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Positive Results Found in Study Looking at Preventing Falls in the Elderly

Fourteen participants from the Jacksonville area have been enrolled in a new study funded by the Brooks Endowment Fund hoping to decrease falls in the elderly. The study, titled

“Psychosocial Factors Influence on Response to Falls Intervention Program in Older Adults,” aims to discover how individual attitudes and thoughts, such as fear, might affect the changes a person experiences during intervention for a balance program.

During a recent presentation at Brooks Research Seminar Series, Dr. Mark Bishop, shared information with Brooks’ employees about the prevalence of falls in the United States, psychosocial factors that influence falls and this new study.

“All of the patients enrolled in this study have made improvements in their clinical balance,” Bishop said.

New Study to Assess Manual Therapy for the Neck

THE RESEARCH TEAM FOR THIS STUDY INCLUDES:

• Mark Bishop, PT, Ph.D. Principal Investigator, University of Florida

• Steven George, PT, Ph.D. University of Florida

• Jason Beneciuk, DPT University of Florida Doctoral Student and Brooks Rehabilitation

• Robert Rowe, DPT, MHS Brooks Rehabilitation

• Russell Smith, PT, EdD University of North Florida

For more information or to enroll in this study, please contact: Mark Bishop, PT, Ph.D., Assistant Professor Department of Physical Therapy at (352) 273-6112 or [email protected].

Continued on page 5...

Page 4: Innovations Fall 09

LEAPS Exceeds its Goal of 400 Patients

Brooks Rehabilitation Hospital is near the

final stages of a national study collecting patient data for the Centers for Medicare and Medicaid Services that will likely impact future health care reform decisions.

The study will produce a tool that should assist facilities in consistently determining the most

appropriate post acute setting/level of care for patients and ultimately the best outcome with the most efficient utilization of services.

The Medicare Post Acute Care Payment Reform Demonstration provides patient data from the Inpatient Stroke and Inpatient Orthopedic programs. The goal of this initiative is to discover the best way to standardize patient assessment information from Post Acute Care (PAC) settings and to use these data to guide payment policy in the Medicare program, according to Research Triangle Institute, International (RTI), the CMS-contracted organization

collecting data for the initiative. PAC settings refer to Long Term Care Hospitals (LTCHs), Inpatient Rehabilitation Facilities (IRFs), Skilled Nursing Facilities (SNFs) and Home Health Agencies (HHAs).

Since September 2008, Brooks Inpatient Orthopedic and Stroke Program staff have assessed about 350 patients through the Care Tool process, which wields about 700 assessments, since patients are assessed at admission and discharge at Brooks.

Noel Miller, Orthopedic Program Director at Brooks Rehabilitation Hospital, has been heading the effort along with the Brooks site CARE Tool Coordinator Shawn Witherspoon, Orthopedic Program PT. Miller said Brooks has been one of the largest participants nationally, and that RTI will have data from the study ready in 2010 & it will be presented to congress in 2011.

Utilizing the Care Tool as a patient assessment instrument, clinicians in acute and post acute care settings will be able to determine the best level of care for a patient and the amount of resources needed for their rehabilitation.

Miller also said she will be participating in the American Medical Rehabilitation Providers Association’s conference in October alongside RTI’s Barbara Gage and other participating facility leaders to provide feedback regarding “Lessons Learned” from this large demonstration project.

Brooks Wraps Up Care Tool Study

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In May 2009, the Locomotor Experience Applied Post-Stroke (LEAPS) study finished its participant recruitment and exceeded its goal of 400 patients. This study, which began three years ago

in June 2006, enrolled a total of 408 individuals post-stroke. Five sites in the United States participated in this project: two in Florida and three in California. The Brooks Rehabilitation LEAPS team contributed greatly to the study by enrolling 96 total individuals.

The LEAPS trial is the largest rehabilitation research study funded by the National Institute of Health (NIH) to date. The two main purposes of the trial are to determine when to begin physical therapy and the effectiveness of particular therapy methods to improve the ability to walk following a stroke. This randomized trial will assess whether there is a difference in the proportion of subjects who successfully recover the ability to walk, as measured by gait speed – comparing a group that received a locomotor training program using partial body weight support and a treadmill with manual trainers, compared to a group that received a therapist-supervised, home-based, exercise program.

The investigators are examining the effect of timing of therapy delivery on rehabilitation success, such as: 1) whether to intervene early (2 months) or late (6 months) after stroke; 2) stroke severity (moderate versus severe) and; 3) intensity (number of sessions: 12, 24 or 36). In addition to examining the effect of therapy on walking speed, researchers will assess if improvements in walking

speed post-stroke ultimately improves a person’s ability to perform activities of daily living and quality of life.

The LEAPS team has exceeded all of its enrollment goals and anxiously awaits the results of the study, which should be compiled by summer 2010. These findings should guide therapists’ selection of therapies to improve walking-related outcomes of individuals post-stroke. The LEAPS team will be presenting to Brooks staff Nov. 4, 2009 at the First Brooks Research Day.

The LEAPS team would like to thank the following team members and volunteers at Brooks for all of their help and support:

BROOKS LEAPS TEAM

Trevor Paris, MD - Medical Director • Dr. Pam Duncan - Principal Investigator • Dr. Andrea Behrman - Co-Investigator • Dr. Dorian Rose - Co-Investigator and Clinical Coordinator • Joann Gallichio, PT - Team Leader • Molly Dunn, PT - Intervention Therapist • Amanda Ayala - Research Assistant • Jackie Causer - Research Assistant • Brooke Hoisington, PT - Intervention Therapist • Brenda Abercrombie - Volunteer • Ali Wharton - Volunteer • Jeanette Day - Research Assistant • Charles Gay - Volunteer/Research Assistant • Holly Morris - Brooks Research Director • Jodi Morgan - Brooks Clinical Research Liaison • Flo Singletary - Brooks Center Clinical Coordinator • A team of Blinded Assessors and many others.

Miller

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To date, every participant gave a report of feeling at least moderately improved after the study. They also increased their desire to walk and move around, with less fear of falling. Seventy-five percent of the participants have made improvements and positive changes in the amount of daily activity they perform.

Bishop said he believes it is too early to speculate, but the study is showing some positive results early on.

Patients for this study will be accepted throughout the community and will be evaluated at The Brooks Center for Rehabilitation Studies. Eligible participants must be between 60 and 90 years old and have a history of at least two falls in the past year.

Participants are given a full evaluation and a home exercise program, designed specifically for them. The home exercise

program will include strengthening exercises for hips, knees and ankles, and balance exercises like standing on one foot, walking heel-toe, single leg standing, walking forward or backward or picking objects off the floor. Participants must be willing to attend testing sessions once a month for three months. They will be paid $20 after each evaluation, with the potential to earn $80.

The possible benefits of being involved in this study could include an improvement in participants’ strength and balance and an increase in the ability to walk without falling. The study may also help others by improving the design of exercises for strength and balance.

For more information on this study or if you would like to participate please contact Mark Bishop, PT, Ph.D. at (352) 273-6112.

Brooks Home Care Advantage Finds Success in Treating Advanced Wound Care

Brooks Home Care Advantage treats more than 1,500 patients every year with some type of pressure ulcer or wound. Pressure ulcer wounds are very painful for

the patient and can sometimes be very hard to treat. Webster’s New Riverside University Dictionary defines an ulcer as “an inflammatory, often suppurating lesion on the skin or an internal mucosal surface of the body, as in the duodenum, resulting in necrosis of the tissue.” Dorland’s Medical Dictionary describes an ulcer (Latin, ulcus; Greek, heliosis) as “a local defect or excavation on the surface of an organ or tissue produced by sloughing of inflammatory necrotic tissue.”

Standardized measuring techniques are necessary to provide quantitative information on wound healing and to validate research. Brooks Home Care Advantage recently made some changes in the procedures for caring for a wound patient, and exclusively uses Soutions® by ConvaTec. This product provides evidence based processes linking skin and wound characteristics to topical product solutions. Proven algorithms have been devised by ConvaTec when assessing and treating pressure ulcers and wounds.

Brooks Home Care Advantage has seen significant improvement in it’s Wound Care program by implementing this evidence-based protocol for patients. There are many methods of treating pressure ulcers and wounds. Brooks Home Care Advantage has followed the latest research and guidelines so that we are able to offer our patients the best possible care.

In the past wound care patients would need to be seen by a home health professional at least two or three times a day. With the recent changes in home care reimbursement, the way a wound is managed must be changed as well. Moist wound healing has not been widely

accepted despite the wealth of research and data to suggest it is a very effective way both in healing wounds as well as being cost-effective.

It allows us to reduce the number of visits without reducing the quality of Wound Care. Moist wound healing has been proven to dramatically improve the care of a wound, resulting in the implementation of this new protocol. The dated method of using a gauze dressing has actually been proven to show an increase in infections and a longer recovery time. Research has shown that a wet-to-dry gauze dressing is used as a classical mechanical debridement technique, not a healing technique.

Gauze is designed to remove necrotic tissue. Once the necrotic tissue has been removed from the wound, gauze dressings should be discontinued. It is possible and highly likely that the gauze will adhere to the healthy tissue and lead to injury of that healthy tissue resulting in bleeding and more infection, ultimately slowing the healing process and causing more pain for the patient.

Microscopic slides have shown that cotton fibers from gauze can be left in the wound bed and cause a foreign body reaction and a chronic inflammatory state. Patients receiving wet-to-dry dressings take a longer time to heal due to the chronic inflammation from the foreign body reaction.

Brooks Home Care Advantage provides our patients with the latest and most cutting edge procedures and uses only proven evidence-based protocols for healing wounds.

For more information please contact, Brenda Phillips, Manager of Staff Development at (904) 306-9729 or visit our website at brookshomecareadvantage.org.

Preventing Falls in the Elderly, continued from page 3

Page 6: Innovations Fall 09

AUGUST 2009Brooks’ Active Clinical Trials

• 3-3:15 - Presentation of the First Annual Brooks Brown Research Award: Doug Baer, CEO of Brooks and Michael Spigel, COO of Brooks

• 3:15-4:15 - Keynote Speaker: Dr. Gerben DeJong, “Health Care Reform: Implications for Post-acute Care and Research”

Brooks Neuro/Ortho Residency Case Study #1

• 4:30-5:30 - Dr. Jeffrey Kleim,“Neural Plasticity and Rehabilitation. The Brain Can Bounce Back!”

Brooks Neuro/Ortho Residency Case Study #2

• 6-7:00 - Dr. Pam Duncan and LEAPS Team, “The Locomotor Experience Applied Post-Stroke Trial: Added Clinical Value from the Process, While We Await the Outcomes”

Brooks Neuro/Ortho Residency Case Study #3

• 7:15-8:00 - Dr. Pam Chally, “Spirituality and Spinal Cord Injury. What We Can Learn From Our Patients”

CEUs will be available for all disciplines. You can attend one or all of the courses offered. Please call Jodi Morgan for more details at (904) 306-8970. Register through Brooks University.

The Brooks Rehabilitation Research Day is scheduled to take place Wednesday, Nov. 4th, 2009 in Assembly room 1 and 2 in the new Brooks administration building. This day is designed to promote awareness and enthusiasm within Brooks about research and its application to clinical practice. The event will also provide high caliber educational opportunities for Brooks’ clinicians and employees.

We are also showcasing all the fantastic work being done within our research community. If you are a Brooks employee come join us for an incredible day filled with stimulating presentations, posters and discussions on the latest in rehabilitation research. Learn more about all the Brooks research projects. Meet some of the investigators and the research staff.

Brooks Rehabilitation Research Day

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Stroke:

#131-2007: Developing a Computer Adaptive Functional Cognitive Measure in StrokePurpose: To develop a way to measure cognitive skills of acute and chronic stroke patients using adaptive computer technology.Study phase: Data AnalysisPrincipal Investigator: Craig Velozo, Ph.D., (352) 273-6128 or [email protected] Enrollment Criteria: Participants must have had a stroke within the past 12 months and must have a caregiver or friend participate with them.

#262-2005: Locomotor Experience Applied Post Stroke (LEAPS)Purpose: To compare two different treatment interventions to improve walking after stroke.Study phase: Data AnalysisPrincipal Investigator: Pam Duncan, Ph.D., (919) 286-3399 ext. 239Enrollment Criteria: Participants must be screened within 45 days of stroke. They may be screened at Brooks Rehabilitation Hospital, referred by clinicians within the community or self referred. leaps.org

#H501-2006: Matching the Needs of Stroke Patients with Caregiving Resources to Improve OutcomesPurpose: To develop a decision making tool to target potential issues prior to patient discharge from a facility.

Study phase: Data Analysis Principal Investigator: Barbara Lutz, RN, Ph.D., (352) 273-6350 or [email protected] Criteria: Patient must have an inpatient rehabilitation stay at Brooks Rehabilitation Hospital. There also must be a caregiver involved.

#472-2001: Treating Intention in Aphasia: Neuroplastic SubstratesPurpose: To develop a treatment for increasing language function in non-fluent aphasia.Study phase: Active enrollment through September 2009Principal Investigator: Bruce Crosson, Ph.D., (352) 376-1611 ext 5329Enrollment Criteria: Participants must be greater than 6 months post onset of stroke and have difficulty communicating. Must be right handed prior to stroke and cannot have a history of seizures.

#06-00551300: The Brain Hemorrhage Cognitive Recovery StudyPurpose: To establish a natural history of cognitive recovery in survivors of spontaneous and warfarin-associated ICH and compare the cognitive recovery to that observed in ischemic subtypes of stroke. Study phase: Data analysisCo-Principal Investigators: Thomas Brott, M.D,. Trevor Paris, M.D., and Beth Rush Ph.D., (904) 953-7286 or [email protected] Enrollment Criteria: Participants must have experienced an ischemic stroke or intracerebral hemorrhage and must be admitted to Brooks

Dr. Gerben DeJong - Keynote Speaker

Heavy Hors d’oevres will be served.

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Rehabilitation Hospital within the first 3 weeks post onset. Also looking for volunteers from the community who are “stroke free.”

#335-2007: Translating Motor Learning and Neural Plasticity Principles to Stroke Care at Brooks Rehabilitation Hospital: From Efficacy to EffectivenessPurpose: To translate principles of neural plasticity and motor learning into the stroke program of care at Brooks Rehabilitation Hospital. Practice is the known strongest variable for motor learning to occur and task-related practice is advocated during stroke rehabilitation to improve functional performance of daily activities. Concordant studies of neural plasticity indicate that repetition of a newly learned (or relearned) movement sequence is required to induce lasting neural changes.Study Phase: Data AnalysisPrincipal Investigator: Trevor Paris, M.D., (904) 345-7602 or [email protected] Enrollment Criteria: Participants must have had a CVA and be admitted to Brooks Rehabilitation Hospital Stroke Program.

#2005-054: Insulin Resistance Intervention After Stroke (IRIS) TrialPurpose: The purpose of this study is to see if a new treatment (pioglitazone) will prevent future strokes and heart attacks among persons with a recent stroke or transient ischemic attack (TIA).Study Phase: Active enrollment through December 2009Principal Investigator: Scott Silliman, M.D., (904) 244-9945 or [email protected] Criteria: Participants must have had a stroke or TIA within the past 180 days and cannot be diabetic or taking any insulin related medications.

#2007-044: Late Development of Epileptiform Activity on Electroencephalography in Cerebral Cortical InfarctionPurpose: The purpose of this study is to identify the percentage of patients with a history of stroke that later develop changes on an electroencephalogram (EEG), a study that records brain waves, which could be a risk for developing seizures. Study Phase: Active EnrollmentPrincipal Investigator: Nader Antonios, M.D., (904) 244-9514Enrollment Criteria: Participants must have had a stroke between 6 months and 5 years ago.

#422-2008: Mechanisms of Restoring Gait Post-Stroke: Role of the Ankle PlantarflexorsPurpose: The purpose of this research program is to develop and evaluate evidenced-based therapeutic interventions that promote restitution of impairments that will maximize functional outcomes post-stroke. The specific objective of this application is to evaluate a targeted plantar flexor strengthening program on the restitution of the paretic limb contribution to gait.Study Phase: Active Enrollment – Brooks Health Care Plaza onlyPrincipal Investigator: Dorian K. Rose, Ph.D., PT, (352) 273-8307 or [email protected] Enrollment Criteria: Participants must have had a stroke within the past 6 months and referred to the Brooks Health Care Plaza for outpatient physical therapy.

Orthopedic:

#152-2007: Urinary Levels of a Knee Osteoarthritis Biomarker During the Early Period After ACL ReconstructionPurpose: To determine if urinary levels of CTX-II are elevated in the early period following ACL reconstruction. To examine the association of

urinary levels of CTX-II with self report of function in the early period following ACL reconstruction. Study Phase: Active enrollment through March 2010Principal Investigator: Terese L Chmielewski, Ph.D., PT, (352) 273-6104 or [email protected] Enrollment Criteria: Participants must be between 15-30 years old and receiving rehabilitation at Brooks Center for Sports Therapy. They cannot have had prior knee surgery. Also looking for control subjects who are 15-30 years old that have no lower extremity injury.

#09-059: Assessment of Proposed Risk Factors for Knee Injuries in High School Males and Female AthletesPurpose: To determine the biomechanical differences in movement patterns between male and female high school athletes. The secondary objective is to prospectively determine the risk for two knee injuries: anterior cruciate ligament injury and patellofemoral pain syndrome.Study Phase: Active enrollment at Brooks Center for Sports Therapy onlyPrincipal Investigator: Michele Boling. Ph.D., LAT, ATC, (904) 620-1563 or [email protected] Criteria: Participants must be enrolled in freshman to senior year of high school at Nease or Ponte Vedra High school. They must have specific intent of participating in Junior Varsity or Varsity sports.

#582-2007: Immediate Effects on Sensation Perception Following Manual Therapy Interventions to the Thoracic SpinePurpose: The purpose of this study is to: 1) identify if there is an immediate local hypoanalgesic effect associated with a cervical region spinal manipulative therapy intervention in the upper-extremities; 2) to identify if there is a difference in immediate local hypoanalgesic effects based on treatment (spinal manipulative therapy vs. specific exercises) and; 3) to identify if any psychological factors influence outcomes via self-report questionnaires.Study Phase: Active Enrollment Principal Investigator: Mark Bishop, Ph.D., PT, (352) 273-6112Enrollment Criteria: Must be between 18-35 years of age and have no neck or upper-extremity complaints within the past 60 days.

Spinal Cord Injury:

#05-027: The Learning Trajectory for Patients with Spinal Cord Injury and the Teaching Trajectory for Spinal Cord Injury Nurses in a Rehabilitation SettingPurpose: To investigate the best ways for a rehabilitation nurse to teach a patient with a SCI and how to facilitate learning.Study phase: Active enrollment

#313-2006: Restoring Walking in Non-Ambulatory Children with Severe Chronic Spinal Cord InjuryPurpose: To determine if locomotor training can restore voluntary stepping in the absence of or with minimal voluntary movement in some individuals with severe chronic spinal cord injury. Study phase: Active enrollment

Brain Injury:

#254-2006: Developing a Computer Adaptive Cognitive Measure in Traumatic Brain InjuryPurpose: To develop a way to measure cognitive skills during various phases of recovery in TBI using a computer adaptive technology. Study phase: Data AnalysisPrincipal Investigator: Craig Velozo, Ph.D., (352) 273-6128 or [email protected]

Page 8: Innovations Fall 09

Enrollment Criteria: Participants in this study include patients with a traumatic brain injury, their clinicians, physicians and caregivers. Recruitment will be from the acute phase to 6 months post rehabilitation phase.

#139-07: Neuro-Cognitive Subtypes of Traumatic Brain Injury: Relevance to Cognitive RehabilitationPurpose: To identify clinically-meaningful neuro-cognitive subtypes of severe traumatic brain injury survivors using functional magnetic resonance imaging (fMRI) and to determine their differential responsiveness to cognitive rehabilitation using a brief trial of goal management. Study Phase: Active Principal Investigator: William M. Perlstein, Ph.D., (352) 273-6139 or (352) 222-8870 or [email protected] Criteria: Participants must have suffered a severe TBI and be within 1-2 years post injury. They are also looking for 10 neurologically healthy adults.

#2007-2002: Brain Injury Coping Skills (BICS)Purpose: The purpose of this study is to gather pilot data examining the efficacy of a structured treatment group, called Brain Injury Coping Skills (BICS), and designed for individuals with acquired brain injury (ABI) and their caregivers. Study Phase: Data AnalysisCo-Principal Investigator: Jeffrey Wertheimer, Ph.D., Enrollment Criteria: Participants must be between 18 and 60 years old and have experienced an Acquired Brain Injury (including TBI, intercerebral hemorrhage, encephalopathies and strokes). They must be a native English speaker or non-native speaker with conversational proficiency in the English language and the caregiver must be willing to participate in the study.

#UF03-2008-108: TBI-PBE: Traumatic Brain Injury - Practice Based EvidencePurpose: To identify patient characteristics, including co-morbidity and complications, which explain variation in outcomes for TBI patients in acute rehabilitation. To identify medical procedures and therapy interventions or combinations of procedures and interventions associated with better outcomes, while controlling for patient characteristic. Aims to determine whether specific impairment by specific therapy interactions is associated with better outcomes.Study Phase: Active Enrollment through May 2011Co-Principal Investigator: Dr. Cynthia Beaulieu, Ph.D., ABPP-Cn, (904) 345-7651 or [email protected]

Falls:

#435-2008: Psychosocial Factors Influence on Response to Falls Intervention Program in Older AdultsPurpose: The purpose of this study is to find out how individuals attitudes and thoughts, such as fear they might have about falling or pain, might affect the changes that they experience during intervention for a balance program. Study Phase: Active EnrollmentPrincipal Investigator: Mark Bishop, Ph.D., PT, (352) 273-6112 Enrollment Criteria: Must be between 60 and 90 years old and had a history of two falls in the past 12 months.

There is no charge for participation in any of the above clinical trials. Individuals may be compensated for their participation in some trials. For further information about research or to learn more about participation a trial, please contact us at (904) 306-8970. You may also visit our Web site at brookscenter.org.

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If you have questions about any of the research going on at the Brooks Center, check out our web site at brookscenter.org. Find out what studies are underway, how to enroll in a study, and how

to conduct research at the Brooks Center. Our ever-changing Web site hosts our recently published articles, clinical trial updates and educational opportunities.

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