19
SWALLOWING DISORDERS (RE MARTIN, SECTION EDITOR) A Systematic Review of Randomized Controlled Trials in the Field of Dysphagia Rehabilitation Giselle Carnaby Aarthi Madhavan Published online: 26 September 2013 Ó Springer Science + Business Media New York 2013 Abstract We carried out a systematic review of ran- domized controlled trials (RCT) of oropharyngeal swal- lowing interventions conducted between years 2010 and 2013. A systematic literature search of RCTs was con- ducted using databases MEDLINE (PubMed), PsychInfo, Google Scholar, EBSCO, PROQUEST, Web of Science, and grey literature. Data were abstracted from all eligible studies by the first author and independently assessed by two raters using the Van Tulder scale. A total of 15 RCTs of behavioral swallowing therapy were included for eval- uation. Significant heterogeneity between experimental studies was noted. Only 33 % (5) of studies included met the quality criterion identified by the van Tulder scale for high study rigor. Data supporting swallowing rehabilitation methods with adult dysphagic patients is advancing. Although studies intervention approaches remain diverse, the use of RCT designs is increasing with noted improve- ments in control methods. More research is needed to ascertain the most optimal intervention methodology for dysphagia rehabilitation. Keywords Deglutition Á Swallowing Á Dysphagia randomized controlled trial Á Rehabilitation Á Systematic review Introduction Health care decisions are frequently directed by the best available evidence from research studies. As both diag- nostic and treatment options multiply rapidly in health care, increases in available research bring with it chal- lenges in identifying which studies are of the highest quality. This challenge is made more difficult when dif- ferent studies provide results that support different con- clusions or lead a field erroneously through bias in reporting. To answer these challenges, researchers have developed methods to synthesize and evaluate research from multiple studies. Systematic reviews represent one method to rig- orously compile scientific evidence to answer questions regarding the state of science in an area. They can help clinicians make decisions when similar studies present apparently confusing or conflicting results [1]. Different research designs shed different amounts of light on how treatments work under controlled conditions. Some designs provide information on the association between treatments and their outcomes, but do not control for the myriad of intervening or confounding issues sur- rounding treatment applications, e.g., age, gender, disease severity, co-interventions, enthusiasm, etc. One design that provides definitive evidence of intervention efficacy is the randomized controlled trial (RCT) [2]. The RCT is one of the simplest, but most powerful research designs available to a researcher to evaluate the efficacy of an intervention. The key feature of this design is that, after an assessment of eligibility, subjects in the study are randomly and independently assigned to receive one or other treatments under investigation. Once randomized the groups are followed in exactly the same way and only differences in response to the treatment they receive are G. Carnaby (&) Department of Behavioral Science and Community Health, University of Florida, Gainesville, FL 32610, USA e-mail: [email protected]fl.edu A. Madhavan Department of Speech Language and Hearing Sciences, University of Florida, Gainesville, FL 32610, USA 123 Curr Phys Med Rehabil Rep (2013) 1:197–215 DOI 10.1007/s40141-013-0030-1

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SWALLOWING DISORDERS (RE MARTIN, SECTION EDITOR)

A Systematic Review of Randomized Controlled Trials in the Fieldof Dysphagia Rehabilitation

Giselle Carnaby • Aarthi Madhavan

Published online: 26 September 2013

� Springer Science + Business Media New York 2013

Abstract We carried out a systematic review of ran-

domized controlled trials (RCT) of oropharyngeal swal-

lowing interventions conducted between years 2010 and

2013. A systematic literature search of RCTs was con-

ducted using databases MEDLINE (PubMed), PsychInfo,

Google Scholar, EBSCO, PROQUEST, Web of Science,

and grey literature. Data were abstracted from all eligible

studies by the first author and independently assessed by

two raters using the Van Tulder scale. A total of 15 RCTs

of behavioral swallowing therapy were included for eval-

uation. Significant heterogeneity between experimental

studies was noted. Only 33 % (5) of studies included met

the quality criterion identified by the van Tulder scale for

high study rigor. Data supporting swallowing rehabilitation

methods with adult dysphagic patients is advancing.

Although studies intervention approaches remain diverse,

the use of RCT designs is increasing with noted improve-

ments in control methods. More research is needed to

ascertain the most optimal intervention methodology for

dysphagia rehabilitation.

Keywords Deglutition � Swallowing � Dysphagia

randomized controlled trial � Rehabilitation � Systematic

review

Introduction

Health care decisions are frequently directed by the best

available evidence from research studies. As both diag-

nostic and treatment options multiply rapidly in health

care, increases in available research bring with it chal-

lenges in identifying which studies are of the highest

quality. This challenge is made more difficult when dif-

ferent studies provide results that support different con-

clusions or lead a field erroneously through bias in

reporting.

To answer these challenges, researchers have developed

methods to synthesize and evaluate research from multiple

studies. Systematic reviews represent one method to rig-

orously compile scientific evidence to answer questions

regarding the state of science in an area. They can help

clinicians make decisions when similar studies present

apparently confusing or conflicting results [1].

Different research designs shed different amounts of

light on how treatments work under controlled conditions.

Some designs provide information on the association

between treatments and their outcomes, but do not control

for the myriad of intervening or confounding issues sur-

rounding treatment applications, e.g., age, gender, disease

severity, co-interventions, enthusiasm, etc. One design that

provides definitive evidence of intervention efficacy is the

randomized controlled trial (RCT) [2].

The RCT is one of the simplest, but most powerful

research designs available to a researcher to evaluate the

efficacy of an intervention. The key feature of this design is

that, after an assessment of eligibility, subjects in the study

are randomly and independently assigned to receive one or

other treatments under investigation. Once randomized the

groups are followed in exactly the same way and only

differences in response to the treatment they receive are

G. Carnaby (&)

Department of Behavioral Science and Community Health,

University of Florida, Gainesville, FL 32610, USA

e-mail: [email protected]

A. Madhavan

Department of Speech Language and Hearing Sciences,

University of Florida, Gainesville, FL 32610, USA

123

Curr Phys Med Rehabil Rep (2013) 1:197–215

DOI 10.1007/s40141-013-0030-1

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compared. The power of the design lies in its ability to

minimize bias in treatment allocation and balance prog-

nostic factors between the groups. Well-conducted RCTs

minimize bias by controlling known and unknown factors

(confounders) that may distort treatment effects. Unfortu-

nately, it is estimated that fewer than 10 % of all literature

published are well-conducted RCTs, with \5 % reported

from the area of rehabilitation [3, 4]. Despite the strength

and benefits of RCTs, poorly conducted or poorly reported

trials can yield misleading data and misdirect knowledge

and development of a field.

Like other areas of health care, dysphagia intervention

methods are diverse and rapidly advancing within the lit-

erature. Common categories of dysphagia rehabilitation

methods include; behavioral maneuvers, behavioral com-

pensations, exercise interventions, dietary interventions

(including modified diets and enteral feeding methods),

pharmaceutical applications, electro-physical applications,

and sensory-motor applications to mention but a few. To

date, evaluations of the strength of data supporting swal-

lowing interventions have been equivocal. Some reviews

identifying an increase in the quality of supportive data

whilst others have admonished the field for a lack of sup-

portive evidence and suggested the need for more rigorous

study designs [5, 6] (Fig. 1).

Recently, a published review of abstracts presented to

an international dysphagia meeting (Dysphagia Research

Society) over the last decade (2001–2011) suggested that

there has been a surge in the use of more rigorous

research designs to evaluate swallowing. In fact, they

reported that the use of RCT methodologies in that group

had tripled since 2001, and that at present RCTs consti-

tuted 3.3 % of all abstracts presented at this meeting [7].

However, data for this review were generated from study

abstracts only and the authors did not evaluate the indi-

vidual study rigor of each trial using a validated quali-

tative analysis system.

To further evaluate the use of rigor in recent RCT

studies in the field of dysphagia rehabilitation, we proposed

to undertake a systematic review of all RCTs of behavioral

intervention for oro-pharyngeal dysphagia during the per-

iod from January 2010 to June 2013.

Fig. 1 Flow chart of study

selection process

198 Curr Phys Med Rehabil Rep (2013) 1:197–215

123

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Methods

Study Identification

Studies were identified using searches on MEDLINE

(PubMed), PsychInfo, Google Scholar, EBSCO, PRO-

QUEST Web of Science, and grey literature. In addition,

meeting abstracts and Cochrane Reviews and reviews of

reference lists of related book chapters and journal articles

from January 2010 to June 2013 were screened. A com-

prehensive list of search terms included; ‘‘swallowing

intervention,’’ ‘‘swallowing treatment trial,’’ ‘‘randomized

clinical trial’’, ‘‘RCT’’, ‘‘randomized controlled clinical

trial’’, ‘‘and swallowing rehabilitation trial’’, ‘‘dysphagia

rehabilitation’’. MESH terms (PubMed) used included,

‘‘humans’’, ‘‘dysphagia’’, ‘‘swallowing trial’’, ‘‘treatment’’.

For databases allowing advanced search techniques, arti-

cles were restricted to RCTs. Potentially eligible articles

were first screened for relevance by the first author, using

article titles and then abstracts. Articles that appeared to

meet eligibility criteria after this initial review were then

reviewed independently by the first and second authors,

using the measures described below.

Inclusion Criteria

The current review included RCTs that assessed the impact

of behavioral interventions to reduce or ameliorate oro-

pharyngeal dysphagia. Due to the differences in interven-

tion format and treatment goals for programs involving

children and adolescents, the current review was restricted

to studies investigating adults (age C18) only. To be eli-

gible for inclusion, the following inclusion/exclusion cri-

teria were used: (1) must include a randomized control trial

design; (2) published in English or capable of being

translated; (3) accessible in full text; (4) evaluated an oro-

pharyngeal swallowing intervention; (5) assessed a mea-

surable swallowing outcome; (6) did not evaluate a surgical

interventions; (7) did not evaluate a pharmaceutical inter-

vention; and (8) was not a device trial.

RCT

For the purposes of this systematic review, an RCT was

defined a priori as a study in which subjects are randomly

allocated (by chance alone) to receive one of several

clinical swallowing interventions. One of these interven-

tions must be a standard of comparison or control. This

control group should be receiving either no treatment or

receive the current standard treatment. The use of a placebo

comparison only without a standard control comparison

will be considered a quasi-experimental trial, as the pla-

cebo effect alone cannot be adequately identified.

Furthermore, for the purposes of qualitative grading,

reviewers were advised that an acceptable randomization

procedure should include either use of computer generated

random numbers or random numbers tables. In addition,

concealed allocation should be described as either use of a

centralized or independently controlled randomization

procedure, serially-numbered identical containers, or ran-

domization sequences not readable until allocation.

Data Extraction

The first author (G.C.) systematically abstracted data from

all articles reviewed in full text including authors, year in

which the study was published, country in which the study

was conducted, characteristics of the sample (e.g., sample

size, gender, age range, diagnostic group, and treatment

type), the intervention and control group’s methodology,

length of intervention, length of follow-up, and all relevant

dysphagia outcome measures. For studies employing more

than one treatment arm (or those using factorial designs),

only data related to the current review were used. To cal-

culate intervention effect sizes, mean differences between

an intervention and a control group and associated standard

deviations (if available) or next through the use of either

pre- and post-test means and standard deviations, group n,

and F ratio were abstracted. If more than one intervention

arm met criteria for inclusion, data were combined to

create pooled estimates. Following this, effect data were

standardized using accepted methods to single comparable

effect metric, Cohen’s d.

Quality Assessment

Two independent reviewers, blinded to the study’s’

authors, author’s affiliations, and journal, independently

used the van Tulder scale to determine the quality of the

trials. Where a selected study included an author of this

paper, it was re-directed to a third independent reviewer.

The van Tulder scale is a qualitative assessment tool

designed to make assessments on 11 components of RCT

study design including randomization method, allocation

concealment, baseline characteristics, patient blinding,

therapist blinding, observer blinding, co-intervention con-

trol, compliance, drop-out rate, end-point assessment time

point, and intention-to-treat analysis (see Table 3 in

Appendix). The reviewer is required to select ‘yes’, ‘no’, or

‘don’t know’ for each item. A rating of ‘1’ is allocated for

any affirmative response, or ‘0’ for ‘no’, or ‘don’t know.

When C5 items are satisfied (C5 points), the quality of the

report is deemed high [8]. The van Tulder scale has pre-

viously been evaluated for interrater reliability, face, con-

tent, and concurrent validity [8]. In the present study, only

‘high quality’ rated studies were included in the analysis of

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primary effect within the systematic review (see Table 4 in

Appendix).

Reliability

Two independent raters utilized a standardized rating sheet

to record study details for the van Tulder qualitative

grading (Table 1). The inter-class correlation coefficient

for van Tulder scores between the reviewers was

a = 0.976 (95 % CI 0.938–0.991).To further explore areas

of concordance in ratings across studies a fixed marginal

kappa analysis [9] was conducted and revealed 94 %

agreement in coding across studies. Kappa values of 0.75

or higher reflect excellent agreement between raters [10].

Overall rater agreement was strong across categories of the

scale, ranging from 86 to 100 % agreement. The item

demonstrating the greatest discrepancy between raters was

item H; ‘‘were co-interventions avoided or controlled’’.

This item was often not explicitly stated by authors and

overall agreement for this item was 86 %. Inconsistencies

identified between raters were later discussed and resolved

by consensus.

Results

Initial queries using the search terms listed yielded a total

of 164 articles of which the titles were screened. Following

this, 128 studies did not meet the inclusion criteria and

were excluded (Table 1). Thirty-three studies were evalu-

ated by abstract review, of which ten were deemed ineli-

gible for the reasons; failure to use of RCT design (n = 2)

lack of control arm (n = 2), lack of randomization (n = 3),

review article only (n = 3).After reviewing the full text

studies a further three studies were eliminated due to fail-

ure to provide randomization details (n = 2) and providing

a protocol only (n = 1). In total, 20 studies met all eligi-

bility criteria and were included in the systematic review.

While all the studies included self-identified as RCTs, only

15 met the RCT criteria by including a true comparison

(control) arm [11–26]. A further 5 studies utilized sham/

placebo comparators only (without a standard control

comparison) or non-randomized controls and were deemed

quasi-randomized trials [26–30].

Quality Ratings

The 15 studies identified as RCTs averaged a quality rating

score of a 4.46 (SD 2.6), with scores ranging from 1 [21] to

a score of 9 [24]. The modal score for the group was 4

(range 1–9). Of the 15 included RCTs, five studies were

conducted in Asia with an average quality rating of 2.6 (SD

0.89), four trials were conducted in the USA and scored an

average quality rating of 7 (SD 2.1), two in Europe with an

average quality rating of 3 (SD 1.4), and two from Aus-

tralia rating 6 (SD 2.8) and a single trial from the UK

scoring 7.

Only 5 RCTs met the van Tulder criteria ([5) indicating

high quality trials [11, 14, 19, 22, 24]. Only 46 % (7) of

studies provided adequate detail regarding the randomiza-

tion and concealment procedures, while 86 % (13) studies

identified and confirmed similarity of baseline group

comparability (item C) and 93 % (14) defined similar

timing of evaluation points between the groups (item J).

26 % (4) of studies reported post-intervention data with

\20 % attrition [13, 14, 16, 23] and only 20 % reported

the compliance of subjects to the treatment provided [11,

22, 24]. Limited blinding was demonstrated across studies

with only 13 % (2) of studies blinding subjects and 6 % (1)

blinding therapists. Further, only 53 % (8) studies [11, 13,

14, 17, 19, 22, 24, 25] reported that assessors who mea-

sured the main outcome were blinded to treatment alloca-

tion. Lastly, 46 % (7) of studies were conducted with

intent-to-treat analysis [11, 14, 17, 19, 22, 24] (Table 1).

Study Characteristics

Ten studies were two-arm RCTs (intervention and control),

while 5 were three-arm trials were either intervention,

placebo, and control [19, 24] or intervention, intervention,

and control [12, 22, 23]. Only one study was a cluster trial

of 19 centers [14]. The average size of study recruitment

was 64.5 (SD 37.4), with the range from 16 [21] to 130 [22]

subjects. The mean ages of patients enrolled across the

RCTs ranged from 25.4 [18] to 80 [13]. The proportion of

subjects recruited were 1.5 times more likely to be male

(1,190) versus female (793).

The most frequent intervention group diagnosis was

head and neck cancer (40 %), followed by stroke (27 %).

Two studies were conducted using acute care patients [11,

14], four with sub-acute rehabilitation patients [12, 13, 21,

24] and eight with either chronic conditions [23] or patients

presenting for outpatient-based medical interventions [15–

17, 19, 20, 22, 25]. An additional study utilized healthy

normal volunteers only [18].

In four studies, confirmation of dysphagia status was

made on the basis of a non-validated clinical examination

[13, 14, 23] or patient history [20]. Seven studies utilized a

validated clinical exam only [11], videofluoroscopic

examination only [21], or both methods [12, 18, 19, 25].

Additionally, two studies utilized patient report or a quality

of life survey [15, 17] and only one study did not specifi-

cally report the process for dysphagia status confirmation at

study onset [16].

200 Curr Phys Med Rehabil Rep (2013) 1:197–215

123

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Curr Phys Med Rehabil Rep (2013) 1:197–215 201

123

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Nature of the Interventions

The 15 RCTs included a diverse range of swallowing

intervention methodologies (Table 2; Table 5 in Appendix)

including: dietary [11, 13, 21], electrotherapeutic [12, 23–

25], preventative behavioral exercise [16, 17, 19, 22],

behavioral maneuvers and compensations [15, 18], pro-

gram effectiveness [14], and behavioral exercise alone

[20]. Within the quasi-experimental trials, three studies

evaluated alternative medicine approaches [28–30], one

evaluated a postural adjustment [27], and another evaluated

respiratory strength training [26].

Recruitment into the studies was variable across the

groups. Three studies reported consecutive recruitment

from admission to medical care [11, 14, 24], while a further

six studies reported consecutive recruitment from outpa-

tient admission [16, 17, 19, 22, 25], five studies did not

report time to recruitment [12, 13, 20, 21, 23], one study

reported recruitment on average 4.7 years post-medical

treatment [15], and one utilized volunteers [18] (Table 2).

Intervention Timing

The duration of intervention was highly variable, ranging

from 3 days to 4 months. The average number of days

treatment was provided across all studies was [5 weeks

(mean days: 40.47, SD 36.0).The total amount of inter-

vention prescribed within a treatment period was also

variable ranging from 1.5 to 189 h, with the average for all

studies equal to 55.7 (SD 61) h. The frequency of treatment

provided (sessions/day) was on average 1.7 (SD 0.9) with

seven studies providing daily treatment [11–14, 21, 23, 24],

three studies providing treatment twice daily [19, 20, 22],

and four studies providing intervention three times a day

[15–17, 25]. One study also provided intervention on

alternating days [18]. In general, studies evaluating dietary

interventions provided care on a daily basis. Studies eval-

uating electrotherapeutic interventions provided care for

30–60 min daily, while prophylactic exercise interventions

were more often provided 2–3 times daily for 15–45 min.

Behavioral interventions only [15, 18, 20] were highly

variable, ranging from 1 to 3 times a day.

Outcome Assessment

The assessments of outcomes in 15 RCTs were evaluated at

mixed time points. Nine studies evaluated pre- and post-

intervention only [11–16, 18, 21, 25], three studies com-

pleted pre- and post-intervention measures and followed

patients out to 3 months [22–24], and three followed

patients for C6 months [17, 19, 20]. The outcome evalu-

ated by the majority of studies (7) was swallowing function

measured by a clinical swallowing evaluation [12, 15, 17,

20, 23, 25]. Two studies evaluated swallowing physiology

as the primary target using videofluoroscopic analysis [16,

18]. Two studies evaluated swallowing muscle composi-

tion using T2-weighted MRI [19, 22]. Two studies evalu-

ated the larger functional outcomes of lung infection from

clinical report, and death/dependency using the modified

Rankin Scale [13, 14]. Lastly, two studies evaluated fluid

and enteral intake [11, 13]. In total, six trials utilized non-

validated primary outcome tools [12, 13, 16, 18, 20, 23],

and of these four were non-validated clinical assessment

measures and two were non-validated instrumental

approaches. Nine studies utilized validated clinical and

instrumental outcome assessment tools [11, 14, 15, 17, 19,

22, 24, 25].

Secondary outcomes were evaluated in 93 % of trials.

Only one study utilized a single primary outcome [18]. The

range of secondary outcomes reviewed included: need for

additional medical intervention [11, 17, 21], weight change

[11, 16, 19], occurrence of dysphagia-related adverse

events [11, 14, 19–21, 24], change in core temperature [13,

14], dietary/fluid intake [13, 16, 19, 22–24], quality of life

[12, 13, 21–23], swallow physiology/biomechanics [12, 24,

25], chemosensory function [19], clinical swallowing

ability [14, 19, 22], mouth opening [15, 16, 19], mouth/

neck pain [16, 19, 20, 22], psycho-social measures (fatigue,

depression, mood, anxiety, fear) [19, 22], and length of stay

[14] .

Statistical Approach

Of the total 15 RCTs, four studies provided descriptive and

uni-variate analyses only [12, 13, 15, 25], four provided

descriptive and non-parametric analyses [16–18, 23] and

four trials [11, 14, 19, 22] provided descriptive, uni-variate,

and multivariate results. Eight studies conducted appro-

priate statistical analyses for their reported sample size and

statistical plan [11, 12, 14–16, 19, 22, 24]. Of this group,

five studies, however, did not meet statistical reporting

standards by failing to provide specific parametric and non-

parametric details beyond providing a p value for results

[31]. A further seven studies did not conduct appropriate

statistical analyses including: inappropriate analysis for

stratification reported [13], inadequate sample size for RCT

to ensure randomization [17, 18], incorrect application of

parametric analyses [21], and failure to adjust for multiple

testwise error [17, 20, 25]. Lastly, a single study’s results

could not be confidently evaluated as the numbers reported

in the text and tables conflicted [23].

Reported Outcomes

Eleven (73 %) of the RCTs reported a positive outcome

from the intervention used to remediate dysphagia [11–15,

202 Curr Phys Med Rehabil Rep (2013) 1:197–215

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nvolu

me

of

feed

and

fluid

s

Pro

port

ion

of

par

tici

pan

tsnot

rece

ivin

gan

yfe

eds

Supple

men

tal

par

ente

ral

feed

s

#of

NG

inse

rtio

ns

#ch

est

X-r

ays

toch

eck

NG

inse

rtio

n

Chan

ge

inw

eight

Tre

atm

ent

fail

ure

(defi

ned

asP

EG

inse

rtio

nw

ithin

two

wee

ks

or

aban

doned

NG

feed

s)

Adver

seev

ents

(incl

uded

—nas

al

trau

ma,

ches

t

infe

ctio

n,

dia

rrhea

,

vom

itin

g,

GI

ble

ed,

elec

troly

te

abnorm

alit

ies,

and

tole

rabil

ity)

Kar

agia

nnis

etal

.[1

3]

Eff

ects

of

ora

lin

take

of

wat

erin

pat

ients

wit

h

oro

phar

yngea

l

dysp

hag

ia

Aust

rali

an

=76

Exp

=42

Contr

ol

=34

39:3

7E

xp

=80

(7)

Contr

ol

=79

(11)

Str

oke,

Dem

enti

a,

Alz

hei

mer

’sdis

ease

,

Par

kin

son’s

dis

ease

,

cance

r,m

oto

rneu

ron

dis

ease

,H

unti

ngto

n’s

dis

ease

,m

oto

r

veh

icle

acci

den

t

Per

sons

wit

h

Dysp

hag

iaw

ho

had

bee

npre

scri

bed

a

modifi

eddie

t

Thic

ken

eddie

t

modifi

cati

on

?F

ree

wat

er

Pre

sence

of

lung

com

pli

cati

ons

mea

sure

dby

physi

cian

revie

w

Core

body

tem

per

ature

Dai

lyfl

uid

inta

ke

Qual

ity

of

life

Car

law

etal

.[2

1]

Outc

om

esof

apil

ot

wat

er

pro

toco

lpro

ject

ina

rehab

ilit

atio

nse

ttin

g

Can

ada

n=

16

Exp

=9

Contr

ol

=7

a

Contr

ol

cross

ed

over

to

exper

imen

tal

foll

ow

ing

a

14-d

ayco

ntr

ol

phas

ea

10:0

6M

ales

=53.7

,

fem

ales

=44.1

Str

oke,

spin

alco

rd

inju

ry,

trau

mat

ic

bra

inin

jury

‘‘T

hin

liquid

dysp

hag

ia’’

Beh

avio

ral

?fr

ee

wat

er

Flu

idin

take

Qual

ity

of

life

Adver

seev

ents

aspir

atio

npneu

monia

Init

iati

on

of

intr

aven

ous

fluid

s

Re-

init

iate

tube—

feed

ing

Acu

teca

re

hosp

ital

izat

ion

Curr Phys Med Rehabil Rep (2013) 1:197–215 203

123

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Ta

ble

2co

nti

nu

ed

Stu

dy

Countr

yof

ori

gin

Sam

ple

size

Gen

der

(M:F

)

Sam

ple

age(

Mea

n,

SD

)

Dia

gnost

icgro

up

Sev

erit

yof

dysp

hag

ia

(bas

elin

e)

Tre

atm

ent

type

Pri

mar

youtc

om

e

mea

sure

s

Sec

ondar

youtc

om

e

mea

sure

s

Inte

rven

tion

type

=el

ectr

oth

erapy

Xia

etal

.[1

2]

Tre

atm

ent

of

post

-str

oke

dysp

hag

iaby

vit

alst

im

ther

apy

couple

dw

ith

conven

tional

swal

low

ing

trai

nin

g

Chin

an

=120

Exp

(1)

=40

Exp

(2)

=40

Contr

ol

=40

76:4

4E

xp

(1)

=66.4

(15.6

)

Exp

(2)

=65.8

5

(14.6

)

Contr

ol

=65.3

(14.3

)

Str

oke

Sta

ndar

diz

ed

swal

low

ing

asse

ssm

ent

score

(Mea

n,

SD

)

Conven

tional

swal

low

ing

ther

apy

=37.9

(6.4

)

Vit

alS

tim

ther

apy

=38

(6.9

)

Vit

alS

tim

plu

s

conven

tional

swal

low

ing

ther

apy

=39.5

(7.1

)

Beh

avio

ral

?N

ME

SS

wal

low

ing

abil

ity

mea

sure

dby

bed

side

swal

low

ing

asse

ssm

ent

on

stan

dar

diz

ed

swal

low

ing

asse

ssm

ent

Surf

ace

elec

trom

yogra

phy

Vid

eofl

uoro

scopic

swal

low

ing

study

Sw

allo

win

gre

late

d

qual

ity

of

life

mea

sure

don

SW

AL

-

QO

L

Hei

jnen

etal

.[2

3]

Neu

rom

usc

ula

rel

ectr

ical

stim

ula

tion

ver

sus

trad

itio

nal

ther

apy

in

pat

ients

wit

h

Par

kin

son’s

dis

ease

and

oro

phar

yngea

l

dysp

hag

ia:

effe

cts

on

qual

ity

of

life

The Net

her

lands

n=

85

Exp

(1)

senso

ry=

30

Exp

(2)

moto

r=

27

Contr

ol

=28

Num

ber

sin

table

and

text

do

not

mat

ch.

Not

calc

ula

ble

Med

ian

age

Exp

(1)

=66

Exp

(2)

=65

Contr

ol

=69

Par

kin

son’s

dis

ease

Dysp

hag

iase

ver

ity

scal

e(D

SS

)

(med

ian

score

s)

NM

ES

-S=

74

NM

ES

-M=

72

Contr

ol

=59

Beh

avio

ral

and

NM

ES

Chan

ge

inD

SS

score

SW

AL

-QO

Lsc

ore

FO

ISsc

ore

MD

AD

Isc

ore

Long

etal

.[2

5]

Ara

ndom

ized

contr

oll

ed

tria

lof

com

bin

atio

n

ther

apy

of

neu

rom

usc

ula

rel

ectr

ical

stim

ula

tion

and

bal

loon

dil

atat

ion

inth

e

trea

tmen

tof

radia

tion-

induce

ddysp

hag

iain

nas

ophar

yngea

l

carc

inom

apat

ients

Chin

an

=60

Exper

imen

tal

=31

Contr

ol

=29

29:3

1E

xp

=56.5

(8.7

)

Contr

ol

=55.8

(7.9

7)

Nas

ophar

yngea

l

carc

inom

aw

ith

radia

tion

induce

d

stri

cture

s

Not

report

edB

ehav

iora

l

exer

cise

?N

ME

S

Wat

ersw

allo

wte

st

(WS

T)

Ora

ltr

ansi

tti

me,

swal

low

reac

tion

tim

e,

phar

yngea

ltr

ansi

t

tim

e,la

ryngea

lcl

osu

re

dura

tion

asm

easu

red

on

vid

eofl

uoro

scopic

swal

low

study

Car

nab

yet

al.

[22]

Ara

ndom

ized

tria

lof

NM

ES

vs.

trad

itio

nal

dysp

hag

iath

erap

yaf

ter

stro

ke:

AN

SR

S

US

An

=53

Exp

(1)

=18

Sham

(2)

=18

Contr

ol

=17

25:2

8E

xp

(1)

=62.7

(12.2

)

Exp

(2)

=70.6

(11.8

)

Contr

ol

=64.3

(14.7

)

Sub-a

cute

dysp

hag

ic

stro

ke

Man

nA

sses

smen

tof

Sw

allo

win

g

(MA

SA

)sc

ore

s

(Mea

n)

Exp

NM

ES

=157.2

Sham N

ME

S=

154.6

Usu

alca

re=

158.4

Beh

avio

ral

exer

cise

s?

NM

ES

Impro

vem

ent

in

clin

ical

swal

low

ing

abil

ity

(MA

SA

)

Impro

vem

ent

in

ora

lin

take

level

(funct

ional

ora

l

inta

ke

scal

e—

FO

IS)

Impro

vem

ent

in

body

wei

ght

Impro

vem

ent

inV

FS

S

bio

mec

han

ical

ly

mea

sure

dphysi

olo

gy

of

swal

low

ing

Ret

urn

topre

-str

oke

die

t

Occ

urr

ence

of

dysp

hag

ia

rela

ted

med

ical

com

pli

cati

ons

204 Curr Phys Med Rehabil Rep (2013) 1:197–215

123

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Ta

ble

2co

nti

nu

ed

Stu

dy

Countr

yof

ori

gin

Sam

ple

size

Gen

der

(M:F

)

Sam

ple

age(

Mea

n,

SD

)

Dia

gnost

icgro

up

Sev

erit

yof

dysp

hag

ia

(bas

elin

e)

Tre

atm

ent

type

Pri

mar

youtc

om

e

mea

sure

s

Sec

ondar

youtc

om

e

mea

sure

s

Inte

rven

tion

type

=pre

venta

tive

beh

avi

ora

lex

erci

se

Car

nab

y-M

ann

etal

.[1

9]

‘‘P

har

yngoci

se’’

:A

random

ized

contr

oll

ed

tria

lof

pre

ven

tati

ve

exer

cise

sto

mai

nta

in

musc

lest

ruct

ure

and

swal

low

ing

funct

ion

duri

ng

hea

dan

dnec

k

chem

ora

dio

ther

apy

US

An

=58

Exp

=20

Sham

=18

Contr

ol

=20

44:1

4E

xp

=59

(10.4

)

Sham

=60

(12.2

)

Contr

ol

=54

(11.3

)

Hea

dan

dnec

kca

nce

rM

AS

Asc

ore

C178

indic

atin

gno

dysp

hag

ia

Beh

avio

ral

exer

cise

Musc

lesi

zean

d

com

posi

tion

mea

sure

dby

MR

I

Funct

ional

swal

low

ing

abil

ity

Mouth

open

ing

Chem

ose

nso

ryfu

nct

ion

Sal

ivat

ion

Nutr

itio

nal

stat

us

Occ

urr

ence

of

dysp

hag

ia-r

elat

ed

com

pli

cati

ons

Van

der

Mole

net

al.

[16]

Ara

ndom

ized

pre

ven

tive

rehab

ilit

atio

ntr

ial

in

advan

ced

hea

dan

dnec

k

cance

rpat

ients

trea

ted

wit

hch

emora

dit

her

apy:

feas

ibil

ity,

com

pli

ance

,

and

short

-ter

mef

fect

s

The Net

her

lands

n=

55

Exp

=27

Contr

ol

=28

39:1

0E

xp

=57

Contr

ol

=56

Hea

dan

dnec

kca

nce

rN

ot

report

edB

ehav

iora

lex

erci

se

and

man

euver

s

Sw

allo

win

g

funct

ion

mea

sure

dw

ith

vid

eofl

uoro

scopy

Usi

ng

pen

etra

tion–

aspir

atio

nsc

ale

Mouth

open

ing—

max

imum

inte

rinci

sor

Wei

ght

chan

ges

Body

mas

sin

dex

Ora

lIn

take—

mea

sure

d

usi

ng

the

funct

ional

ora

lin

take

scal

e

(FO

IS)

Pai

n—

usi

ng

avis

ual

anal

og

scal

efo

rpai

n

asse

ssm

ent

Kotz

etal

.[1

7]

Pro

phyla

ctic

Sw

allo

win

g

exer

cise

sin

pat

ients

wit

hhea

dan

dnec

k

cance

runder

goin

g

chem

ora

dia

tion

US

An

=26

Exp

=13

Contr

ol

=13

20:0

6E

xp

=57

(10)

Contr

ol

=62

(11)

Hea

dan

dnec

kca

nce

rN

odysp

hag

iaat

bas

elin

e

(Funct

ional

ora

l

inta

ke

scal

e(F

OIS

)

score

—7,

Per

form

ance

stat

us

scal

efo

rhea

dan

d

nec

kca

nce

r

pat

ients

(PS

S)

score

—100)

Beh

avio

ral

exer

cise

sF

OIS

,P

SS

scal

eP

EG

tube

inse

rtio

n

Car

nab

yet

al.

[22]

Dysp

hag

iapre

ven

tion

exer

cise

sin

hea

dnec

k

cance

r:phar

yngoci

se:

dose

resp

onse

study

US

An

=130

Exp

(1)

=50

Exp

(2)

=52

Contr

ol

=28

101:2

9E

xp

(1)

=58.3

(9.2

)

Exp

(2)

=57.8

(9.8

)

Contr

ol

=57.2

(9.8

)

Hea

dan

dnec

kca

nce

rM

AS

Asc

ore

(C178)

indic

atin

gno

dysp

hag

ia

Beh

avio

ral

exer

cise

sM

ainte

nan

ceof

musc

le

com

posi

tion

mea

sure

don

T2M

RI

Funct

ional

swal

low

ing

abil

ity

(mea

sure

don

MA

SA

and

FO

IS)

Pat

ient

per

cepti

on

of

swal

low

ing

funct

ion

and

qual

ity

of

life

(mea

sure

don

psy

cholo

gic

alsc

ales

for

hea

lth

rela

ted

QO

L)

Curr Phys Med Rehabil Rep (2013) 1:197–215 205

123

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Ta

ble

2co

nti

nu

ed

Stu

dy

Countr

y

of

ori

gin

Sam

ple

size

Gen

der

(M:F

)

Sam

ple

age

(Mea

n,

SD

)

Dia

gnost

ic

gro

up

Sev

erit

yof

dysp

hag

ia

(bas

elin

e)

Tre

atm

ent

type

Pri

mar

youtc

om

e

mea

sure

s

Sec

ondar

youtc

om

e

mea

sure

s

Inte

rven

tion

type

=beh

avi

ora

lm

aneu

vers

/com

pen

sati

on

splu

salt

ernati

vem

edic

ine

Fen

get

al.

[29]

Cli

nic

alst

udy

on

Tongyan

spra

y

for

post

-str

oke

dysp

hag

ia

pat

ients

:a

random

ized

contr

oll

edtr

ial

Chin

an

=120

Exp

=60

Sham

=60

79:4

1E

xp

=70.6

,

(10.5

)

Sham

=71.2

(10.3

)

Str

oke

(pat

ients

refe

rred

wit

h

dysp

hag

ia)

The

stan

dar

d

swal

low

ing

asse

ssm

ent

scal

e

(SS

A)—

score

[30

Beh

avio

ral

man

euver

s?

alte

rnat

ive

med

icin

e

Chan

ge

inS

SA

score

N/A

Chan

etal

.[3

0]

Ther

apeu

tic

effe

cts

of

acupunct

ure

for

neu

rogen

icdysp

hag

ia—

a

random

ized

contr

oll

edtr

ial

Chin

an

=87

Exp

=20

Contr

ol

1=

19

Contr

ol

2=

48

[non-

random

ized

]

43:4

4E

xp

=74.0

5(1

1)

Contr

ol

1=

80

(9.4

)

Contr

ol

2=

75.4

(12.8

)

Str

oke,

Par

kin

son’s

dis

ease

or

vas

cula

r

dem

enti

a

Royal

Bri

sban

ehosp

ital

outc

om

em

easu

refo

r

swal

low

ing

score

(RB

HO

MS

)bet

wee

n

5an

d5.5

for

all

thre

e

gro

ups

Beh

avio

ral

man

euver

san

d

alte

rnat

ive

med

icin

e

Chan

ge

inR

BH

OM

S

score

Food

and

fluid

consi

sten

cies

Yan

get

al.

[28]

Eff

ects

of

tran

scra

nia

ldir

ect

curr

ent

stim

ula

tion

(tD

CS

)on

post

stro

ke

dysp

hag

ia

South

Kore

a

n=

16

Exp

=9

Sham

=7

10:0

6W

hole

gro

up

report

edonly

71

(10.8

)

Str

oke

(acu

te

post

stro

ke

dysp

hag

ia)

‘‘H

isto

ryof

indir

ect

aspir

atio

n

sym

pto

ms’

Beh

avio

ral

modifi

cati

ons

and

man

euver

s?

elec

tro

stim

ula

tion

Inst

rum

ent

Sw

allo

win

gfu

nct

ion

mea

sure

don

vid

eofl

uoro

scopic

study

usi

ng

funct

ional

dysp

hag

ia

scal

e(F

DS

)

Mea

sure

don

vid

eofl

uoro

scopic

study

Ora

ltr

ansi

tti

me

[0T

T]

Phar

yngea

ltr

ansi

t

tim

e[P

TT

]

Tota

ltr

ansi

tti

me

[TT

T]

Inte

rven

tion

type

=pro

gra

mef

fect

iven

ess

Mid

dle

ton

etal

.[1

4]

Imple

men

tati

on

of

evid

ence

-bas

ed

trea

tmen

tpro

toco

lsto

man

age

fever

,hyper

gly

caem

ia,

and

swal

low

ing

dysf

unct

ion

inac

ute

stro

ke

(QA

SC

):a

clust

er

random

ized

tria

l

Aust

rali

an

=19

cente

rs

(n=

1,1

26

pat

ients

)

Exp

=10

(626

pat

ients

)

Contr

ol

=9

(500

pat

ients

)

[clu

ster

tria

lac

ross

19

cente

rs]

674:4

52

None

report

edA

cute

stro

ke

Not

report

edM

edic

alan

dbeh

avio

ral

man

agem

ent

pro

toco

ls

Dea

thor

dep

enden

cy

(Modifi

edR

ankin

scal

eC

2)

Funct

ional

dep

enden

cy(B

arth

el

index

)

Mea

nS

F—

36

men

tal

com

ponen

t

Mea

nS

F—

36

physi

cal

com

ponen

t

Mea

nte

mper

ature

for

firs

t72

h

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od

glu

cose

for

firs

t72

h

Pro

port

ion

of

swal

low

ing

scre

enin

g

under

taken

wit

hin

the

firs

t24

hof

adm

issi

on

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char

ge

dia

gnosi

s

of

aspir

atio

n

pneu

monia

Len

gth

of

hosp

ital

stay

Inte

rven

tion

type

=beh

avi

ora

lm

aneu

vers

/com

pen

sati

on

s

Tan

get

al.

[15]

Ara

ndom

ized

pro

spec

tive

study

of

rehab

ilit

atio

nth

erap

yin

the

trea

tmen

tof

radia

tion-i

nduce

d

dysp

hag

iaan

dtr

ism

us

Chin

an

=43

Exp

=22

Contr

ol

=21

32:1

1W

hole

gro

up

report

edonly

49.3

(11)

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ophar

yngea

l

carc

inom

a

Sco

reon

wat

ersw

allo

w

test

atbas

elin

e

(Mea

n,

SD

)

Exp

gro

up

=3.6

(1)

Contr

ol

gro

up

=3.8

(1)

Beh

avio

ral

Sev

erit

yof

dysp

hag

ia

(wat

ersw

allo

wte

st)

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smus

(LE

NT

/

SO

MA

score

Mea

nin

teri

nci

sor

dis

tance

)

206 Curr Phys Med Rehabil Rep (2013) 1:197–215

123

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Ta

ble

2co

nti

nu

ed

Stu

dy

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y

of

ori

gin

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ple

size

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der

(M:F

)

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ple

age(

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n,

SD

)

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gnost

ic

gro

up

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erit

yof

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hag

ia

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elin

e)

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atm

ent

type

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mar

youtc

om

e

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sure

s

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ondar

youtc

om

e

mea

sure

s

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etal

.[1

8]

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cise

usi

ng

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hold

ing

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low

does

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ve

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low

ing

funct

ion

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al

subje

cts

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a

n=

20

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=10

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ol

=10

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xp

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(3.9

8)

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ol

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(2.5

)

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lthy

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ysp

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icB

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iora

lm

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ver

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yola

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l

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ent,

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yngea

l

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rict

ion,

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erio

rphar

yngea

l

wal

lm

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ent

usi

ng

vid

eofl

uoro

scopy

N/A

Ter

reet

al.

[27]

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ecti

ven

ess

of

chin

-dow

n

post

ure

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ven

ttr

achea

l

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atio

nin

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ia

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ndar

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edbra

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ry.

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eofl

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scopy

study

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nn

=72

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atin

g)

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ol

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atin

g)

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(NB

:gro

ups

not

random

ized

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senta

tion

of

chin

dow

nm

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ver

alte

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ross

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/ran

dom

ized

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xp

=43

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ol

=51

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rogen

ic

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hag

ia

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oke

=45

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I=

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irat

ion

on

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eofl

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scopy

pri

or

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ura

lad

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atio

n(?

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tti

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yngea

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t

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e

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yngea

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e

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rven

tion

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ses

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che

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6]

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ion

and

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ease

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atio

nw

ith

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ST

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)

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(10.3

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kin

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ease

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om

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ree

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ance

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port

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ise

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cise

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etra

tion–

aspir

atio

nsc

ore

]on

vid

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eofl

uoro

scopic

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low

mea

sure

s

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allo

win

gqual

ity

of

life

[SW

AL

-

QO

L]

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etal

.[2

0]

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chea

ltr

acti

on

exer

cise

reduce

s

the

occ

urr

ence

of

post

oper

ativ

e

dysp

hag

iaaf

ter

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rior

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ical

spin

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rger

y

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an

=102

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ol

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1E

xp

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)

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ol

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vic

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ine

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ulo

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hy

or

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opat

hy

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report

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hag

ia

pri

or

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rger

y

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avio

ral

exer

cise

sB

azaz

dysp

hag

ia

score

s

Nec

kdis

abil

ity

index

Pai

nV

AS

-arm

Pai

nV

AS

-nec

k

Curr Phys Med Rehabil Rep (2013) 1:197–215 207

123

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17, 19–22, 25]. Positive outcomes included improved

nutritional intake [11, 24], increased fluid intake [13, 21]

improved swallowing ability [12, 15, 19, 20, 22, 24],

improved quality of life [22], improved swallow physiol-

ogy [25], reduced death or disability [14], increased mouth

opening [19, 22], maintenance of chemo-sensory function

[19], and maintenance of swallowing muscle composition

[19, 22].

Two studies reported negative outcomes for their pri-

mary variable [13, 24]. Three studies reported no change in

outcome from intervention [16, 18, 23]. In reviewing the

design quality rating and statistical conduct of each study,

five studies reporting positive outcomes could not be jus-

tified due to methodological and statistical issues [13, 17,

20, 21, 25]. An additional two studies with low methodo-

logical rigor and identified statistical issues did not report

improved outcomes for their sample and remained incon-

clusive [18, 23].

Discussion

Systematic reviews are conducted to appraise the volume

and strength of a body of research surrounding a topic. As

the name implies, they are systematic, organized, com-

prehensive, and structured investigations. A thorough sys-

tematic review can assist researchers and clinicians in

outlining the benefits of available treatments, and provide

direction for future work.

We conducted a systematic review of dysphagia reha-

bilitation and evaluated the quality of RCTs meeting rec-

ommended methodological rigor. Our review identified 15

studies meeting the a priori inclusion criteria for a ran-

domized trial of oro-pharyngeal dysphagia in adults over

the years 2010–2013. Of those studies, only five met the

criteria for high quality using a validated evaluation scale

[8]. Specific weaknesses of the lower rated studies inclu-

ded: incomplete details regarding randomization proce-

dures, lack of information on allocation concealment,

limited blinding of subjects and therapists to the provision

of the intervention, control of co-intervention contamina-

tion, and management/reporting of sample attrition.

Importantly, an additional five studies were designated as

quasi-experimental trials as they did not include a standard

control comparator in the trial design. If a study provides

only comparison between an active arm and a placebo,

critical information about the true and placebo effect of an

intervention cannot be fully obtained. For example, where

the natural progression of a disease is variable or unknown,

we would not be able to identify the true responders, as

some patients will garner benefit by any intervention alone

(enthusiasm bias). Without a true ‘‘control’’, the impact of

the placebo strategy cannot be determined and may lead to

exaggerated treatment effect estimation.

Another potential problem identified from the current

review is the continuing publication of trials with limited

sample sizes. Small clinical trials (n \ 80) using conven-

tional simple randomization methods may result in

imbalanced covariate distributions between treatment and

control groups. Similarly, smaller trials are often hampered

by power limitations in analysis resulting from their size.

The use of alternate methods of randomization that support

balance in smaller trials, including blocked, stratified, and

covariate adaptive designs, however, remain limited within

the dysphagia rehabilitation literature.

No matter how well designed an RCT, it is only as good

as its outcome assessment. In this review, we identified

only 60 % of studies utilizing validated outcome assess-

ment tools. The majority of studies used clinical dysphagia

assessment methods, with only 26 % utilizing both vali-

dated clinical and instrumental methods. Accuracy of

assessment using proven methods reduces investigator bias

and improves the ability for findings to be translated across

studies. Clearly, dysphagia researchers must continue to

strive to use outcome metrics that improve the accuracy

and clarity of measurement within trials to advance science

in this area.

This review has identified a diverse range of dysphagia

interventions and applications. Without accepted and uti-

lized standards, comparisons of outcomes or treatment

effects is not possible. The current RCTs reviewed dem-

onstrate little concordance in either timing of interventions,

duration of interventions, or frequency of application. The

only intervention area demonstrating any concordance was

the application of neuromuscular electrical stimulation

(NMES). This treatment method, although controversial in

outcome, was applied daily in all four studies reviewed.

Unfortunately, the exact timing, duration, and configura-

tion of this application were haphazard, underscoring the

lack of accepted standards in treatment approaches. Con-

sequently, RCTs in dysphagia rehabilitation would benefit

greatly from procedures to reduce variability of investiga-

tion and promote comparisons across studies.

The majority of RCTs in this review presented data from

pre- to post-evaluation comparisons. Only 20 % of trials

provided any outcome data beyond the post-intervention

time point. Moreover, only one study evaluated outcome

208 Curr Phys Med Rehabil Rep (2013) 1:197–215

123

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out to 12 months. Lack of follow-up and the inclusion of

methods to manage attrition of study samples is another

area that needs to be addressed in future research. Like-

wise, the use and application of statistical methods that

match the trial design and recruited sample sizes needs

further consideration. Many researchers did not conform to

statistical reporting standards for publication, providing

only p values without specific details of direction or vari-

ability of effect. The continued use of inadequate statistical

reporting within trials limits the ability to synthesize data

across swallowing studies (meta-analysis) or to inform

effect size calculation for future research protocols.

In this review, we sought to identify both published and

unpublished trials of dysphagia rehabilitation to evaluate

the scope and quality of recently completed research. Our

final study sample included 13 published RCTs and two

grey (unpublished) papers. The literature search included

here was comprehensive, including academic search pre-

mier, and conference proceedings and abstracts; as such,

we believe it reflects the current knowledge base in this

area. Despite this, it is possible that not all studies were

captured. Our review differs from previously published

systematic reviews [5–7] in that we included grey literature

within our sample. The addition of grey data is important

as they may be the only source of important up-to-date

information. Further, it may offer insight into unique

directions for a burgeoning field.

Although our study is distinct from previous systematic

reviews that have sought to evaluate dysphagia interven-

tions, our results are consistent with their findings that the

rigor of swallowing intervention trials remains lacking. It is

important to note, however, that the number of RCTs on

swallowing rehabilitation published over the last 2.5 years

has increased steadily. Previous reviews have identified a

publication rate of 0.36 trials/year, which has now risen to

an average of 6 per year [5, 6]. Moreover, the use meth-

odological control strategies within current trials is

continuing to advance.

Conclusion

Emerging evidence demonstrates that the breadth of dys-

phagia rehabilitation intervention methods is rapidly

advancing. The use of more advanced study designs has

also increased and the publication rate for RCTs appears to

be growing. Despite this, newly published RCTs continue

to demonstrate significant weaknesses in design and het-

erogeneity in treatment methods, limiting current compar-

isons and data to support the efficacy of dysphagia

rehabilitation approaches.

Compliance with Ethics Guidelines

Conflict of Interest Both authors are free of professional areas of

conflict of interest such as financial remuneration as employee, con-

sultant, or subcontractor with companies. G. Carnaby and A. Madh-

avan declare no conflicts of interest

Human and Animal Rights and Informed Consent This article is

not a specific study with human or animal subjects research per-

formed by any of the authors. Note however, that all studies refer-

enced in which the author GC participated, received local Institutional

Review Board approval for human subjects research.

Appendix

See Tables 3, 4, and 5.

Table 3 van Tulder scale [8]

Item Yes No/Dk

A. Was there a method of randomization using an

adequate procedure?

B. Was the treatment allocation concealed?

C. Were the groups similar at baseline regarding the

most

important prognostic indicators?

D. Was the patient blinded to the intervention?

E. Was the care provider blinded to the intervention?

F. Was the outcome assessor blinded to the

intervention?

G. Were co-interventions avoided or similar? Was

there

control for co-interventions?

H. Was the compliance acceptable in all groups?

I. Was the withdrawal/drop-out rate described &

acceptable?

(i.e.\20 % short term and\30 % long term with no

substantial bias)

J. Was the timing of outcome assessment in all groups

similar?

K. Did the analysis include an intention-to-treat

analysis?

Total items scored yes (0–11) /11

Curr Phys Med Rehabil Rep (2013) 1:197–215 209

123

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Ta

ble

4S

tud

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dre

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gs

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nt)

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tho

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ary

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ct

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ick

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can

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un

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rov

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allo

win

g

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t=

oro

mo

tor

exer

cise

’s,

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[39

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210 Curr Phys Med Rehabil Rep (2013) 1:197–215

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Ta

ble

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on

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/day

/3w

eek

s]

(i)

Cli

nic

alsw

allo

win

gab

ilit

y[M

AS

A]a

(ii)

Ora

lin

tak

e[F

OIS

]

(iii

)B

od

yw

eig

ht

(iv

)D

ysp

hag

ia-r

elat

edco

mp

lica

tio

n

(v)

Ret

urn

top

re-s

tro

ke

die

t

(vi)

Pat

ien

tp

erce

pti

on

of

swal

low

[Mea

sure

men

tb

asel

ine,

po

sttr

eatm

ent

and

3m

on

ths

foll

ow

ing

trea

tmen

t]

MA

SA

sco

rea,

FO

ISsc

ore

po

st

trea

tmen

tan

dp

rop

ort

ion

of

trea

tmen

tre

spo

nd

ersa

(ret

urn

top

re-

stro

ke

die

t)si

gn

ifica

ntl

yim

pro

ved

for

the

sham

arm

than

exp

erim

enta

l

or

con

tro

l.N

od

iffe

ren

cein

pat

ien

t

per

cep

tio

no

fsw

allo

wb

etw

een

inte

rven

tio

nan

dsh

amg

rou

ps

Mea

nst

and

ard

ized

dif

fere

nce

)M

AS

A

sco

re)a

Co

hen

’sd

=0

.25

(95

%C

I-

0.4

to0

.94

)

Bin

ary

pro

po

rtio

n

com

par

iso

n(r

esp

on

se)

Co

hen

’sd

=1

.7

(95

%C

I0

.4–

3)

Inte

rven

tio

nty

pe

=p

reve

nta

tive

beh

avi

ora

lex

erci

se

Car

nab

y-M

ann

etal

.

[19]b

(a)

Pro

ph

yla

ctic

swal

low

ing

exer

cise

du

rin

g

CR

T=

ph

ary

ng

oci

se

(b)

Sh

amsw

allo

win

g

exer

cise

du

rin

gC

RT

[Ph

ary

ng

oci

se=

effo

rtfu

l

swal

low

,to

ng

ue

pre

ss,

fals

etto

,ja

wst

ren

gth

enin

g

(Th

erab

ite)

](4

5m

ins/

29

day

/5d

ays/

6w

eek

s)

No

pre

ven

tati

ve

exer

cise

(i)

T2

wei

gh

ted

MR

Ia

(ii)

Fu

nct

ion

alsw

allo

win

g(M

AS

A

?F

OIS

)

(iii

)T

aste

sco

res

(iv

)S

mel

l

(v)

Sal

ivat

ion

(vi)

Bo

dy

wei

gh

t

(vii

)M

ou

tho

pen

ing

[Mea

sure

men

tb

asel

ine,

CR

Tco

mp

leti

on

,

6m

on

ths

afte

rC

RT

]

Pro

ph

yla

ctic

exer

cise

Inte

rven

tio

n

gro

up

dem

on

stra

ted

sup

erio

r

pre

serv

atio

nin

T2

MR

Isc

ore

s,

fun

ctio

nal

swal

low

ing

,m

ou

th

op

enin

gta

ste

and

sali

vat

ion

Mea

nst

and

ard

ized

dif

fere

nce

(t2

val

ue

my

loh

yo

id)a

Co

hen

’sd

=-

0.3

6

(95

%C

I-

0.0

98

to

0.2

6)

van

der

Mo

len

etal

.

[16]

Pro

ph

yla

ctic

swal

low

ing

exer

cise

=sw

allo

win

g

wit

hT

her

abit

ein

pla

ce?

swal

low

ing

wit

h

ton

gu

eel

evat

ed

[8–

12

rep

s,3

9d

aily

for

10

wee

ks]

Sta

nd

ard

ther

apy

=g

arg

leta

sk,

ora

lst

retc

hin

g,

mas

ako

,su

pr-

sup

rag

lott

ic,

forc

efu

l

bit

ing

man

euv

ers

[8–

12

rep

s,3

9d

aily

for

10

wee

ks]

(i)

Pen

etra

tio

n–

asp

irat

ion

scal

e[n

on

val

idat

ed]

(ii)

Max

imu

min

ciso

rd

ista

nce

(iii

)B

od

ym

ass

ind

ex

(iv

)F

OIS

sco

re

(v)

QO

Lsu

rvey

[Mea

sure

men

tb

asel

ine

and

po

st

trea

tmen

t]

No

sig

nifi

can

td

iffe

ren

ces

bet

wee

n

gro

up

s

On

lyp

re-

top

ost

-in

terv

enti

on

(wh

ole

gro

up

)re

sult

sp

rese

nte

d

Pat

ien

tsin

inte

rven

tio

nar

mp

ract

iced

less

oft

enb

ut

ob

tain

edco

mp

arab

le

resu

lts

No

qu

anti

tati

ve

resu

lt

com

par

iso

nav

aila

ble

bet

wee

ng

rou

ps

(fo

r

any

ou

tco

me)

insu

ffici

ent

stat

isti

cs

Ko

tzet

al.

[17]

Pro

ph

yla

ctic

swal

low

ing

exer

cise

du

rin

g

CR

T=

effo

rtfu

lsw

allo

w,

ton

gu

eb

ase

retr

acti

on

,

Mas

ako

,su

per

-

spu

rag

lott

ic,

men

del

soh

ns

man

euv

ers

[30

min

s/3

9d

aily

for

7w

eek

sat

ho

me

on

ow

n]

Usu

alca

re=

no

exer

cise

s

(i)

Per

form

ance

stat

us

scal

eH

N

[PS

SH

&N

eati

ng

inp

ub

lic

scal

e]a

(ii)

FO

ISsc

ale

[Mea

sure

men

tb

asel

ine,

7w

eek

sp

ost

trea

tmen

t,3

,6

,9

,1

2m

on

ths]

No

sig

nifi

can

td

iffe

ren

ceb

etw

een

sco

res

po

sttr

eatm

ent.

Sco

res

on

bo

thsc

ales

dem

on

stra

ted

sig

nifi

can

t

dif

fere

nce

sat

3an

d6

mo

nth

sb

ut

no

tat

late

rti

me

po

ints

No

qu

anti

tati

ve

resu

lt

com

par

iso

nav

aila

ble

bet

wee

ng

rou

ps

(fo

r

any

ou

tco

me)

insu

ffici

ent

stat

isti

cs

Curr Phys Med Rehabil Rep (2013) 1:197–215 211

123

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Ta

ble

4co

nti

nu

ed

Au

tho

rIn

terv

enti

on

met

ho

do

log

yC

on

tro

lm

eth

od

olo

gy

Ev

alu

atio

nm

easu

res

Mai

nfi

nd

ing

sP

rim

ary

effe

ct

calc

ula

tio

n

Car

nab

yet

al.

[22

]b(a

)Pro

ph

yla

ctic

swal

low

ing

exer

cise

-th

erap

ist

dir

ecte

d=

Ph

ary

ng

oci

se

(b)P

rop

hy

lact

icsw

allo

win

g

exer

cise

-pat

ien

td

irec

ted

[45

min

s/2

9d

ay/5

day

s/

6w

eek

s]

Usu

alca

re=

no

exer

cise

s

(i)

T2

MR

I

(ii)

MA

SA

-C

(iii

)F

OIS

(iv

)S

WA

LQ

OL

(v)

Bo

dy

wei

gh

t

(vi)

Psy

cho

-so

cial

mea

sure

s

(vii

)C

om

pli

ance

wit

hex

erci

se

[Mea

sure

men

tb

asel

ine,

po

sttr

eatm

ent,

3-m

on

ths

foll

ow

ing

trea

tmen

t]

Les

ssw

allo

wm

usc

led

eter

iora

tio

n,

less

fun

ctio

nal

swal

low

chan

ge

and

gre

ater

com

pli

ance

iden

tifi

edin

the

ther

apis

td

irec

ted

arm

com

par

edto

pat

ien

td

irec

ted

or

con

tro

l

Mea

nst

and

ard

ized

dif

fere

nce

(len

gth

my

loh

yo

id)

Co

hen

’sd

=0

.51

(95

%C

I0

.03

–0

.99

)

aD

eno

tes

pri

mar

yo

utc

om

efo

ref

fect

size

calc

ula

tio

nb

Den

ote

sh

igh

-gra

de

RC

T

Ta

ble

5S

tud

ych

arac

teri

stic

san

dre

lev

ant

fin

din

gs

(co

nt)

Auth

or

Inte

rven

tion

met

hodolo

gy

Contr

ol

met

hodolo

gy

Eval

uat

ion

mea

sure

sM

ain

findin

gs

Pri

mar

yef

fect

calc

ula

tion

Inte

rven

tion

type

=beh

avi

ora

lm

aneu

vers

/com

pen

sati

ons

plu

salt

ernati

vem

edic

ine

Fen

get

al.

[29

]T

ongyan

spra

y?

mix

edsw

allo

w

ther

apy

=R

OM

,m

odifi

eddie

ts,

ice

stim

ula

tion

[39

day

/28

day

s]

Pla

cebo

Tongyan

spra

y?

mix

ed

swal

low

ther

apy

=R

OM

,

modifi

eddie

ts,

ice

stim

ula

tion

[39

day

/28

day

s]

(i)

Sta

ndar

dsw

allo

win

g

asse

ssm

ent

scal

e

[Non-v

alid

scal

e]

[Mea

sure

men

tbas

elin

e,post

28

day

s]

Inte

rven

tion

gro

up

show

ed

signifi

cantl

ym

ore

impro

vem

ent

on

SS

Asc

ale

than

contr

ol

post

trea

tmen

t

Chan

etal

.[3

0]

Acu

punct

ure

?sw

allo

wth

erap

y=

oro

moto

r

exer

cise

s?

man

euver

s?

die

t

modifi

cati

on

?posi

tionin

g?

com

pen

sati

ons

[1.5

month

sof

20

sess

ions]

(1)

Sham

acupunct

ure

?sw

allo

w

ther

apy

[1.5

month

sof

20

sess

ions]

(2)

Routi

ne

care

(non-r

andom

ized

gro

up)

(i)

Royal

Bri

sban

eH

osp

ital

outc

om

em

easu

resc

ore

(ii)

Food

/fluid

sco

nsu

med

[Mea

sure

men

tbas

elin

e,w

eek

2,

wee

k4,

3m

onth

spost

trea

tmen

t]

Exper

imen

tal

gro

up

dem

onst

rate

d

signifi

cantl

yhig

her

RB

HO

M

score

saf

ter

18

wee

ks

than

contr

ol

gro

up

2

Sham

show

edsi

gnifi

cantl

yhig

her

RB

HO

Msc

ore

saf

ter

18

wee

ks

than

contr

ol

gro

up

2

Exper

imen

tal

gro

up

dem

onst

rate

d

signifi

cantl

ygre

ater

food

fluid

consi

sten

cies

consu

med

212 Curr Phys Med Rehabil Rep (2013) 1:197–215

123

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Ta

ble

5co

nti

nu

ed

Auth

or

Inte

rven

tion

met

hodolo

gy

Contr

ol

met

hodolo

gy

Eval

uat

ion

mea

sure

sM

ain

findin

gs

Pri

mar

yef

fect

calc

ula

tion

Yan

get

al.

[28

]A

nodal

tran

scra

nia

ldir

ect

curr

ent

(tD

CS

)[1

mA

for

20

min

/dai

lyfo

r

10

day

s]?

conven

tional

swal

low

trai

nin

g(n

odet

ails

pro

vid

ed)

Sham

tDC

S[1

mA

for

30

s/dai

lyfo

r

10

day

s]?

conven

tional

swal

low

trai

nin

g(n

odet

ails

pro

vid

ed)

(i)

VF

SS

-bio

mec

han

ics

[OT

T,

PT

T,

TT

T]

(ii)

Funct

ional

dysp

hag

iasc

ale

[FD

S]

[Mea

sure

men

tbas

elin

e,post

trea

tmen

t

and

3m

onth

spost

trea

tmen

t]

No

dif

fere

nce

inF

DS

score

spost

trea

tmen

t.A

t3-m

onth

spost

inte

rven

tion

dem

onst

rate

dim

pro

ved

FD

Ssc

ore

sco

mpar

edto

sham

Inte

rven

tion

type

=pro

gra

mef

fect

iven

ess

Mid

dle

ton

etal

.

[14

]bM

ult

idis

cipli

nar

ytr

eatm

ent

pro

toco

lfo

r

fever

,hyper

gly

cem

iaan

dsw

allo

win

g

man

agem

ent

[Pro

toco

lspro

vid

ed3

month

spri

or

to

dat

aco

llec

tion]

Abri

dged

curr

ent

guid

elin

es

only

(i)

Modifi

edra

nk

insc

ore

(mR

S)a

(ii)

Bar

thel

index

(iii

)S

F-3

6pysi

cal

com

ponen

t

(iv)

SF

-36

men

tal

com

ponen

t

[Mea

sure

men

tpre

and

post

90

day

s

from

adm

issi

on]

Pat

ients

trea

ted

inin

terv

enti

on

AS

U

less

likel

yto

be

dea

dor

dep

enden

t

(mR

Ssc

ore

)an

dbet

ter

SF

-36

physi

cal

score

sth

anco

ntr

ol

gro

up

Bin

ary

pro

port

ion

com

par

ison

a

Cohen

’sd

=-

0.3

5(9

5%

CI

-0.4

9to

0.2

1)

Inte

rven

tion

type

=beh

avi

ora

lm

aneu

vers

/com

pen

sati

ons

Tan

get

al.

[15

]R

ehab

ilit

atio

nth

erap

y-t

ongue,

phar

ynx,l

arynx

exer

cise

?R

OM

tris

mus

(Ther

abit

e)

[39

day

/45

cycl

esfo

r3

month

s]

Routi

ne

trea

tmen

t=

no

exer

cise

?an

ti-

infl

amm

atory

trea

tmen

t

(i)

Wat

ersw

allo

wte

stsc

ore

(ii)

Inci

sor

dis

tance

(len

tso

ma

score

)

[Mea

sure

men

tbas

elin

ean

dpost

trea

tmen

t]

Sig

nifi

cant

impro

vem

ent

insw

allo

w

score

inre

hab

gro

up,

signifi

cant

dec

reas

edin

inci

sor

dis

tance

in

contr

ol

gro

up

Oh

etal

.[1

8]

Rep

etit

ive

swal

low

wit

hto

ngue

hold

man

euver

[20

min

920

sess

ions

over

4w

eeks]

Sw

allo

win

gw

ithout

tongue

rest

rict

ion

[20

sess

ions

over

4w

eeks]

(i)

Bio

mec

han

ics

from

VF

SS

-

phar

yngea

lco

nst

rict

ion

rati

o,

max

imum

hyo-l

aryngea

lm

ovem

ent,

,

post

erio

rphar

yngea

lw

all

movem

ent

[Mea

sure

men

tbas

elin

ean

dpost

trea

tmen

t]

No

signifi

cant

dif

fere

nce

inef

fect

bet

wee

ngro

ups

No

quan

tita

tive

resu

lt

com

par

ison

avai

lable

bet

wee

ngro

ups

(for

any

outc

om

e)—

insu

ffici

ent

stat

isti

cs

Ter

reet

al.

[27

]C

hin

dow

nposi

tion

under

vid

eofl

uoro

scopy

Anat

om

icposi

tion

under

vid

eofl

uoro

scopy

(i)

Asp

irat

ion

(?/-

)fr

om

VF

SS

(ii)

Bio

mec

han

ics

from

VF

SS

[OT

T,

PT

T,

PD

T]

[Mea

sure

men

tpre

-post

alte

rnat

ing

VF

SS

mea

sure

s]

Inas

pir

atin

gsu

bje

cts

only

50

%

avoid

edas

pir

atio

nusi

ng

chin

dow

n

posi

tion

(pre

-sw

allo

wor

duri

ng

swal

low

)

No

contr

ol

com

par

ison

could

be

report

ed

Inte

rven

tion

type

=beh

avi

ora

lex

erci

ses

Tro

che

etal

.[2

6]

Expir

atory

musc

lest

rength

trai

nin

g

[EM

ST

]

[75

%m

axim

um

for

5se

ts/5

repet

itio

ns/

5day

sfo

r4

wee

ks]

Sham

EM

ST

[5se

ts/5

repet

itio

ns/

5day

sfo

r

4w

eeks]

(i)

Pen

etra

tion–as

pir

atio

nsc

ore

[Non-v

alid

ated

scal

e]

(ii)

SW

AL

QO

Lsc

ore

s

(ii)

Hyoid

,U

ES

movem

ent

[Mea

sure

men

tbas

elin

ean

dpost

trea

tmen

t]

Inte

rven

tion

gro

up

show

edim

pro

ved

pen

etra

tion

score

s,S

WA

LQ

OL

score

shyoid

movem

ent

and

UE

S

open

ing

dia

met

erco

mpar

edto

sham

Curr Phys Med Rehabil Rep (2013) 1:197–215 213

123

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Dissemination, 2008. ISBN 978-1-900640-47-3. Accessed 18

June 2013.

2. Stanley K. Design of randomized controlled trials. Circulation.

2007;115:1164–9.

3. Tate D. The state of rehabilitation research: art or science? Arch

Phys Med Rehabil. 2006;87:160–6.

4. Tucker J, Reed G. Evidentiary pluralism as a strategy for research

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