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Feasibility of an individualised, task-oriented, video-supported home exercise programme for arm function in patients in the subacute phase after stroke: protocol of a randomised controlled pilot study

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Introduction Stroke rehabilitation guidelines suggest a high-frequency task-oriented training at high intensity. A targeted and self-paced daily training with intermittent supervision is recommended to improve patients’ self-management and functional output. So far, there is conflicting evidence concerning the most effective home-training delivery method. Methods and analysis The purpose of this pilot study is to compare the feasibility and preliminary effects of task-oriented home-exercises in patients in the subacute stage after stroke. Twenty-four patients will be randomised (1:1) to a Video group (a) or Paper group (b) of an individualised, task-oriented home-training (50 min, 6×/week, for 4 weeks) based on Wulf and Lewthwaite’s Optimizing Performance Through Intrinsic Motivation and Attention for Learning theory of motor learning. Patient-relevant goals will be identified using Goal Attainment Scaling and exercises progressively adapted. Semistructured interviews and a logbook will be used to monitor adherence, arm use and acceptability. Primary outcome will be the feasibility of the methods and a full-scale trial employing predefined feasibility criteria (recruitment, retention and adherence rates, patients’ satisfaction with the home-exercise programme and their progress, affected hand use and acceptance of the intervention). Assessed at baseline, post intervention and 4-week follow-up, secondary outcomes include self-perceived hand and arm use, actual upper extremity function and dexterity, hand strength, independence in activities of daily living and health-related quality of life. Interview data will be analysed using qualitative content analysis. Medians (ranges) will be reported for ordinal data, means (SD) for continuous and frequency (percentage) for nominal data. Ethics and dissemination This study follows the Standard Protocol Items: Recommendations for Interventional Trials-Patient-Reported Outcome (PRO) Extension guideline. Ethical approval was received from the Ethics Committee of the Medical University of Innsbruck, Austria (1304/2020). Written informed consent will be obtained from all participants prior to data collection. Study results will be disseminated to participating patients, patient organisations, via the clinic’s homepage, relevant conferences and peer-reviewed journals. Trial registration number DRKS-ID: DRKS00023395. Study protocol, second revision, 5 December 2021.
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1
WannerM, etal. BMJ Open 2022;12:e051504. doi:10.1136/bmjopen-2021-051504
Open access
Feasibility of an individualised, task-
oriented, video- supported home exercise
programme for arm function in patients
in the subacute phase after stroke:
protocol of a randomised controlled
pilot study
Miriam Wanner,1 Gudrun Schönherr,1 Stefan Kiechl,1 Michael Knoach,1
Christoph Müller,1 Barbara Seebacher 1,2
To cite: WannerM,
SchönherrG, KiechlS, etal.
Feasibility of an individualised,
task- oriented, video- supported
home exercise programme for
arm function in patients in the
subacute phase after stroke:
protocol of a randomised
controlled pilot study. BMJ Open
2022;12:e051504. doi:10.1136/
bmjopen-2021-051504
Prepublication history and
additional supplemental material
for this paper are available
online. To view these les,
please visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2021-051504).
Received 21 March 2021
Accepted 14 December 2021
1Clinical Department of
Neurology, Medical University of
Innsbruck, Innsbruck, Austria
2Research Centre on Vascular
Ageing and Stroke, VASCage,
Innsbruck, Austria
Correspondence to
Dr Barbara Seebacher;
barbara. seebacher@ i- med. ac. at
Protocol
© Author(s) (or their
employer(s)) 2022. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Introduction Stroke rehabilitation guidelines suggest a
high- frequency task- oriented training at high intensity. A
targeted and self- paced daily training with intermittent
supervision is recommended to improve patients’ self-
management and functional output. So far, there is
conicting evidence concerning the most effective home-
training delivery method.
Methods and analysis The purpose of this pilot study is
to compare the feasibility and preliminary effects of task-
oriented home- exercises in patients in the subacute stage
after stroke. Twenty- four patients will be randomised (1:1)
to a Video group (a) or Paper group (b) of an individualised,
task- oriented home- training (50 min, 6×/week, for 4
weeks) based on Wulf and Lewthwaite’s Optimizing
Performance Through Intrinsic Motivation and Attention
for Learning theory of motor learning. Patient- relevant
goals will be identied using Goal Attainment Scaling
and exercises progressively adapted. Semistructured
interviews and a logbook will be used to monitor
adherence, arm use and acceptability. Primary outcome
will be the feasibility of the methods and a full- scale trial
employing predened feasibility criteria (recruitment,
retention and adherence rates, patients’ satisfaction
with the home- exercise programme and their progress,
affected hand use and acceptance of the intervention).
Assessed at baseline, post intervention and 4- week
follow- up, secondary outcomes include self- perceived
hand and arm use, actual upper extremity function and
dexterity, hand strength, independence in activities of daily
living and health- related quality of life. Interview data will
be analysed using qualitative content analysis. Medians
(ranges) will be reported for ordinal data, means (SD) for
continuous and frequency (percentage) for nominal data.
Ethics and dissemination This study follows the
Standard Protocol Items: Recommendations for
Interventional Trials- Patient- Reported Outcome (PRO)
Extension guideline. Ethical approval was received
from the Ethics Committee of the Medical University
of Innsbruck, Austria (1304/2020). Written informed
consent will be obtained from all participants prior to
data collection. Study results will be disseminated to
participating patients, patient organisations, via the clinic’s
homepage, relevant conferences and peer- reviewed
journals.
Trial registration number DRKS- ID: DRKS00023395.
Study protocol, second revision, 5 December 2021.
INTRODUCTION
Stroke is a devastating disease and second
most prevalent cause of disability in the
European Union, with more than 1.1 million
people being affected every year.1 Survi-
vors with mild to moderate stroke are often
disabled in motor function, in their activities
of daily living (ADL) and experience a loss in
social participation which influences quality
of life.2 As many as 50%–80% of patients
after stroke (PaS) have impaired upper limb
function3–5 and are in need of rehabilitation
services. During rehabilitation, a discrepancy,
however, is frequently seen between their
Strengths and limitations of this study
The intervention groups of this study will receive a
home exercise programme, based on relevant motor
learning and action observation principles.
Both subjective and objective assessments will be
used in this study to assess hand and arm function
and use in daily life in people after stroke.
This pilot study will employ a mixed methods ap-
proach and a range of predened feasibility criteria.
Throughout this study, patient involvement is con-
sidered essential to target the intervention to pa-
tients’ needs and preferences.
The sample size of this pilot and feasibility study
is too small to examine the effectiveness of the
intervention.
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Open access
level of upper limb capacity and actual use in daily life
activities.6 7
According to international stroke rehabilitation guide-
lines8 9 and systematic reviews,10 11 various evidence-
based treatment strategies and programmes for the
upper extremity are recommended. Shared characteris-
tics of successful programmes are a high intensity, high
repetition rate and a task- oriented training approach
within a minimum period of 6 months post stroke; this
includes home- based practice to enhance the training
frequency.8 10–12 Contrastingly, a Cochrane review and
meta- analysis (2012) has failed to identify a sufficiently
large number of high- quality studies, which investigated
the effects of home- based upper limb training on ADL
performance or functional arm movement after upper
extremity training.13 A systematic review (2020) showed
that existing self- administered home- based practice is not
superior to no intervention on upper limb activity and
structured home- based practice is similarly effective as
non- structured home- based practice in chronic, severely
disabled stroke survivors.14
These results suggest that a home- based training needs
to comply with relevant motor learning principles in
order to be effective. According to Wulf and Lewthwaite’s
‘Optimizing Performance Through Intrinsic Motivation
and Attention for Learning’ (OPTIMAL) theory of motor
learning,15 there are three evidence- based key elements
which boost motor learning: enhanced outcome expec-
tancy, learner’s autonomy and an external focus of
attention. The combined approach has been found
most effective due to the additive contributions of key
factors.16 17
Rehabilitation guidelines suggest a targeted and
self- paced daily training with intermittent supervision
including a close monitoring of training adherence.18
Various behavioural strategies have been recommended,
for example, a joint goal setting, specific feedback and
continuous support and monitoring via phone calls.19 20
Modern technology is increasingly being used to increase
patients’ autonomy during client- specific and task- specific
interventions.21 It has been shown to encourage patients’
self- management22–24 and increase the therapy frequency
in the subacute phase after stroke.10 25 26 For example,
action observation therapy combines video- based move-
ment observation with actual performance of the same
task- specific exercises.27
So far, there is controversial evidence concerning the
effects of a video- supported home training as compared
with conventional home- based training in the stroke
population. In PaS, one study did not find any differ-
ences between these two interventions on adherence,
upper limb function and patient satisfaction28 whereas
others observed a superiority of video- based training on
patients’ independence with ADL29 and upper extremity
performance in daily life.30 Recent work has shown
greater improvements in adherence, self- efficacy for exer-
cises, mobility but not basic ADL after video- based when
compared with paper- based home training in PaS.31 A
cross- sectional study reported the preference of patients
receiving hand therapy of a video- based over a paper-
based home training programme. Reported reasons
were the more appealing design and patients’ greater
understanding and confidence in their ability to correctly
perform the tasks.32 None of these studies have however
incorporated OPTIMAL motor learning principles in the
training.
OBJECTIVES
The purpose of this pilot study is, therefore, to explore
the feasibility of an individualised, task- oriented, video-
based versus a paper- based home exercise programme
based on the latest principles of the OPTIMAL theory of
motor learning15 in PaS in the subacute stage with mild
to moderate arm paresis. A further aim is to compare
the preliminary effects of the video- based with the paper-
based home exercise programme on the paretic upper
limb use in meaningful activities of daily life, in order to
calculate the sample size for a full- size trial.
METHODS AND ANALYSIS
Study design, setting and timeline
The study is designed as a single- centre, randomised,
parallel- group, assessor- blinded controlled pilot and
feasibility trial in people after a first- ever stroke and
follows the Standard Protocol Items: Recommendations
for Interventional Trials (SPIRIT) 2013 and SPIRIT- PRO
Extension Checklist (online supplemental file 1). This
study will be conducted at the Clinical Department of
Neurology, Medical University of Innsbruck, Austria. The
patient’s exercise programme will be performed at home.
The expected overall study duration is approximately 12
months, from 1 April 2021 to 30 April 2022.
Patient and public involvement
No patients were involved in the development of the
study design and methods. Throughout this study, patient
involvement is considered essential to target the interven-
tion to patients’ needs and preferences. Patients’ perspec-
tives on the intervention will be asked for during weekly
phone call interviews and semistructured interviews at
post intervention. The planned study intervention will be
modified based on these findings.
Patients and sample size
Inclusion and exclusion criteria
Patients have to meet the inclusion criteria as follows:
first- ever stroke leading to a mild to moderate arm
paresis as assessed by the Motricity Index (MI) (includes
a minimum pinch grip of 19 points and elbow flexion/
shoulder abduction of 14 points and excludes normal
scores of 33), in the subacute stage (from 7 days to
5 months after a stroke), age of >18 years, sufficient
cognitive abilities (Mini Mental Status Test2433), living
in Tyrol, discharged from the hospital and living at home.
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Open access
People are excluded if they are severely disabled (modi-
fied Rankin Scale (mRS) score 434), have a comorbidity
potentially restraining participation, for example, a life
expectancy <12 months or malignant disease, any physical
or mental condition restricting participation in the study,
for example, heart failure, being under guardianship,
serious neuropsychological disorders, neglect, severe
aphasia, severe cognitive deficits or dementia, psychiatric
disorders, haemianopia, untreated severe visual impair-
ment (ie, problems reading instructions and watching the
study videos), pregnancy, military service. The study prin-
ciple investigator (PI) will decide whether a participation
in other studies is allowed.
The sample size for this pilot and feasibility study has
been determined to include a number of 12 patients per
group, as previously recommended.35
Recruitment and informed consent
Patients treated at the Clinical Department of Neurology
at the Medical University of Innsbruck, Austria due to a
first- ever stroke will be identified and checked for eligi-
bility. The PI will inform patients about the study both
orally and in writing. Eligible patients who provide their
written informed consent will be enrolled into the study.
Patients will be assured that their consent is voluntary,
and they may withdraw from the study at any time without
reasons and without treatment prejudice (online supple-
mental files 2 and 3).
Randomisation, allocation concealment and blinding
Stratified (for age: 70 and under, over 7036) blocked rando-
misation will be conducted with a software- based random
number generator (Sealed Envelope, London, UK) by an
independent researcher (BS) using permuted blocks of 2
and 4, allocation concealment and 1:1 allocation. Study
results will be reported in accordance with the Consoli-
dated Standards of Reporting Trials (CONSORT).37 38 A
flow diagram is shown in online supplemental figure 1.
Allocation concealment will be performed to avoid allo-
cation bias. Based on the randomisation list, sequentially
numbered sealed opaque envelopes including group
allocation letters V (Video group) and P (Paper group)
will be created for the stratum of age. A unique identifi-
cation number (ID) will be given to patients who will be
asked to unseal the envelopes themselves and not discuss
their group allocation until study completion. Assessors
will be blinded to the group allocation of patients and
will be asked on a random basis about their assumption
concerning the group allocation of a patient. Blinding
will be considered preserved if their guessing is correct
in around 50% of responses, which is consistent with
random guessing.39 Patients will not be aware of the study
hypotheses. Unplanned unblinding will be done in cases
of emergency.
Intervention
Based on existing evidence showing that a higher dose
of exercises facilitates motor recovery after stroke,40 two
intervention groups will be used in this study, in addition
to usual care:
Video group: patients will receive an Android tablet
with access to the exercise platform where videos are
available, based on existing studies of action observa-
tion27 as shown in figure 1. The therapist will adjust
the therapy goals, number of repetitions of the indi-
vidual exercises, respective videos and instructions
on a weekly basis. Adjustments regarding the exer-
cise difficulty will be based on whether the intended
goals and number of repetitions have been achieved.
Patients will be invited to record the desired number
of repetitions and actual number of repetitions, daily
exercise duration, evaluate how they fared with the
individual exercises and finally, their overall satisfac-
tion and (self-) management in the logbook.
Paper group: patients will receive a folder with photos
and instructions for the home exercise programme
including a logbook. Based on a weekly telephone
conversation with the occupational therapist, they
are asked to enter a jointly agreed weekly goal and
desired number of repetitions, the actual number of
repetitions, daily exercise duration and evaluate how
they fared with the individual exercises and finally,
their overall satisfaction and (self- )management in
the logbook.
The intervention will involve an individualised, task-
oriented home exercise programme oriented on motor
learning and task- specific exercise programmes for
PaS41–47 and on the principles of the OPTIMAL theory
(table 1), delivered either video- based (Video group)
or paper- based (Paper group). The intervention will be
offered by an experienced occupational therapist (MW)
as an add- on to usual outpatient rehabilitation and
performed six times per week, 50 min per session for 4
weeks. Before the start of the home exercise programme,
two questions will be asked on self- confidence (‘How
confident are you in doing the 4- week home exercise
programme?’) and support of the environment (‘Can
people in your home environment support you in your
training?’), and one patient- relevant goal will be agreed
on for the first week using Goal Attainment Scaling (GAS).
Exercises will be selected individually from a predesigned
list/menu. All patients will be called by an occupational
Figure 1 Key aspects of task- oriented training in the Video
group.
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Open access
therapist (MW) once a week (four times in total) who
will provide support, identify any problems and evaluate
adherence with structured questions (figure 2), define
patient- relevant goals using GAS and adapt the exercises.
Data collection
Demographic (gender, age, date of birth) and
stroke specific data (type and date of insult, previous
neurorehabilitation based on current event, current
outpatient therapy, patient- reported handedness, contex-
tual factors such as life and employment situation) will
be extracted from patients’ charts at eligibility screening,
followed by a screening for an impairment in upper limb
and cognitive functions (MI; Mini Mental Status Test).
Study specific outcome data will be collected at baseline
(t1), post intervention (t2) and at 4- week follow- up (t3)
by three blinded occupational therapists. These assessors
will be trained before the start of the data collection.
Assessments will be collected at random to avoid an order
effect. Semistructured interviews will be performed by the
intervention provider (MW) at t2 to gain in- depth infor-
mation concerning acceptability of the study intervention
(online supplemental table 1).
Adverse events will be monitored throughout the study
and cared for. A logbook, platform recording and infor-
mation gained from structured questions during weekly
phone calls will be used to monitor adherence to the
home- exercise programme. A schedule of enrolment,
intervention and data collection during the study is
shown in online supplemental table 2.
Primary outcome
The feasibility of the methods and of conducting a full-
scale randomised controlled trial (RCT) will be explored
using predefined feasibility criteria.
Table 1 Principles of the Optimizing Performance Through Intrinsic Motivation and Attention for Learning theory adapted to
this study
Motivational effects—
enhanced performance expectancies Autonomy support
Attentional effects—
external focus of attention
Patients’ encouragement regarding the learnability of
the tasks at the programme start
Choice of the numbers of
repetitions and sets
Exercises have a specic goal and are
task- oriented
Conversation about previous positive outcomes, to
enhance expectations of the programme.
Choice of the exercise sequence Objects or markings which should be
reached, drawing attention to the planned
effect of a movement on the environment
General information on performance improvement
alongside practice.
Choice of the difculty level Instructions focusing on the task goal,
using metaphors or analogies as guidance
Explanatory model of neuroplasticity, motor learning
and normative information provided on the platform or
in the exercise folder.
Shaping, that is, a gradual
increase in difculty, adjusting one
parameter at a time (eg, size or
weight of an object)
Variability in the order of the exercises,
random practice of the exercise
Realistic weekly goals evaluated through Goal
Attainment Scaling.
Choice of an exercise- free day
Weekly semistructured interview of the process to
identify problems and progress related to arm use,
level of support needed and programme satisfaction.
Choice of the amount of feedback
Positive feedback of good performance, suggestive
statement on better than average performance for
example, ‘you are doing well’, ‘active people with your
experience usually do well with this task’.
Individual goal setting through
Goal Attainment Scaling
Progression of exercises based on weekly goals
which are challenging, but achievable to provide
experiences of success
Evaluation of the exercises using
smileys (5- point Likert- Scale)
Report of previously trained minutes
Figure 2 Questions asked in weekly semistructured
interviews.
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Open access
A logbook will be used to report adherence to the
home exercise programme. Any non- adherence or non-
retention (attrition) will be recorded including its reason
and will be presented in a CONSORT flow diagram
(online supplemental figure 1).
Feasibility criteria include (1) a target recruitment
rate of 6% out of 450 eligible patients (or 2–3 patients
per month). The number of 450 patients was estimated
according to the number of people after stroke meeting
the eligibility criteria at the study centre within the
previous 12- month period and the recruitment rate based
on the number of patients being discharged home, (2) a
target retention rate of 80% (or 20 patients), (3) a target
minimum adherence rate of 67% (4 home- based training
sessions per week out of a maximum of 6), (4) an at least
moderate satisfaction with one’s individual exercise prog-
ress (3.5 out of 5 points on a Smiley Face Likert Scale,
from 1=very unsatisfied to 5=very satisfied), (5) an at least
moderate use of the affected hand in ADL and satisfaction
with one’s progress and the home exercise programme
(60 points on a Numeric Rating Scale (NRS) from 0 to
100) and (6) an at least moderate acceptance of the inter-
vention as evaluated by a semi- structured interview.
Secondary outcomes
Self-perceived arm and hand use arm function
A change in self- perceived arm and hand function will
be measured by the German Motor Activity Log- 30
(MAL- 30),48 a semistructured interview that scores the
perceived amount of use and perceived quality of move-
ment (QOM) in 30 ADL tasks, using a 6- point scale
ranging from 0 (arm not used during activity; no satisfac-
tion with QOM) to 5 (arm used as much as prestroke; full
satisfaction with QOM). The German version is a valid,
reliable and highly responsive assessment.48 Minimal clin-
ically important difference (MCID) values for the MAL
were 1.0 and 1.1 points for the affected dominant and
non- dominant hands, respectively.49
Arm motor function
Upper limb function will be assessed by the 19- item
Action Research Arm Test (ARAT).50 The ARAT uses
movement observation and consists of 4 subtests (grasp,
grip, pinch, gross arm movement), which are rated on a
4- point ordinal scale (0=can perform no part of test to
3=perform test normally). The ARAT has excellent test–
retest and intrarater and inter- rater reliability and internal
consistency.50 51 MCID for the ARAT in acute stroke is 12
points if the dominant side is affected and 17 points if the
non- dominant side is affected.52
Finger dexterity
Manual dexterity will be assessed by the Nine Hole Peg
Test (NHPT),53 where pegs are to be placed into the holes
of a board and returned to the container as quickly as
possible. Timing will be determined using a stopwatch
and recorded in seconds, with shorter durations indi-
cating better dexterity. Normative data for healthy adults
are available.53 The minimum detectable change (MDC)
is a reduction of time by 54%.52 Adequate to excel-
lent psychometric properties have been shown for the
NHPT.53 54
Gross motor arm and hand dexterity
The Box and Block Test (BBT)55 measures unilateral gross
motor dexterity of the arm and hand. As many blocks as
possible should be moved from one box compartment
to the other for a period of 60 s. The BBT is scored by
counting the numbers of blocks. Normative data are
available and higher scores indicate better gross manual
dexterity.55 MDC is 5,5 blocks per minute (18%) in acute
and chronic stroke.52 The BBT has shown excellent test–
retest and inter- rater reliability and adequate to excellent
criterion validity.54
Hand strength
The Jamar grip dynamometer is a quantitative and objec-
tive measure of isometric muscular strength of the hand
and forearm, scored using force production in kilograms
(0–90), with normative data available.56 The MCID of
Jamar grip dynamometer is 5.0 and 6.2 kg for the affected
dominant and non- dominant sides.49 The measure has
an excellent test–retest and intrarater reliability and
adequate validity.56
Independence in ADL
Scores of Independence for Neurologic and Geriatric
Rehabilitation (SINGER)57 based on the International
Classification of Functioning, Disability and Health
measures 20 aspects of ‘independence in ADL’. Items
are graded in six steps (0–5). The gradation refers to
the type and amount of help required for the respective
activity that is, 0=totally dependent on professional help
to 5=independent without assistive device. Good to excel-
lent psychometric properties and ceiling effects of 3.6%
have been demonstrated for the SINGER.57 58
ADL collectively describe fundamental skills needed for
self- care like eating, bathing and mobility.59
Health-related quality of life (HRQoL)
The EuroQol- 5 Dimensions 5- level (EQ- 5D- 5L) question-
naire60 measures five dimensions of HRQoL: mobility,
self- care, usual activities, pain/discomfort and anxiety/
depression. Responses are rated on five levels ranging
from 1=no problems to 5=extreme problems. The present
overall health is rated on a Visual Analogue Scale (VAS)
from 0 to 100.61 The MCID of the EQ- Index is 0.10 (33.8
%) based on an anchor- based approach, and 8.61 (41.5
%) for the VAS. The EQ- 5D- 5L has shown acceptable
psychometric properties in people post stroke under-
going rehabilitation.62
Individual goal achievement
The GAS is a scale to quantify the achievement of goals
set, which can be measured on a 5- point scale ranging
from −2 (much less) to +2 (much more).63 The GAS has
good validity, reliability and sensitivity.64
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Data management
Personal data are pseudonymised and handled strictly
confidentially, according to the Austrian Data Protec-
tion Law. All data are digitised in double entry. Data and
all study- related documents are stored safely at the trial
site for 15 years. Access is granted only to authorised
study team members. No data monitoring committee is
required in this academic study (no competing interests).
Statistical analyses
Descriptive statistics will be performed using IBM SPSS
software, V.26.0. Statistical significance is defined as two-
tailed p value of <0.05. To avoid missing data, patients will
be asked to complete missing responses in questionnaires.
Intention- to- treat analysis will be performed for all cases
with complete follow- up data, which are analysed by original
assigned groups. Descriptive statistics will be reported for all
outcomes. Continuous data will be checked for outliers and
normality using the Shapiro- Wilk test, histograms and Q–Q
plots. Medians (IQRs, ranges) will be reported for ordinal
data (mRS, MAL, ARAT, SINGER, EQ- 5D- 5L, NRS, GAS,
Smiley Face Likert Scale). Means (95% SD) will be reported
for continuous data (age, NHPT, BBT, muscle strength in
kg) and raw count (frequency, percentage) will be reported
for counted (N adverse events and missing data if any, eligi-
bility, recruitment, retention and adherence rates) and
nominal data (gender, lesion side, ischaemic/haemorrhagic
stroke, living alone/with partner and handedness).
The eligibility rate is the percentage of patients who are
eligible using the inclusion and exclusion criteria. The
recruitment rate (%) will be determined by dividing the
number of patients consented by the number of patients
eligible. The retention rate is the percentage of patients who
completed the study out of the total sample, times 100. The
adherence rate (%) is the percentage of actually performed
number of exercise sessions over the planned number of
exercise sessions, times 100.65 Eligibility and consent rates will
be calculated with 95% CIs according to the Wilson ‘score’
method cited by Newcombe.66 In the case of a proportion
close to 0 or 1, a Poisson approximation according to Brown
will be used.67
Preliminary effects will be evaluated: for ordinal vari-
ables, differences between post intervention and baseline
will be calculated, and between follow- up and baseline, and
between follow- up and post intervention. A Mann- Whitney
U test will be performed on these new variables. For contin-
uous data, a repeated measures analysis of variance will be
conducted if the assumption of sphericity is met, or correc-
tion procedures applied as appropriate. In the case of a
non- normal distribution, continuous data will be treated like
ordinal data. Corrections for multiple comparisons will be
performed as appropriate.
The sample size for a full- scale RCT will be calculated
using effect sizes for the Mann- Whitney U test (baseline,
post intervention)68 based on the group differences in self-
perceived arm use (MAL). The correlation coefficient r will
be estimated using the equation
r=Z
n
,69 where Z is the
standardised value for the U value and n is the total number
of observations on which Z is based. The r value will be
converted into r2, which is equivalent to a partial eta squared
effect size and (multiplied by 100) signifies the percentage
of variance in the dependent variable as explained by the
independent variable.68
Qualitative data analysis
Interview data will be analysed by Steigleder’s modified
variant of Mayring’s qualitative content analysis approach.70
Using a combined deductive–inductive approach, main-
content and subcontent categories will be developed, which
are continuously adapted according to the data material.
Interviews will be manually transcribed and analysed by
MAXQDA software (VERBI GmbH, Berlin, Germany).
Reoccurring ideas, concepts, words and phrases will be
identified and scrutinised. Based on that, a coding frame
will be developed to group them into meaningful categories.
Categories and subcategories are required to be mutually
exclusive and exhaustive, apparent one dimensional and
saturated. Saturation is reached after all the codes in the
population have been observed once in the sample.71 Rele-
vant material will be selected and text segments structured
and generated, marked and defined. Defined text segments
will then be subdivided, revised and expanded and central
subcategories identified, based on the research question.72 73
Categories will be defined, named and characterised, and
decision rules defined for any cases of overlapping subcate-
gories, to allow for a consistent assignment of data segments.
The material will progressively be summarised, subsumed
and contrasted. Categories and subcategories will be illus-
trated using citations. This will be followed by creating a data
matrix suitable for quantitative data analysis. Descriptive
statistics (frequencies) will be used. Throughout the anal-
yses, rigour and reliability will be maximised74 75 by following
a systematic and consistent approach and the concepts of
credibility, dependability and transferability will be applied
to achieve trustworthiness.76 In addition, the entire dataset
will be double coded by two researchers within 2–3 weeks
after the initial coding (MW, BS). The researchers are aware
of their effect on the interview process and outcomes based
on the concept of reflexivity.77
DISCUSSION
The pilot study will investigate the feasibility of an individu-
alised, task- oriented, video- based versus a paper- based home-
exercise programme in PaS in the subacute stage with mild
to moderate upper limb paresis. For the study intervention,
the principles of the OPTIMAL theory of motor learning are
applied.
Home environment training is challenging because
sessions often lack structuring, which may negatively impact
on patient engagement.19 It is key for outpatient rehabili-
tation to maintain high levels of patients’ motivation, even
more for the home environment.78 Numerous studies have
demonstrated that familiar environments enhance rehabil-
itation outcomes as they facilitate meaningful task- specific
training, sense of control, confidence and skill transfer
on January 5, 2022 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2021-051504 on 4 January 2022. Downloaded from
7
WannerM, etal. BMJ Open 2022;12:e051504. doi:10.1136/bmjopen-2021-051504
Open access
into daily life.78 79 Thus, outpatient rehabilitation typically is
client- centred and involves content- specific training.78 80 81
During the intervention development phase, we decided
to include the three aspects of the OPTIMAL- theory from
Wulf and Lewthwaite,15 such as enhanced performance
expectancies, autonomy support and an external focus of
attention. Evidence has shown that a focus on the task goal
boosts motor performance and motor learning. In addition,
intermittent supervision, self- monitoring combined with
client- centred goals, progression and feedback are crucial
for encouraging adherence and advancement.82
With respect to the outcome measures, not having chosen
the Fugl- Meyer Assessment (FMA)83 for this study may be
a significant study limitation because the FMA is the most
frequently used and a highly recommended tool in stroke
research and so, it could be valuable to compare the current
patient group to other studies. Therefore, the FMA will be
used as an outcome measure in the planned follow- up study.
The primary aim of this pilot study is to assess the feasibility
of two intervention delivery methods and its acceptability in
patients in the subacute phase after stroke, and to prepare a
full- scale RCT.84
Contributors Authors critically and substantially revised the manuscript and
approved the current version to be submitted for publication. MW and BS devised
and designed the study and drafted the manuscript. GS substantially contributed to
the conception and design of the study. SK, MK and CM provided substantial input
on the study methodology and quantitative analysis. MK is a study manager at his
centre. All authors critically revised and approved the nal manuscript.
Funding This research received no specic grant from any funding agency in the
public, commercial or not- for- prot sectors. An open- access publication fee will be
covered by VASCage, Research Centre on Vascular Ageing and Stroke, Innrain 66a,
Innsbruck, Austria.
Competing interests None declared.
Patient consent for publication Not applicable.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has
not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been
peer- reviewed. Any opinions or recommendations discussed are solely those
of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and
responsibility arising from any reliance placed on the content. Where the content
includes any translated material, BMJ does not warrant the accuracy and reliability
of the translations (including but not limited to local regulations, clinical guidelines,
terminology, drug names and drug dosages), and is not responsible for any error
and/or omissions arising from translation and adaptation or otherwise.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non- commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non- commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
ORCID iD
BarbaraSeebacher http://orcid.org/0000-0001-5699-9077
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Objective: To investigate the effectiveness of self-administered, home-based, upper limb practice in improving upper limb activity after stroke. To compare structured home-based practice vs non-structured home-based practice. Methods: Databases were searched for randomized or quasi-randomized controlled trials using a pre-defined search strategy. Data were extracted from 15 studies involving 788 participants. The quality of included studies was assessed using the PEDro scale. The experimental group received self-administered home-based practice for people with upper limb activity limitations of any level of severity and any time after stroke. The control group received no intervention, or non-structured home-based practice. Only measures of upper limb activity were investigated. Results: Self-administered, home-based, practice did not improve activity compared with no intervention (standardized mean difference; SMD 0.00, 95% confidence interval; 95% CI -0.47 to 0.48). There was no difference between structured and non-structured home-based practice in terms of upper limb activity (SMD -0.05, 95% CI -0.22 to 0.13). Conclusion: Existing self-administered home-based practice is not more effective than no intervention in improving upper limb activity in chronic, severely disabled stroke survivors. Structured home-based practice is no more effective than non-structured home-based practice.
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Background: Telerehabilitation offers an alternate way of delivering rehabilitation services. Information and communication technologies are used to facilitate communication between the healthcare professional and the patient in a remote location. The use of telerehabilitation is becoming more viable as the speed and sophistication of communication technologies improve. However, it is currently unclear how effective this model of delivery is relative to rehabilitation delivered face-to-face or when added to usual care. Objectives: To determine whether the use of telerehabilitation leads to improved ability to perform activities of daily living amongst stroke survivors when compared with (1) in-person rehabilitation (when the clinician and the patient are at the same physical location and rehabilitation is provided face-to-face); or (2) no rehabilitation or usual care. Secondary objectives were to determine whether use of telerehabilitation leads to greater independence in self-care and domestic life and improved mobility, balance, health-related quality of life, depression, upper limb function, cognitive function or functional communication when compared with in-person rehabilitation and no rehabilitation. Additionally, we aimed to report on the presence of adverse events, cost-effectiveness, feasibility and levels of user satisfaction associated with telerehabilitation interventions. Search methods: We searched the Cochrane Stroke Group Trials Register (June 2019), the Cochrane Central Register of Controlled Trials (the Cochrane Library, Issue 6, 2019), MEDLINE (Ovid, 1946 to June 2019), Embase (1974 to June 2019), and eight additional databases. We searched trial registries and reference lists. Selection criteria: Randomised controlled trials (RCTs) of telerehabilitation in stroke. We included studies that compared telerehabilitation with in-person rehabilitation or no rehabilitation. In addition, we synthesised and described the results of RCTs that compared two different methods of delivering telerehabilitation services without an alternative group. We included rehabilitation programmes that used a combination of telerehabilitation and in-person rehabilitation provided that the greater proportion of intervention was provided via telerehabilitation. Data collection and analysis: Two review authors independently identified trials on the basis of prespecified inclusion criteria, extracted data and assessed risk of bias. A third review author moderated any disagreements. The review authors contacted investigators to ask for missing information. We used GRADE to assess the quality of the evidence and interpret findings. Main results: We included 22 trials in the review involving a total of 1937 participants. The studies ranged in size from the inclusion of 10 participants to 536 participants, and reporting quality was often inadequate, particularly in relation to random sequence generation and allocation concealment. Selective outcome reporting and incomplete outcome data were apparent in several studies. Study interventions and comparisons varied, meaning that, in many cases, it was inappropriate to pool studies. Intervention approaches included post-hospital discharge support programs, upper limb training, lower limb and mobility retraining and communication therapy for people with post-stroke language disorders. Studies were either conducted upon discharge from hospital or with people in the subacute or chronic phases following stroke. Primary outcome: we found moderate-quality evidence that there was no difference in activities of daily living between people who received a post-hospital discharge telerehabilitation intervention and those who received usual care (based on 2 studies with 661 participants (standardised mean difference (SMD) -0.00, 95% confidence interval (CI) -0.15 to 0.15)). We found low-quality evidence of no difference in effects on activities of daily living between telerehabilitation and in-person physical therapy programmes (based on 2 studies with 75 participants: SMD 0.03, 95% CI -0.43 to 0.48). Secondary outcomes: we found a low quality of evidence that there was no difference between telerehabilitation and in-person rehabilitation for balance outcomes (based on 3 studies with 106 participants: SMD 0.08, 95%CI -0.30 to 0.46). Pooling of three studies with 569 participants showed moderate-quality evidence that there was no difference between those who received post-discharge support interventions and those who received usual care on health-related quality of life (SMD 0.03, 95% CI -0.14 to 0.20). Similarly, pooling of six studies (with 1145 participants) found moderate-quality evidence that there was no difference in depressive symptoms when comparing post-discharge tele-support programs with usual care (SMD -0.04, 95% CI -0.19 to 0.11). We found no difference between groups for upper limb function (based on 3 studies with 170 participants: mean difference (MD) 1.23, 95% CI -2.17 to 4.64, low-quality evidence) when a computer program was used to remotely retrain upper limb function in comparison to in-person therapy. Evidence was insufficient to draw conclusions on the effects of telerehabilitation on mobility or participant satisfaction with the intervention. No studies evaluated the cost-effectiveness of telerehabilitation; however, five of the studies reported health service utilisation outcomes or costs of the interventions provided within the study. Two studies reported on adverse events, although no serious trial-related adverse events were reported. Authors' conclusions: While there is now an increasing number of RCTs testing the efficacy of telerehabilitation, it is hard to draw conclusions about the effects as interventions and comparators varied greatly across studies. In addition, there were few adequately powered studies and several studies included in this review were at risk of bias. At this point, there is only low or moderate-level evidence testing whether telerehabilitation is a more effective or similarly effective way to provide rehabilitation. Short-term post-hospital discharge telerehabilitation programmes have not been shown to reduce depressive symptoms, improve quality of life, or improve independence in activities of daily living when compared with usual care. Studies comparing telerehabilitation and in-person therapy have also not found significantly different outcomes between groups, suggesting that telerehabilitation is not inferior. Some studies reported that telerehabilitation was less expensive to provide but information was lacking about cost-effectiveness. Only two trials reported on whether or not any adverse events had occurred; these trials found no serious adverse events were related to telerehabilitation. The field is still emerging and more studies are needed to draw more definitive conclusions. In addition, while this review examined the efficacy of telerehabilitation when tested in randomised trials, studies that use mixed methods to evaluate the acceptability and feasibility of telehealth interventions are incredibly valuable in measuring outcomes.
Article
Stroke remains a leading cause of adult disability and the demand for stroke rehabilitation services is growing. Substantial advances are yet to be made in stroke rehabilitation practice to meet this demand and improve patient outcomes relative to current care. Several large intervention trials targeting motor recovery report that participants' motor performance improved, but to a similar extent for both the intervention and control groups in most trials. These neutral results might reflect an absence of additional benefit from the tested interventions or the many challenges of designing and doing large stroke rehabilitation trials. Strategies for improving trial quality include new approaches to the selection of patients, control interventions, and endpoint measures. Although stroke rehabilitation research strives for better trials, interventions, and outcomes, rehabilitation practices continue to help patients regain independence after stroke.
Article
A major goal of the Stroke Recovery and Rehabilitation Roundtable (SRRR) is to accelerate development of effective treatments to enhance stroke recovery beyond that expected to occur spontaneously or with current approaches. In this paper, we describe key issues for the next generation of stroke recovery treatment trials and present the Stroke Recovery and Rehabilitation Roundtable Trials Development Framework (SRRR-TDF). An exemplar (an upper limb recovery trial) is presented to demonstrate the utility of this framework to guide the GO, NO-GO decision-making process in trial development.
Article
Study design: This was a cross-sectional study. Introduction: Home exercise programs (HEPs) are frequently prescribed to maximize a patient's recovery and ensure maintenance of therapeutic gains produced during supervised treatment. Improved understanding of patient preferences and incorporation of simple mobile health technologies may be beneficial strategies for improving patient HEP adherence. Purpose: The purpose of this study was to determine client's preferred mode of home exercise program delivery when offered a choice between a cellular video and paper handout. Methods: A convenience sample was recruited from clients receiving services at an upper extremity rehabilitation facility. Participants were provided a paper handout with written instructions and an audiovisual recording of themselves performing the exercises. A questionnaire was developed to compare clients' preferences and perceptions. Quantitative data regarding patient preference were gathered and analyzed with descriptive statistics. Collected qualitative data were themed to determine the characteristics of home exercise programs (HEPs) perceived by patients. Results: A total of 30 patients participated in the study. Of the 29 responses regarding patient preference of HEP mode, 20 (69%) patients preferred a video, 4 (14%) patients preferred a paper handout, and 5 (17%) patients preferred both paper and video HEP. Patients with preference to a paper HEP reported the handout was helpful to be accessed in a simple manner and could be displayed as a visual reminder to perform the exercises. Those who preferred the cellular video reported increased understanding and confidence with accurate performance of exercises using audiovisual instructions. Discussion: HEP adherence enhancement techniques include improved understanding of patient preferences in order to facilitate customized client-centered treatment. Conclusion: The majority of participants in this study preferred a mobile-based video HEP. Participants perceived the video as visually appealing and a more effective mode of instruction than paper handouts.
Article
Background: Many forms of home-based technology targeting stroke rehabilitation have been devised, and a number of human factors are important to their application, suggesting the need to examine this information in a comprehensive review. Objective: The systematic review aims to synthesize the current knowledge of technologies and human factors in home-based technologies for stroke rehabilitation. Methods: We conducted a systematic literature search in three electronic databases (IEEE, ACM, PubMed), including secondary citations from the literature search. We included articles that used technological means to help stroke patients conduct rehabilitation at home, reported empirical studies that evaluated the technologies with patients in the home environment, and were published in English. Three authors independently conducted the content analysis of searched articles using a list of interactively defined factors. Results: The search yielded 832 potentially relevant articles, leading to 31 articles that were included for in-depth analysis. The types of technology of reviewed articles included games, telerehabilitation, robotic devices, virtual reality devices, sensors, and tablets. We present the merits and limitations of each type of technology. We then derive two main human factors in designing home-based technologies for stroke rehabilitation: designing for engagement (including external and internal motivation) and designing for the home environment (including understanding the social context, practical challenges, and technical proficiency). Conclusion: This systematic review presents an overview of key technologies and human factors for designing home-based technologies for stroke rehabilitation.
Article
Background: Action observation (AO) is a physical rehabilitation approach that facilitates the occurrence of neural plasticity through the activation of the mirror-neural system, promoting motor recovery in people with stroke. Objectives: To assess whether action observation enhances motor function and upper limb motor performance and cortical activation in people with stroke. Search methods: We searched the Cochrane Stroke Group Trials Register (last searched 4 September 2017), the Central Register of Controlled Trials (24 October 2017), MEDLINE (1946 to 24 October 2017), Embase (1974 to 24 October 2017) and five additional databases. We also searched trial registries and reference lists. Selection criteria: Randomized controlled trials (RCTs) of AO, alone or associated with physical practice in adults after stroke. The primary outcome was upper limb motor function. Secondary outcomes included dependence on activities of daily living (ADL), motor performance, cortical activation, quality of life, and adverse effects. Data collection and analysis: Two review authors independently selected trials according to the pre-defined inclusion criteria, extracted data, assessed risk of bias, and applied the GRADE approach to assess the quality of the evidence. The reviews authors contacted trial authors for clarification and missing information. Main results: We included 12 trials involving 478 individuals. A number of trials showed a high risk of bias and others an unclear risk of bias due to poor reporting. The quality of the evidence was 'low' for most of the outcomes and 'moderate' for hand function, according to the GRADE system. In most of the studies, AO was followed by some form of physical activity. Primary outcome: the impact of AO on arm function showed a small significant effect (standardized mean difference (SMD) 0.36, 95% CI 0.13 to 0.60; 8 studies; 314 participants; low-quality evidence); and a large significant effect (mean difference (MD) 2.90, 95% CI 1.13 to 4.66; 3 studies; 132 participants; moderate-quality evidence) on hand function. Secondary outcomes: there was a large significant effect for ADL outcome (SMD 0.86, 95% CI 0.11 to 1.61; 4 studies, 226 participants; low-quality evidence). We were unable to pool other secondary outcomes to extract the evidence. Only two studies reported adverse effects without significant adverse AO events. Authors' conclusions: We found evidence that AO is beneficial in improving upper limb motor function and dependence in activities of daily living (ADL) in people with stroke, when compared with any control group; however, we considered the quality of the evidence to be low. We considered the effect of AO on hand function to be large, but it does not appear to be clinically relevant, although we considered the quality of the evidence as moderate. As such, our confidence in the effect estimate is limited because it will likely change with future research.