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Trial registered on ANZCTR
Registration number
ACTRN12613000786796
Ethics application status
Approved
Date submitted
4/07/2013
Date registered
15/07/2013
Date last updated
21/08/2019
Date data sharing statement initially provided
21/08/2019
Date results information initially provided
21/08/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A comparison of Home Exercise Programs supported by video and automated reminders with standard paper-based Home Exercise Programs on adherence and functional outcomes in stroke patients
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Scientific title
A comparison of Home Exercise Programs supported by video and automated reminders with standard paper-based Home Exercise Programs on adherence and functional outcomes in stroke patients
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Secondary ID [1]
282785
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
289551
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Condition category
Condition code
Stroke
289876
289876
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0
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Ischaemic
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Stroke
289877
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0
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Haemorrhagic
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Physical Medicine / Rehabilitation
289881
289881
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0
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Occupational therapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Home exercise programs of 4 weeks duration presented using video recorded and played back on touch screen tablets (iPads) with electronic reminders.
The content of both the home exercise programs (for both the intervention and control groups) will be based on the recommendations from the Stroke Foundation Clinical Guidelines (2010), including techniques such as:
* Constraint-induced movement therapy in selected people
* Repetitive task-specific training
* Mechanical assisted training
* Mirror therapy
* Bilateral training
Home programs are typically recommended to be completed 2 times per day, but specific dosage is at the discretion of the managing therapist. Reminders will be set to sound once at the recommended time of each prescribed session.
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Intervention code [1]
287462
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Rehabilitation
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Comparator / control treatment
Traditional paper-based home exercise instructions, using brief written descriptions and diagrams. Content of the exercise sessions will be the same as the intervention group; only the mode of delivery will differ between groups.
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Control group
Active
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Outcomes
Primary outcome [1]
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Exercise adherence - Clients from both the experimental and control groups will be asked to keep a log of the minutes spent per day on their home exercises and details of exercises completed. These log books will be issued by and returned to the blinded assessor in an effort to minimise social desirability bias that may occur if the logbooks are managed by a treating therapist.
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Assessment method [1]
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Timepoint [1]
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Over 4 week intervention period.
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Secondary outcome [1]
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Upper limb function measured using Wolf Motor Function Test
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Assessment method [1]
303608
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Timepoint [1]
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Baseline and at end of the intervention period (4 weeks)
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Secondary outcome [2]
303609
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Satisfaction with home exercise program, using written questionnaire designed specifically for the purpose of the study.
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Assessment method [2]
303609
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Timepoint [2]
303609
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At the conclusion of the intervention period (4 weeks)
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Secondary outcome [3]
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Service data - time spent with occupational therapist, number of treatment sessions received
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Assessment method [3]
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Timepoint [3]
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Recorded during the 4 week intervention period
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Eligibility
Key inclusion criteria
Clients referred to the Eastern Health Community Rehabilitation Program (Peter James Centre and Wantirna Health sites) with a diagnosis of stroke, resulting in any degree of impairment to upper limb function.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Visual or cognitive deficits that would prevent use of the technology, if no carer or family member is available to provide daily assistance.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Upon admission to the Community Rehabilitation Program and once upper limb impairment have been noted by the treating clinician, written informed consent will be sought from patients who meet inclusion criteria to participate in the study. Consent will be sought from carers of potential participants who have cognitive deficits, if the carer is intending to provide assistance with the patient’s home exercise program and is willing to participate in the study.
Clients will be randomly assigned to the control and experimental groups using a block randomisation sequence with allocation concealed using sealed envelopes. The randomisation process will be managed from an independent off-site office to ensure that the randomisation is independent from the recruitment process.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation sequence will be computer-generated using randomisation.com.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A sample size of 36 participants for each group will be recruited. This sample size will allow detection of a moderate to large effect size on the primary clinical outcome, the Wolf Motor Function Test (above the minimum clinically significant difference of a 20% change in score) with alpha set at 0.05 and power of 0.8.
Outcome measures for upper limb function will be compared at discharge using Analysis of Co-variance (ANCOVA) with admission scores as a covariate.
Average daily and weekly time spent on home exercise program will be compared using independent samples t-tests or the Mann Whitney U-Test for non-parametric data.
Data from the satisfaction questionnaire will be analysed using a descriptive synthesis.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/08/2013
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Actual
10/02/2014
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Date of last participant enrolment
Anticipated
1/07/2014
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Actual
5/11/2015
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Date of last data collection
Anticipated
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Actual
10/12/2015
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Sample size
Target
72
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
1203
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Eastern Health
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Recruitment postcode(s) [1]
7066
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3151 - Burwood East
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Recruitment postcode(s) [2]
7067
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3152 - Wantirna
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Eastern Health Foundation
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Address [1]
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5 Arnold Street, Box Hill 3128
VIC, AUSTRALIA
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Eastern Health
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Address
5 Arnold Street, Box Hill
VIC 3128
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
286308
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Address [1]
286308
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Country [1]
286308
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289534
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Eastern Health Research and Ethics Committee
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Ethics committee address [1]
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Level 3, 5 Arnold Street
Box Hill, VIC 3128
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Ethics committee country [1]
289534
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Australia
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Date submitted for ethics approval [1]
289534
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Approval date [1]
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25/06/2013
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Ethics approval number [1]
289534
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LR98-1213
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Summary
Brief summary
Allied Health professionals working in rehabilitation frequently prescribe home exercise programs for clients to complete independently between therapy sessions. Written notes or pictures are commonly provided as reminders to clients when prescribing home exercises. These paper based programs are sometimes difficult to follow, and growing collections of paper over the course of a rehabilitation program can become confusing and overwhelming for patients.
Many new forms of technology are becoming increasingly accessible to people within the community. Smart technology applications for smart phones and touch-screen tablets are being adopted in rehabilitation settings for such things as: cognitive rehabilitation; cognitive compensatory strategies (such as memory aids); assisting with communication (using picture boards, for example); and improving fine motor skills. However, these devices also provide easy access to other tools such as reminder functions and video recording that could be used to enhance rehabilitation programs.
This project aims to explore the feasibility and effectiveness of using the video and reminder functions on touch-screen tablets as a support to prescribed home exercise programs for patients with upper limb deficits following stroke. Specifically, we aim to determine whether patients receiving rehabilitation after stroke using this technology demonstrate greater adherence to prescribed home exercise programs and better functional outcomes when compared to traditional paper based exercise prescription.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Kellie Emmerson
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Address
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Community Rehabilitation Program, Eastern Health
Locked Bag 1, Forest Hill VIC 3131
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Country
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Australia
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Phone
41234
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61 3 9881 1842
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Fax
41234
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Email
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[email protected]
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Contact person for public queries
Name
41235
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Dr Katherine Harding
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Address
41235
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Allied Health Resaerch Office,
Level 2, 5 Arnold Street
Box Hill VIC 3128
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Country
41235
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Australia
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Phone
41235
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61 3 9091 8880
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Fax
41235
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Email
41235
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[email protected]
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Contact person for scientific queries
Name
41236
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Dr Katherine Harding
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Address
41236
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Allied Health Resaerch Office,
Level 2, 5 Arnold Street
Box Hill VIC 3128
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Country
41236
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Australia
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Phone
41236
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61 3 9091 8880
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Fax
41236
0
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Email
41236
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This was not included in the ethical approval for the project.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4166
Ethical approval
[email protected]
4167
Study protocol
[email protected]
4168
Informed consent form
[email protected]
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Emmerson KB, Harding KE, Taylor NF. Home exercise ...
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364544-(Uploaded-19-08-2019-11-45-55)-Journal results publication.docx
Basic results
No
364544-(Uploaded-14-08-2019-12-14-21)-Basic results summary.pdf
Plain language summary
No
This study aimed to find out whether stroke patien...
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Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Home exercise programmes supported by video and automated reminders compared with standard paper-based home exercise programmes in patients with stroke: a randomized controlled trial.
2017
https://dx.doi.org/10.1177/0269215516680856
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF