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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 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
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
Secondary ID [1] 282785 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 289551 0
Condition category
Condition code
Stroke 289876 289876 0 0
Ischaemic
Stroke 289877 289877 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 289881 289881 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287462 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 289937 0
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.
Timepoint [1] 289937 0
Over 4 week intervention period.
Secondary outcome [1] 303608 0
Upper limb function measured using Wolf Motor Function Test
Timepoint [1] 303608 0
Baseline and at end of the intervention period (4 weeks)
Secondary outcome [2] 303609 0
Satisfaction with home exercise program, using written questionnaire designed specifically for the purpose of the study.
Timepoint [2] 303609 0
At the conclusion of the intervention period (4 weeks)
Secondary outcome [3] 303610 0
Service data - time spent with occupational therapist, number of treatment sessions received
Timepoint [3] 303610 0
Recorded during the 4 week intervention period

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
10/02/2014
Date of last participant enrolment
Anticipated
1/07/2014
Actual
5/11/2015
Date of last data collection
Anticipated
Actual
10/12/2015
Sample size
Target
72
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1203 0
Eastern Health
Recruitment postcode(s) [1] 7066 0
3151 - Burwood East
Recruitment postcode(s) [2] 7067 0
3152 - Wantirna

Funding & Sponsors
Funding source category [1] 287557 0
Charities/Societies/Foundations
Name [1] 287557 0
Eastern Health Foundation
Country [1] 287557 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 Arnold Street, Box Hill
VIC 3128
Country
Australia
Secondary sponsor category [1] 286308 0
None
Name [1] 286308 0
Address [1] 286308 0
Country [1] 286308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289534 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 289534 0
Ethics committee country [1] 289534 0
Australia
Date submitted for ethics approval [1] 289534 0
Approval date [1] 289534 0
25/06/2013
Ethics approval number [1] 289534 0
LR98-1213

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41234 0
Ms Kellie Emmerson
Address 41234 0
Community Rehabilitation Program, Eastern Health
Locked Bag 1, Forest Hill VIC 3131
Country 41234 0
Australia
Phone 41234 0
61 3 9881 1842
Fax 41234 0
Email 41234 0
[email protected]
Contact person for public queries
Name 41235 0
Katherine Harding
Address 41235 0
Allied Health Resaerch Office,
Level 2, 5 Arnold Street
Box Hill VIC 3128
Country 41235 0
Australia
Phone 41235 0
61 3 9091 8880
Fax 41235 0
Email 41235 0
[email protected]
Contact person for scientific queries
Name 41236 0
Katherine Harding
Address 41236 0
Allied Health Resaerch Office,
Level 2, 5 Arnold Street
Box Hill VIC 3128
Country 41236 0
Australia
Phone 41236 0
61 3 9091 8880
Fax 41236 0
Email 41236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not included in the ethical approval for the project.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4166Ethical approval  [email protected]
4167Study protocol  [email protected]
4168Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHome exercise programmes supported by video and automated reminders compared with standard paper-based home exercise programmes in patients with stroke: a randomized controlled trial.2017https://dx.doi.org/10.1177/0269215516680856
N.B. These documents automatically identified may not have been verified by the study sponsor.