ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Physical Medicine / Rehabilitation

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]

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]

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]

Over 4 week intervention period.

Secondary outcome [1]

Upper limb function measured using Wolf Motor Function Test

Timepoint [1]

Baseline and at end of the intervention period (4 weeks)

Secondary outcome [2]

Satisfaction with home exercise program, using written questionnaire designed specifically for the purpose of the study.

Timepoint [2]

At the conclusion of the intervention period (4 weeks)

Secondary outcome [3]

Service data - time spent with occupational therapist, number of treatment sessions received

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Eastern Health

Recruitment postcode(s) [1]

3151 - Burwood East

Recruitment postcode(s) [2]

3152 - Wantirna

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Eastern Health Foundation

Address [1]

5 Arnold Street, Box Hill 3128
VIC, AUSTRALIA

Country [1]

Australia

Primary sponsor type

Hospital

Name

Eastern Health

Address

5 Arnold Street, Box Hill
VIC 3128

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Research and Ethics Committee

Ethics committee address [1]

Level 3, 5 Arnold Street
Box Hill, VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/06/2013

Ethics approval number [1]

LR98-1213

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Kellie Emmerson

Address

Community Rehabilitation Program, Eastern Health
Locked Bag 1, Forest Hill VIC 3131

Country

Australia

Phone

61 3 9881 1842

Fax

kellie.emmerson@easternhealth.org.au

Contact person for public queries

Name

Katherine Harding

Address

Allied Health Resaerch Office,
Level 2, 5 Arnold Street
Box Hill VIC 3128

Country

Australia

Phone

61 3 9091 8880

Fax

katherine.harding@easternhealth.org.au

Contact person for scientific queries

Name

Katherine Harding

Address

Allied Health Resaerch Office,
Level 2, 5 Arnold Street
Box Hill VIC 3128

Country

Australia

Phone

61 3 9091 8880

Fax

katherine.harding@easternhealth.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
4166	Ethical approval	katherine.harding@easternhealth.org.au
4167	Study protocol	katherine.harding@easternhealth.org.au
4168	Informed consent form	katherine.harding@easternhealth.org.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

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.

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Documents added manually

Documents added automatically