Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000274875
Ethics application status
Approved
Date submitted
5/02/2021
Date registered
11/03/2021
Date last updated
11/03/2021
Date data sharing statement initially provided
11/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of a home training program on hand function in people with Parkinson’s disease,
Scientific title
Effect of home-based task-related training on hand function in people with Parkinson’s disease: A pilot randomised controlled feasibility study.
Secondary ID [1] 300502 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 320352 0
Condition category
Condition code
Neurological 318264 318264 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 318391 318391 0 0
Physiotherapy
Physical Medicine / Rehabilitation 318392 318392 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 4-week hand training program based on motor learning principles and delivered by registered physiotherapists and/or occupational therapists trained in the program. In accordance with motor skill learning and task-related training theory, each participant's home program will be individualised and appropriately progressed to maintain sufficient challenge.

Step 1. Introduction to the program.
The participant will be introduced to their individualised training program and the technology in a single one-hour face-to-face session in their home. The therapist will provide participants with home exercise instructions using an online exercise prescription application (Physitrack® https://www.physitrack.com) with uploaded tailored exercises (video and description).
These videos have been developed by the researchers and uploaded to the Physitrack software. The therapist will individualise the home program by choosing videos based on the participant's difficulties and goals. Home programs will include practicing object grasp and manipulation skills, and training of daily activities which require fine manipulation e.g writing and using cutlery.

2. The 4-week intervention.
Intervention group participants will be asked to complete three practice sessions of 30 minutes per week comprised of targeted exercises and activities, and will be encouraged to incorporate learned strategies into the performance of everyday tasks.
Participants will access their exercise program via their own computer or smartphone or a tablet supplied by the researchers. This system will enable participants to record and monitor their exercise completion. Exercise completion will be viewed by the therapists remotely.

In addition, participants will attend a weekly 30-minute telerehabilitation session with the therapist to review and progress the focused activities and provide feedback on activity performance and training.
Home programs will be progressed by changing the attributes of the tasks e.g difficulty can be increased by changing the object (weight, size, texture).

3. Follow-up telerehabilitation coaching session.
After the intensive 4-week program, participants will receive a single, monthly 30-minute telerehabilitation coaching session in weeks 8 and 12 to discuss progress and review transfer of skills in to everyday activities.
Intervention code [1] 319518 0
Rehabilitation
Comparator / control treatment
The control group will not receive an intervention. They will continue with their standard care which can include exercise or physiotherapy programs developed for people with Parkinson's disease..
Control group
Active

Outcomes
Primary outcome [1] 326245 0
Recruitment (composite)
Recruitment rate - determined by number of eligible participants screened vs. number of participants enrolled as assessed by an audit of the study database.
Recruitment data (the number and reasons for exclusion of potential participants and those who decline) will also be recorded.




Timepoint [1] 326245 0
Following completion of study recruitment.
Primary outcome [2] 326333 0
Acceptability of the hand training program and mode of delivery (Intervention group only) - assessed using a study-specific questionnaire.
Timepoint [2] 326333 0
4 weeks post-commencement of the intervention.
Primary outcome [3] 326788 0
Adherence to the hand training program (Intervention group only) -
1. Training diary - participants receiving the intervention will complete a study-specific training diary
2. Physitrack app - data on participant access to the home program.
Timepoint [3] 326788 0
4 weeks post-commencement of the intervention
Secondary outcome [1] 390722 0
Self-reported hand function (Activity questionnaires) - evaluated using two validated measures, the Manual Ability Measure 36 (MAM-36) and Dexterity Questionnaire 24 (DextQ-24).
Timepoint [1] 390722 0
Pre-intervention and 4, 12 & 24 weeks post-commencement of the intervention.
Secondary outcome [2] 391078 0
Hand dexterity - measured with the Purdue Pegboard Test
Timepoint [2] 391078 0
Pre-intervention and 4, 12 & 24 weeks post-commencement of the intervention.
Secondary outcome [3] 392687 0
Retention rate (primary outcome) - determined by the number of participants at baseline vs. number of participants retained in the study at 4, 12 and 24 weeks post-commencement of the intervention. Assessed by an audit of the study database.
Timepoint [3] 392687 0
4, 12 and 24 weeks post-commencement of the intervention

Eligibility
Key inclusion criteria
1. A diagnosis of idiopathic PD confirmed by a neurologist
2. Mild to moderate PD (Hoehn & Yahr Staging Scale score of I-III in the ‘on’ phase of the medication cycle)
3. Limitations in daily hand function
4. A stable levodopa medication regime (no changes to medications in the 4 weeks before commencement of the program
5. Independent community living
6. Adequate computer proficiency to participate in web-based video conferencing
7. Sufficient comprehension of English to complete data collection, understand training instructions and give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A Deep Brain Stimulator device in situ
2. Neurological conditions other than Parkinson's disease
3. Major musculoskeletal comorbidities of the arms and/or hands

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)
Group allocation will be concealed by the use of consecutively numbered opaque envelopes retained by an independent person in a locked location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As the proposed study is a pilot trial designed primarily to investigate the feasibility of the intervention, descriptive statistics will be performed on feasibility measures (recruitment, retention and adherence rates), number of adverse events, and measures of acceptability of the program..
Participant characteristics will be summarised with descriptive statistics.
To explore effectiveness, between group comparisons will be presented as means and confidence intervals, or nonparametric medians and interquartile ranges as appropriate at each time point.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18513 0
North Eastern Rehabilitation Centre - Ivanhoe
Recruitment hospital [2] 18514 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 32852 0
3079 - Ivanhoe
Recruitment postcode(s) [2] 32853 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 304919 0
Charities/Societies/Foundations
Name [1] 304919 0
Parkinson's Victoria
Country [1] 304919 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne,
Grattan Street, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 305267 0
None
Name [1] 305267 0
Address [1] 305267 0
Country [1] 305267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305327 0
University of Melbourne Human Ethics Research Committee
Ethics committee address [1] 305327 0
The University of Melbourne,
Grattan Street, Parkville, Victoria, 3010
Australia
Ethics committee country [1] 305327 0
Australia
Date submitted for ethics approval [1] 305327 0
19/08/2020
Approval date [1] 305327 0
27/08/2020
Ethics approval number [1] 305327 0
1852212.2

Summary
Brief summary
Impaired hand function is a common cause of everyday disability for people with Parkinson’s disease (PD) and can contribute to difficulties in work and leisure activities and daily tasks such as personal care and dressing. Changes in dexterity are also closely associated with reduced quality of life. Despite this, there is little evidence to guide physiotherapy or occupational therapy management of this problem. The primary aim of this pilot randomised controlled trial is to investigate the whether this novel home-based training program, targeted to improving hand function in people with PD, is feasible and acceptable to participants. Participants will be randomly allocated into a training group or a usual care group. The training group will undertake a home-based hand training program and the control group will continue with their usual care. Participants in the training group will be provided with home exercise instructions using an online exercise prescription application with uploaded exercises and will be asked to complete the training for 30 minutes, three times a week for four weeks, The training program will be monitored remotely once a week via telerelerehabilitation. Following the 4-week program there will be two further 30-minute telerehabilitation coaching sessions at 8 and 12 weeks.
Main outcome measures relate to feasibility and include recruitment and retention, participant adherence and satisfaction with the program, and adverse events. Secondary outcomes are associated with the effectiveness of the program and include assessment of fine hand skills and self-reported hand function. Participants will be assessed before randomisation (baseline), post-training (4 weeks), and at 12 weeks and 24 weeks. We hypothesise that the study will show good feasibility with strong retention, adherence and high satisfaction with the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100010 0
Dr Elizabeth Proud
Address 100010 0
Department of Physiotherapy, School of Health Sciences
Level 7, Alan Gilbert Building,
The University of Melbourne,
Grattan Street, Parkville, Victoria, 3010
Country 100010 0
Australia
Phone 100010 0
+61411030318
Fax 100010 0
Email 100010 0
[email protected]
Contact person for public queries
Name 100011 0
Dr Elizabeth Proud
Address 100011 0
Department of Physiotherapy, School of Health Sciences,
Level 7, Alan Gilbert Building,
The University of Melbourne,
Grattan Street, Parkville, Victoria, 3010
Country 100011 0
Australia
Phone 100011 0
+61 3 8344 3920
Fax 100011 0
Email 100011 0
[email protected]
Contact person for scientific queries
Name 100012 0
Dr Elizabeth Proud
Address 100012 0
Department of Physiotherapy, School of Health Sciences,
Level 7, Alan Gilbert Building,
The University of Melbourne,
Grattan Street, Parkville, Victoria, 3010
Country 100012 0
Australia
Phone 100012 0
+61411030318
Fax 100012 0
Email 100012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
On a case by case basis at the discretion of the study team and The University of Melbourne.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.