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Trial registered on ANZCTR


Registration number
ACTRN12623000316606
Ethics application status
Approved
Date submitted
15/03/2023
Date registered
23/03/2023
Date last updated
25/04/2024
Date data sharing statement initially provided
23/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A mobility booster program (HiWalk) in long-term community stroke rehabilitation
Scientific title
Preliminary investigation of the effect of a mobility booster program (HiWalk) on walking speed in long-term community stroke rehabilitation
Secondary ID [1] 309215 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 329359 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326302 326302 0 0
Physiotherapy
Stroke 326347 326347 0 0
Ischaemic
Stroke 326348 326348 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive the HiWalk program for 3 weeks (up to 3 hours a day, five days a week, totaling 45 hours). The HiWalk program consists of an individually tailored motor training program (strength, balance and task training) and specific mobility practice. Some more specific examples include, within strength training participants will complete strengthening exercises of the lower limbs. For mobility practice walking overground or on a treadmill will be practiced, including negotiating obstacles.

Embedded throughout the program is a self-management approach. Participants are guided through the Taking Charge program and set individualised mobility goals. Taking charge is a workbook that asks the individual to reflect on their strengths and challenges and identify the next steps in their recovery journey.

A standardised program assessment identifies the individual program for each participant. The exercise component is delivered as a small group (4-5 participants, 1 facilitator). Each participant's program is reviewed weekly to ensure it remains suitable and is progressed in difficulty as appropriate. If outside of the HiWalk weeks participants usually access therapy they will continue to participate in their usual therapy program which may or may not include physiotherapy.

The HiWalk program is led by a physiotherapist and sessions are facilitated by a physiotherapist, exercise physiologist or allied health assistant/student.

Sessions are completed face-to-face in a community rehabilitation gym. Most sessions are completed as a small group (4-5 people). The program assessment and weekly review are completed one-to-one between each participant and a program therapist.

Each activity within the program has individualised plans developed with the therapist and the participant. Each activity has pre-planned levels of difficulty and modifications that may be enacted in order to individualise the activity to the participants ability.

Adherence to the intervention will be recorded as session attendance (proportion of program sessions attended) and session participation (time attended and exercise repetitions completed).
Intervention code [1] 325661 0
Rehabilitation
Comparator / control treatment
Usual care - this may include no ongoing physiotherapy or allied health intervention. However, if the participant usually accesses allied health support (including physiotherapy) they will continue this. We will describe allied health service usage for both groups.
Control group
Active

Outcomes
Primary outcome [1] 334166 0
Walking speed in the five meter walk test (5mWT)
Timepoint [1] 334166 0
4-weeks after baseline assessment
Secondary outcome [1] 419620 0
Walking capacity during the six minute walk test (6MWT)
Timepoint [1] 419620 0
4-weeks and 6-months after baseline assessment
Secondary outcome [2] 419621 0
Walking speed (5mWT)
Timepoint [2] 419621 0
6-months after baseline assessment
Secondary outcome [3] 419622 0
Health status (EQ visual analogue scale)
Timepoint [3] 419622 0
4-weeks and 6-months after baseline assessment
Secondary outcome [4] 419623 0
Community participation ( 2 questions r.e. number and satisfaction with community outings)
Timepoint [4] 419623 0
4-weeks and 6-months after baseline assessment
Secondary outcome [5] 419624 0
Walking self-efficacy scale
Timepoint [5] 419624 0
4-weeks and 6-months after baseline assessment
Secondary outcome [6] 419625 0
Physical activity (activPAL monitor)
Timepoint [6] 419625 0
4-weeks and 6-months after baseline assessment
Secondary outcome [7] 419823 0
Adherence data including intervention sessions attended, reasons for non-attendance, time in intervention and exercise repetitions completed from intervention study records.
Timepoint [7] 419823 0
Throughout the intervention (weeks 1-3)
Secondary outcome [8] 419824 0
Acceptability of the program through one on one interviews
Timepoint [8] 419824 0
Post-completion of the intervention (week 4-10)

Eligibility
Key inclusion criteria
1. An adult with a diagnosis of stroke > 6 months and < 8 years prior to study commencement
2. Able to walk without assistance of a person or aid over 10 m at a speed of 0.4-1.0 m/s
3. Willing to participate in the high dose therapy program (five days a week) at a local trial site
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to follow two step instructions

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)
Computer-generated, independent and concealed randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be ranked in descending order according to comfortable walking speed over 5m and then organised into matched pairs based on their walking speed. Computer-generated, independent and concealed randomization will be used to assign each participant within the pair to either the intervention or control group (usual care).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample size of 25 per group was chosen as a robust number for a pilot trial, in order to test the program against a control group to inform the power analysis for a future fully-powered trial.

De-identified data analysis will be conducted using R statistical software by a statistician blinded to group allocation. Adherence data will be calculated from each week of the intervention and will be reported as descriptive statistics for the frequency of sessions attended and the number of repetitions of exercise per hour of program attendance. Reasons for non-attendance will be summarised. Acceptability will be determined via the interviews.

For participants, demographic data will be reported via descriptive statistics. Paired t-tests will be used to analyse between groups for the primary outcome at 4-weeks (program completion). Differences will be reported as a mean and 95% confidence interval. Between group differences for the secondary outcomes will also be reported at 4-weeks (program completion) and 6-months. Trends in outcomes (monthly phone call measuring self-reported walking performance and outings) will also be described.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/06/2023
Actual
28/06/2023
Date of last participant enrolment
Anticipated
Actual
10/01/2024
Date of last data collection
Anticipated
10/07/2024
Actual
Sample size
Target
50
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 313403 0
Charities/Societies/Foundations
Name [1] 313403 0
Stroke Foundation
Country [1] 313403 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 315170 0
None
Name [1] 315170 0
Address [1] 315170 0
Country [1] 315170 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312621 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 312621 0
Balaclava Rd
Macquarie Park NSW 2109
Ethics committee country [1] 312621 0
Australia
Date submitted for ethics approval [1] 312621 0
15/03/2023
Approval date [1] 312621 0
12/05/2023
Ethics approval number [1] 312621 0

Summary
Brief summary
This project will investigate a new, short-term mobility program known as the HiWalk program. HiWalk is a physiotherapy program provided at a time of need - meaning if the stroke survivor is experiencing challenges with their mobility or has a new mobility goal (even years after stroke), then this three-week program may assist their walking ability. Our preliminary research has demonstrated that HiWalk could be successfully implemented in the community after stroke and that the HiWalk program was enjoyed by people after stroke. The next, phase of research for the HiWalk program is a pilot trial of HiWalk allowing us to test the program in a clinical trial setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125314 0
Dr Kate Scrivener
Address 125314 0
Department of Health Sciences
75 Talavera Rd
Macquarie University, NSW 2109
Country 125314 0
Australia
Phone 125314 0
+61 2 9850 6625
Fax 125314 0
Email 125314 0
[email protected]
Contact person for public queries
Name 125315 0
Kate Scrivener
Address 125315 0
Department of Health Sciences
75 Talavera Rd
Macquarie University, NSW 2109
Country 125315 0
Australia
Phone 125315 0
+61 2 9850 6625
Fax 125315 0
Email 125315 0
[email protected]
Contact person for scientific queries
Name 125316 0
Kate Scrivener
Address 125316 0
Department of Health Sciences
75 Talavera Rd
Macquarie University, NSW 2109
Country 125316 0
Australia
Phone 125316 0
+61 2 9850 6625
Fax 125316 0
Email 125316 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?
All of the participant clinical outcome data will be anonymised and made available in a data repository.
When will data be available (start and end dates)?
Post completion of the study and finalisation/publication of the results. No end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Macquarie University Data Repository. Contact [email protected] for access information.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18598Study protocol    Citation will be provided post publication



Results publications and other study-related documents

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