ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

Ischaemic

Stroke

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]

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]

Walking speed in the five meter walk test (5mWT)

Timepoint [1]

4-weeks after baseline assessment

Secondary outcome [1]

Walking capacity during the six minute walk test (6MWT)

Timepoint [1]

4-weeks and 6-months after baseline assessment

Secondary outcome [2]

Walking speed (5mWT)

Timepoint [2]

6-months after baseline assessment

Secondary outcome [3]

Health status (EQ visual analogue scale)

Timepoint [3]

4-weeks and 6-months after baseline assessment

Secondary outcome [4]

Community participation ( 2 questions r.e. number and satisfaction with community outings)

Timepoint [4]

4-weeks and 6-months after baseline assessment

Secondary outcome [5]

Walking self-efficacy scale

Timepoint [5]

4-weeks and 6-months after baseline assessment

Secondary outcome [6]

Physical activity (activPAL monitor)

Timepoint [6]

4-weeks and 6-months after baseline assessment

Secondary outcome [7]

Adherence data including intervention sessions attended, reasons for non-attendance, time in intervention and exercise repetitions completed from intervention study records.

Timepoint [7]

Throughout the intervention (weeks 1-3)

Secondary outcome [8]

Acceptability of the program through one on one interviews

Timepoint [8]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Stroke Foundation

Address [1]

Level 7, 461 Bourke Street
Melbourne Vic 3000

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Rd
Macquarie Park NSW 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee Medical Sciences

Ethics committee address [1]

Balaclava Rd
Macquarie Park NSW 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/03/2023

Approval date [1]

12/05/2023

Ethics approval number [1]

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

Dr Kate Scrivener

Address

Department of Health Sciences
75 Talavera Rd
Macquarie University, NSW 2109

Country

Australia

Phone

+61 2 9850 6625

Fax

kate.scrivener@mq.edu.au

Contact person for public queries

Name

Kate Scrivener

Address

Department of Health Sciences
75 Talavera Rd
Macquarie University, NSW 2109

Country

Australia

Phone

+61 2 9850 6625

Fax

kate.scrivener@mq.edu.au

Contact person for scientific queries

Name

Kate Scrivener

Address

Department of Health Sciences
75 Talavera Rd
Macquarie University, NSW 2109

Country

Australia

Phone

+61 2 9850 6625

Fax

kate.scrivener@mq.edu.au

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 kate.scrivener@mq.edu.au for access information.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18598	Study protocol				Citation will be provided post publication

Results publications and other study-related documents

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