Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000355471
Ethics application status
Approved
Date submitted
4/04/2025
Date registered
24/04/2025
Date last updated
24/04/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive arm rehabilitation for people with stroke
Scientific title
The effect of an intensive stroke upper limb training program on impairment in rural Australia: a hub-spoke randomised wait-list controlled trial
Secondary ID [1] 314140 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 336955 0
Condition category
Condition code
Stroke 333427 333427 0 0
Haemorrhagic
Stroke 333426 333426 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete upper-limb sensorimotor rehabilitation addressing identified impairments to improve upper-limb function. Individualised programs will be based on initial assessments (to identify impairments and functional limitations) and rehabilitation goals. All participants will complete a 5-week program delivering 3h per day, 5 days per week (total 75h). Delivery is based on a hub-spoke model. The central hub (Adelaide) will be responsible or training and upskilling clinicians in delivery of the intervention. Programs will be delivered at the central hub and several satellite sites (Whyalla, Mt Gambier, Elizabeth). At each delivery site, therapy will comprise: 1) An upper-limb group exercise class (ratio 4:1), 2) Rehabilitation technologies (for example, robotics, virtual reality, EEG EMG biofeedback, non-immersive gaming, functional electrical stimulation and interactive multisensory gaming technologies, 3) task-specific training (1:1), 4) A home exercise program based on the Graded Repetitive Arm Supplementary Program (GRASP) or pre-recorded videos such as Different Strokes UK YouTube (informed by impairment level and patient preference). Adherence to the program will be recorded with treatment diaries. Each 5 week program will have a maximum of 4 patients.
Intervention code [1] 330727 0
Rehabilitation
Comparator / control treatment
wait-list control.
Equivalent duration (5 weeks).
Patients will continue usual care which will be documented. Usual care is defined as the participants completing their usual activities as part of their standard care program.
Control group
Active

Outcomes
Primary outcome [1] 340996 0
Upper limb impairment
Timepoint [1] 340996 0
Baseline (prior to starting the intervention program) Immediately post completion of the intervention (primary endpoint) 3 months post completion of the intervention
Secondary outcome [1] 445732 0
Upper limb function
Timepoint [1] 445732 0
Baseline (prior to starting the intervention program) Immediately post completion of the intervention 3 months post completion of the intervention
Secondary outcome [2] 445734 0
Quality of life
Timepoint [2] 445734 0
Baseline (prior to starting the intervention program) Immediately post completion of the intervention 3 months post completion of the intervention
Secondary outcome [3] 445733 0
self-efficacy
Timepoint [3] 445733 0
Baseline (prior to starting the intervention program) Immediately post completion of the intervention 3 months post completion of the intervention

Eligibility
Key inclusion criteria
Prior history of stroke
Community dwelling
Aged 18 years or older
Documented level of upper limb impairment (determined as <61/66 on the Fugl-Meyer)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unstable
Inability to provide informed consent
Additional neurological or physical impairments affecting upper limb function

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)
central randomisation computer randomisation.
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Wait-list randomised controlled trial
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA

Funding & Sponsors
Funding source category [1] 318649 0
Charities/Societies/Foundations
Name [1] 318649 0
Hospital Research Foundation
Country [1] 318649 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 321069 0
None
Name [1] 321069 0
Address [1] 321069 0
Country [1] 321069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317260 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 317260 0
Ethics committee country [1] 317260 0
Australia
Date submitted for ethics approval [1] 317260 0
20/03/2025
Approval date [1] 317260 0
27/03/2025
Ethics approval number [1] 317260 0

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

Contacts
Principal investigator
Name 140494 0
Dr Brenton Hordacre
Address 140494 0
University of South Australia, City East Campus, Corner of North Terrace and Frome Rd, Adelaide, South Australia 5001
Country 140494 0
Australia
Phone 140494 0
+61 08 83021286
Fax 140494 0
Email 140494 0
[email protected]
Contact person for public queries
Name 140495 0
Brenton Hordacre
Address 140495 0
University of South Australia, City East Campus, Corner of North Terrace and Frome Rd, Adelaide, South Australia 5001
Country 140495 0
Australia
Phone 140495 0
+61 08 83021286
Fax 140495 0
Email 140495 0
[email protected]
Contact person for scientific queries
Name 140496 0
Brenton Hordacre
Address 140496 0
University of South Australia, City East Campus, Corner of North Terrace and Frome Rd, Adelaide, South Australia 5001
Country 140496 0
Australia
Phone 140496 0
+61 08 83021286
Fax 140496 0
Email 140496 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.