Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000452695
Ethics application status
Approved
Date submitted
31/03/2023
Date registered
2/05/2023
Date last updated
21/04/2024
Date data sharing statement initially provided
2/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
An intensive rehabilitation clinic for upper limb recovery after stroke.
Scientific title
The effect of an intensive, high dose, stroke recovery clinic on upper limb outcomes.
Secondary ID [1] 309364 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 329580 0
Condition category
Condition code
Stroke 326500 326500 0 0
Haemorrhagic
Stroke 326501 326501 0 0
Ischaemic
Physical Medicine / Rehabilitation 326628 326628 0 0
Physiotherapy

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 and rehabilitation goals. All participants will complete a 5-week program delivering 90 hours of therapy (18h per week) comprising: 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). The 18h per week will be achieved by 13h delivered in person (based on tasks above) and 5h of home exercises (1h per weekday, recorded in an activity log). Adherence to both the in person and home program will be recorded. Each 5 week program will have a maximum of 4 patients.

All therapy sessions will be delivered by a Physiotherapist and supported by Physiotherapy and Occupational Therapy students. There will be a minimum of 5 week washout between arms of the trial.
Intervention code [1] 325797 0
Rehabilitation
Comparator / control treatment
Usual care for 5 weeks. This is defined as the participants completing their usual activities as part of their standard care program.
Control group
Active

Outcomes
Primary outcome [1] 334350 0
Feasibility of delivering an intensive rehabilitation program. This will be assessed against the following criteria. If all 4 criteria are met, this program will be considered feasible.
1) greater than 50% of eligible participants who express interest in this project go on to consent to participate (determined from recruitment and consent rates in recruitment logs)
2) greater than 80% of participants achieve 18h of therapy a week (determined from exercise logs)
3) greater than 80% of participants complete 5 weeks of the program (determined from attendance logs) and
4) greater than 80% of participants report the program was useful, helpful and acceptable (Likert scales at least =4/5, determined at end of intervention).
Timepoint [1] 334350 0
End of intervention
Secondary outcome [1] 420338 0
Safety
Treatment-emergent adverse events will be defined as any event not present prior to initiation of the treatment, or any event already present that worsens in either intensity or frequency following initiation of treatment.
Determined by participant report at end of intervention and observations by clinicians.
Timepoint [1] 420338 0
End of intervention
Secondary outcome [2] 420339 0
Upper limb motor impairment (Fugl-Meyer)
Timepoint [2] 420339 0
Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).
Secondary outcome [3] 420340 0
Upper Limb Activity (Action Research Arm Test)
Timepoint [3] 420340 0
Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).
Secondary outcome [4] 420341 0
Stroke-Specific Quality of Life Scale
Timepoint [4] 420341 0
Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).
Secondary outcome [5] 420342 0
Stroke Self-Efficacy Questionnaire
Timepoint [5] 420342 0
Pre intervention (within 1 day of beginning intervention), Post intervention (within 3 days of completing intervention), Pre Control (within 1 day of beginning the control period), Post control (within 1 day of completing the control period).

Eligibility
Key inclusion criteria
People with chronic stroke (greater than 3 months post ictus) will be recruited. Inclusion criteria: Aged at least 18 years, discharged from rehabilitation, any upper-limb sensorimotor impairment (determined by Fugl-Meyer Upper Limb assessment, scoring less than or equal to 62/66).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Painful shoulder limiting ability to undertake rehabilitation, unstable medical conditions, inability to provide informed consent (determined by cognitive screening with MoCA (score at least 26). Those meeting an exclusion criterion may subsequently receive relevant medical input and be re-assessed for potential inclusion at a later time. For example, a patient may not meet eligibility for this study due to shoulder pain, but choose to seek relevant medical input and be re-evaluated for eligibility.

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 by computer
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot study to determine feasibility, safety and preliminary efficacy. We are aiming for 40 participants.
Feasibility will be evaluated against pre-defined criteria and thresholds. Safety will be descriptively reported. Preliminary efficacy will be analysed with a linear mixed model with factor for Time (pre-treatment, post-treatment, pre-control, post-control). Clinical significance of upper-limb gains will be descriptively reported. Regression analysis will determine whether any baseline demographics or characteristics significantly predicts stronger clinical gains (determined as difference from pre-treatment to post-treatment).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/08/2022
Date of last participant enrolment
Anticipated
6/11/2023
Actual
6/11/2023
Date of last data collection
Anticipated
16/02/2024
Actual
16/02/2024
Sample size
Target
40
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24451 0
UniSA Health and Medical Clinic (City West) - Adelaide
Recruitment postcode(s) [1] 40033 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313562 0
Charities/Societies/Foundations
Name [1] 313562 0
Hospital research Foundation
Country [1] 313562 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North Terrace, Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 315342 0
None
Name [1] 315342 0
Address [1] 315342 0
Country [1] 315342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312741 0
University of South Australia’s Human Research Ethics Committee
Ethics committee address [1] 312741 0
Ethics committee country [1] 312741 0
Australia
Date submitted for ethics approval [1] 312741 0
Approval date [1] 312741 0
28/04/2022
Ethics approval number [1] 312741 0

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

Contacts
Principal investigator
Name 125742 0
Dr Brenton Hordacre
Address 125742 0
University of South Australia, 108 North Terrace, Adelaide, South Australia 5001
Country 125742 0
Australia
Phone 125742 0
+61 8 83021286
Fax 125742 0
Email 125742 0
[email protected]
Contact person for public queries
Name 125743 0
Brenton Hordacre
Address 125743 0
University of South Australia, 108 North Terrace, Adelaide, South Australia 5001
Country 125743 0
Australia
Phone 125743 0
+61 8 83021286
Fax 125743 0
Email 125743 0
[email protected]
Contact person for scientific queries
Name 125744 0
Brenton Hordacre
Address 125744 0
University of South Australia, 108 North Terrace, Adelaide, South Australia 5001
Country 125744 0
Australia
Phone 125744 0
+61 8 83021286
Fax 125744 0
Email 125744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.