None listed
Conditions
Brief summary
An early start to upper limb rehabilitation after stroke is critical to optimize functional outcomes. Our project aims to test this theory by delivery high dose upper limb rehabilitation, consistent with 2-hours of therapy in the first 6-months post-stroke. We will randomise participants to one of two groups based on our current understanding of the timing and biology of recovery: Early will start <10 days post-stroke and continue up to 3-months post-stroke, and Late will start 3-months post-stroke and continue to 6-months post-stroke. This study will identify if high dose upper limb rehabilitation in the first 6-months shows promise, is feasible and safe. Our study adopts an innovative approach to how we undertake rehabilitation trials in stroke.
Interventions
High dose upper limb rehabilitation will be delivered by a registered therapists (physiotherapist, occupational therapist, rehabilitation assistants). The dose of rehabilitation is 2-hours per weekday, for 50-weekdays over 10-weeks. Participants will be randomized to complete trhis dose early (between <=10-days to -3 months) or late (between 3- to 6-months). High dose upper limb motor rehabilitation will be distributed throughout the day (e.g., 15-20 minutes per session) to optimise the number o
High dose upper limb rehabilitation will be delivered by a registered therapists (physiotherapist, occupational therapist, rehabilitation assistants). The dose of rehabilitation is 2-hours per weekday, for 50-weekdays over 10-weeks. Participants will be randomized to complete trhis dose early (between <=10-days to -3 months) or late (between 3- to 6-months). High dose upper limb motor rehabilitation will be distributed throughout the day (e.g., 15-20 minutes per session) to optimise the number of repetitions that can be completed, as well as support competing therapy demands. Our protocol focuses on impairment (e.g., strength, flexibility) and task-specific (e.g., reach, grasp) motor rehabilitation training. We will use assistive technologies considered standard of care in current stroke guidelines in Australia e.g., electrical stimulation as deemed suitable by the therapy team. Therapists will deliver rehabilitation according to a semi-supervised protocol, where a mix of fully supervised, semi-supervised and independent self-practice will be completed as able on an individual basis. All rehabilitation will be recorded on paper logs by therapist/s or the patient (and family, significant others). When participants are not involved in the intervention rehabilitation protocol, they will receive standard rehabilitation that approximates 15 to 30 minutes/day from physiotherapists/occupational therapists at their local site. The dose of standard rehabilitation will be consistent across the early and late groups. If standard rehabilitation is not provided to a participant, one of our therapists will provide a self-practice program for 15 to 30 minutes/day to ensure that all participants receive the same therapy. All rehabilitation will be recorded on paper logs by the routine therapist/s or the patient (and family, significant others).
Sponsors
Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients admitted with stroke at each of the study sites during the recruitment period will be screened for eligibility against the following inclusion criteria: - Hospital diagnosis of stroke confirmed by site neurologist using clinical scanning (CT/MRI), - Aged >17 years, - Upper limb impairment consistent with shoulder abduction and finger extension (SAFE) score >0 but <5 within 3-days of stroke (equivalent to a flicker or more, but less than antigravity movement), - Able to undergo a motor evoked potential (MEP) evaluation, and - Able to provide written informed consent; note, family consent will be sought from individuals with insufficient comprehension to consent, defined by a score >5 on Short Portable Mental State test.
Exclusion criteria
Patients will be excluded if they have: - Had a previous stroke(s) in the motor area with residual deficits; - Palliation or comorbid medical illness which in the opinion of the treating neurologist, it is deemed unlikely the patient will live 6-months or be able to actively participate in rehabilitation; - Concomitant condition that would interfere with assessment.
Outcome results
None listed