None listed
Conditions
Brief summary
DOSE-UP will bring us closer to understanding what the optimal dose of upper limb therapy to delivery to people after stroke. Our project will identify the maximum tolerated dose regimen (MTDR) of upper limb therapy at two different recovery points after stroke. The early in recovery subgroup will recruit participants 3 to 14 days post stroke and late in recovery subgroup will recruit participants 3 to 24 months post stroke. At time of consent, participants will be allocated a dose of therapy to test, and their response will determine the dose to be tested with future participants. We expect this study to provide answers to the question, what is the tolerable dose of upper limb training and support better development of intervention protocols for testing with stroke survivors in clinical trials.
Interventions
DOSE-UP includes two arms: EARLY recruiting people 3 to 14 days after stroke and LATE recruiting people 3 to 24 months after stroke.
WHAT intervention and WHY:
The intervention will be a combination of impairment and task-specific, upper limb motor training. An example of an impairment-based exercise would be repetitive practice of wrist extension whereas a task specific exercise would be repetitive practice of reaching for a cup. The rationale for this decision is based on optimal training cha
DOSE-UP includes two arms: EARLY recruiting people 3 to 14 days after stroke and LATE recruiting people 3 to 24 months after stroke. WHAT intervention and WHY: The intervention will be a combination of impairment and task-specific, upper limb motor training. An example of an impairment-based exercise would be repetitive practice of wrist extension whereas a task specific exercise would be repetitive practice of reaching for a cup. The rationale for this decision is based on optimal training characteristics from stroke motor learning literature, Australian National Stroke Foundation Guidelines, and previous findings from stroke recovery trials. WHO: Please refer to eligibility for details of participants involved in the study. The intervention will be delivered by a registered clinicians (e.g. occupational therapist, physiotherapist, exercise physiologist) with experience and training in the established impairment and task-specific, upper limb motor training protocol. HOW EARLY - The mode of therapy will be provided face to face in either fully supervised or semi supervised practice. LATE - The mode of therapy will be provided face to face in either fully supervised or semi supervised practice. WHERE: EARLY - The intervention will be conducted at a listed site(s) or the participant's home (if applicable). LATE: The intervention will be conducted at a listed site(s) or the participant's home (if applicable). The preference is for all intervention to be conducted at a listed site(s). Home based therapy will be considered on a case-by-case basis. The factors contributing to this decision will include, number of other participants on the study, local procedures at listed sites regarding home visiting and location of the participant’s home. WHEN AND HOW MUCH: EARLY - The intervention will be delivered within the first month after stroke. The purpose of the trial is to determine the maximum tolerated dose regimen, therefore “how much” therapy a participant will receive is dependent on which cohort they are recruited too. The duration of the intervention period is 3 days and will be consistent across all cohorts. The number of sessions per day and the session intensity will be manipulated. The starting dose for cohort 1 being 1x15min time on task session per day. LATE - The intervention will start within 3 to 24 months post stroke. The purpose of the trial is to determine the maximum tolerated dose regimen, therefore “how much” therapy a participant will receive is dependent on which cohort they are recruited too. The intervention duration is 3 days and will be consistent across all cohorts. The number of sessions per day and the session length will be manipulated,. The starting dose for cohort 1 is 4x90mins session per day. For both subgroups, the maximum dose will be a total of 360 minutes (6 hours). The dose delivered to cohort 2 and beyond will be based on a dose allocation algorithm individual to both the early and late arm.
Sponsors
University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
EARLY: -Current inpatient at time of recruitment, -Hospital diagnosis of stroke (ischemic or haemorrhagic) confirmed on clinical scanning (CT/MRI), -Acute to early subacute phase of recovery, between 3 to 14 days post stroke onset, -Aged 18 years or over, -Upper limb impairment consistent with manual muscle testing of shoulder abduction and finger extension (SAFE) score of 2 to 7, -Able to follow basic one stage commands in English, -Able to provide written informed consent; note, family or authorised representative consent will be sought from individuals with insufficient comprehension to consent, defined by a score > 5 on Short Portable Mental State test, -Appropriate candidate for therapy in the home if required. LATE: - Discharged from the inpatient hospital setting, - Diagnosis of stroke (ischemic or haemorrhagic), - Late subacute to chronic phase of recovery, between 3 to 24 months post stroke onset, - Aged 18 years or over, - Upper limb impairment consistent with a score of 1 to 3 on the Rating of Everyday Arm-use in the Community and Home (REACH) scale, - Able to follow basic one stage commands in English, - Able to provide written informed consent; note, family or authorised representative consent will be sought from individuals with insufficient comprehension to consent, defined by a score > 5 on Short Portable Mental State test, - Appropriate candidate for therapy in the home if required.
Exclusion criteria
EARLY: -Had a previous stroke(s) with residual deficits at current stroke onset, -Diagnosis of other neurological conditions (e.g., dementia, Parkinson’s Disease, MS) -Palliation of comorbid medical illness which in the opinion of the treating neurologist, it is deemed unlikely the patient will be able to actively participate in training, -Concomitate condition that would interfere with participation (e.g., undergoing radiotherapy), -Planned discharged to a location other than the community, Melbourne Health, Austin Health and Western Health, -Unable to commit to the upper limb training regimen. LATE: - Had a previous stroke(s) with residual upper limb motor deficits present at current stroke onset, - Diagnosis of other neurological condition (e.g., dementia, Parkinson’s Disease, MS), - Concomitate condition that would interfere with participation (e.g., undergoing a radiotherapy), - Unable to travel and commit to the training regimen.
Outcome results
None listed