ACTRN12620000215921
Recruiting
Phase 1
DOSE ranging in UPper limb rehabilitation post stroke (DOSE-UP): Phase I trial
niversity of Melbourne0 sites200 target enrollmentFebruary 24, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- niversity of Melbourne
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-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, and
- •\-Appropriate candidate for therapy in the home if required.
- •\-Discharged from the inpatient hospital setting,
- •\-Diagnosis of stroke (ischemic or haemorrhagic),
Exclusion Criteria
- •\-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, or
- •\-Unable to commit to the upper limb training regimen.
- •\-Had a previous stroke(s) with residual motor deficits,
- •\-Diagnosis of other neurological conditions (e.g., dementia, Parkinson’s Disease, MS)
- •\-Concomitate condition that would interfere with participation (e.g., undergoing a treatment radiotherapy), or
- •\-Unable to travel and commit to the upper limb training regimen.
Outcomes
Primary Outcomes
Not specified
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