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Clinical Trials/ACTRN12620000215921
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.

Registry
who.int
Start Date
February 24, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Melbourne

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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