Phase 2
N=85
Does More Practice Improve Arm Movement After Stroke?
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01146379 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Change in Action Research Arm Test (ARAT) Score Per Week — 0.4; -0.05; 0.31; 0.66 change in units on a scale/week — p=.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intensive task-specific upper extremity rehabilitation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Action Research Arm Test (ARAT) Score Per Week |
0.4; -0.05; 0.31; 0.66 | .01 sig |
Summary
Arm weakness happens a lot after a stroke. People often get physical or occupational therapy after their stroke to learn how to use their arm again. This study will help figure out how much therapy should be given to restore as much arm function as possible.
Eligibility Criteria
Inclusion Criteria
- Ischemic or hemorrhagic stroke as determined by a stroke neurologist and consistent with neuroimaging
- Time since stroke will include subjects 6-months or more post-stroke
- Cognitive skills to actively participate (score of 0-1 on items 1b and 1c of the NIH Stroke Scale (NIHSS)
- Unilateral upper extremity weakness (score of 1-3 on item 5 (arm item) on the NIHSS)
Exclusion Criteria
- Subject unavailable for 2-month follow-up
- Inability to follow-2-step commands
- Psychiatric diagnoses
- Current participation in other stroke treatment (i.e.- Botox)
- Other neurological diagnoses
- If participant lives further than one hour away and is unwilling to travel for assessment and treatment sessions.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01146379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.