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Phase 2 N=85 Randomized Single-blind Treatment

Does More Practice Improve Arm Movement After Stroke?

Stroke

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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