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N/A N=103 Randomized Single-blind Treatment

Patient Targeted Upper Extremity Rehabilitation After Stroke

Stroke

Enrolled (actual)
103
Serious AEs
1.9%
Results posted
Jun 2019
Primary outcome: Primary: Fugl-Meyer Assessment of the Upper Extremity — 4.08; 2.45 score on a scale — p=0.912

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Task Practice Physical Rehabilitation Therapy (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Mar 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Fugl-Meyer Assessment of the Upper Extremity
4.08; 2.45 0.912
PRIMARY
Wolf Motor Function Test
-4.81; -6.51
SECONDARY
Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations

Summary

Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. This study will investigate the effects of a challenging 4-week physical rehabilitation therapy program that is targeted at specific movement impairments and systematically progressed to assure an ongoing "just right" level of rigor. The investigators anticipate that therapy targeted to address specific movement impairments will improve recovery of arm/hand movement in people who have had a stroke.

Eligibility Criteria

Inclusion Criteria

Individuals are eligible for this study if they have:

  • experienced a stroke at least 3 months prior that has resulted in unilateral hemiparesis.
  • exhibit voluntarily paretic arm shoulder flexion 30 degrees with simultaneous elbow extension 20 degrees.
  • impairment with overhead reach and wrist circumduction and fine motor dexterity.
  • passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Exclusion Criteria

Individuals are not eligible for this study if they have:

  • a lesion in the brainstem or cerebellum.
  • another neurological disease that may impair motor skills (e.g., Parkinson's Disease).
  • pain in the affected upper extremity that would limit participation in the study intervention.
  • difficulty understanding and following 3-step directions.
  • difficulty sitting independently without postural support.
  • an orthopedic condition or impaired corrected vision that alters the kinematics of reaching.
  • are unable to travel to and remain in Charleston SC for the duration of the 4-week study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01819506). 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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