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Clinical Trials/NCT01651533
NCT01651533
Completed
Not Applicable

Mental Practice in Chronic, Stroke-Induced Hemiparesis

Ohio State University2 sites in 1 country100 target enrollmentSeptember 2010
ConditionsHemiparesis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiparesis
Sponsor
Ohio State University
Enrollment
100
Locations
2
Primary Endpoint
Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing arm disability and increasing function, thereby improving outcomes and health, reducing care costs, for community dwelling patients with stroke-induced hemiparesis.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
December 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • a Fugl-Meyer score \> 27, which is indicative of minimal to moderate arm impairment;
  • stroke experienced \> 6 months prior to study enrollment;
  • minimal cognitive impairment, a score \> 25 on the Folstein Mini Mental Status Examination (MMSE);
  • age \> 21 years old and \< 80 years old;
  • have experienced one clinical stroke as verified by a physician;
  • discharged from all forms of physical rehabilitation targeting the affected arm.

Exclusion Criteria

  • \< 21 years old;
  • excessive pain in the affected hand, arm or shoulder, as measured by a score \> 5 on a 10-point visual analog scale;
  • excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of greater than or equal to 2 on the Modified Ashworth Spasticity Scale;
  • currently participating in any experimental rehabilitation or drug studies targeting UE;
  • mirrors movements(i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand during attempts at unilateral movement by the stroke-affected hand);
  • history of parietal stroke (because some data suggest that ability to estimate manual motor performance through mental imagery is disturbed after parietal lobe damage);
  • affected arm joint restriction that in the opinion of the investigator would hinder study participation

Outcomes

Primary Outcomes

Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test

Time Frame: 2-3 weeks before intervention; 1 week after intervention; 3 months after intervention

This is a measure that examines the participant's ability to use the affected wrist and fingers to grasp, pinch, and grip small objects (i.e., fine motor skills). Gross movements(e.g., touching the top of the head using the affected arm) are also briefly examined. The investigator will measure changes in these abilities. We will do this by administering the measure before and after participation in the study to determine if a change occurred in patients' movement abilities.

Study Sites (2)

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