Mental Practice in Chronic, Stroke Induced Hemiparesis

Not Applicable

Completed

• Conditions: Hemiparesis
• Interventions: Behavioral: Active Control Group; Behavioral: Mental Practice Group

• Registration Number: NCT01651533
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-27
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Active Control Group	Active Control Group	-
Experimental: Mental Practice Group	Mental Practice Group	-

Primary Outcome Measures

Name	Time	Method
Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test	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.

Trial Locations

Locations (2)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Metrohealth; 🇺🇸 Cleveland, Ohio, United States