Mental Practice in Chronic, Stroke Induced Hemiparesis

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.

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Key information

Conditions

Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metrohealth, Cleveland, Ohio, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental Practice Group

Behavioral

Patients are administered rehabilitative therapy targeting their affected arms on 3 days/week during a ten week period. Directly after the therapy session, they participate in targeted mental practice session in which they cognitively rehearse the movement that they just physically practiced.

Active Control Group

Behavioral

Individuals assigned to this group are administrated rehabilitative therapy targeting their affected arms in half four increments, occurring 3 days/week for 10 weeks. They also are administered an intervention in which they listen to a relaxation tape and/or tapes in which they receive instructions on exercises and information on stroke care.

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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Mental Practice in Chronic, Stroke-Induced Hemiparesis

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Jul 27, 2012
Registry last updated: Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed