Mental Practice in Chronic, Stroke Induced Hemiparesis

NCT ID: NCT01651533

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental: Mental Practice Group

Group Type: EXPERIMENTAL

Mental Practice Group

Intervention Type: 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 Comparator: Active Control Group

Group Type: ACTIVE_COMPARATOR

Active Control Group

Intervention Type: 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.

Interventions

Mental Practice Group

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.

Intervention Type: BEHAVIORAL

Active Control Group

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Page, PhD,M.S.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Metrohealth

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2011H0216

Identifier Type: -

Identifier Source: org_study_id

NCT01026896

Identifier Type: -

Identifier Source: nct_alias

NCT01308398

Identifier Type: -

Identifier Source: nct_alias