Mental Practice in Chronic, Stroke Induced Hemiparesis

NCT01651533 | Completed DMC

• 1 other identifier: 2011H0216
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Keywords

Mental practice group; Active control group

Outcome Measures

Primary Outcomes (1)

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

  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.

  2-3 weeks before intervention; 1 week after intervention; 3 months after intervention

Study Arms (2)

Experimental: Mental Practice Group

EXPERIMENTAL

Behavioral: Mental Practice Group

Active Comparator: Active Control Group

ACTIVE COMPARATOR

Behavioral: Active Control Group

Interventions

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.

Experimental: Mental Practice Group

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.

Active Comparator: Active Control Group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (2)

Metrohealth

Cleveland, Ohio, United States

Location

The Ohio State University

Columbus, Ohio, United States

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Page, PhD,M.S.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 27, 2012
• Study Start: September 1, 2010
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

US (2)