Mental Practice in Chronic, Stroke Induced Hemiparesis

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.

Study Overview

• Status: Completed
• Conditions: Hemiparesis
• Intervention / Treatment: Behavioral: Mental Practice Group; Behavioral: Active Control Group

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States
      • MetroHealth
    • Columbus, Ohio, United States
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Mental Practice Group	Behavioral: 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.
Active Comparator: Active Comparator: Active Control Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Stephen Page, PhD,M.S., Ohio State University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Active control group; Mental practice group
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 2011H0216