Mental Practice in Chronic, Stroke Induced Hemiparesis

Hemiparesis Clinical Trial

Official title:

Mental Practice in Chronic, Stroke-Induced Hemiparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651533
• Other study ID #: 2011H0216
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2016

Study information

• Verified date: February 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01026896
• NCT01308398

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis

Intervention

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 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.

Locations

Country	Name	City	State
United States	Metrohealth	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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