Mental Practice in Chronic, Stroke-Induced Hemiparesis - Full Text View

Purpose

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, and reducing care costs, for community dwelling patients with stroke-induced hemiparesis.

Condition	Intervention	Phase
Hemiparesis	Behavioral: Mental Practice Group Behavioral: Active Control Group	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Mental Practice in Chronic, Stroke-Induced Hemiparesis

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
This is a measure that examines the participant's ability to use the affected wrist and fingers to grasp, pinch, and grip small objects (ie, fine motor skills). Gross movements (e.g., touching the top of the head using the affected arm) are also briefly examined. The investigators will measure these abilities before and after participation in the study to determine if a change occurred in patients' movement abilities.

Enrollment:	17
Study Start Date:	September 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 sessions, they participate in targeted mental practice sessions in which they cognitively rehearse the movements that they just physically practiced.
Active Comparator: Active Control Group	Behavioral: Active Control Group Individuals assigned to this group are administered rehabilitative therapy targeting their affected arms in half hour 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.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 the UE
mirror movements (i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand)
history of a 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308398

Locations

United States, Ohio
Metrohealth
Cleveland, Ohio, United States, 44109
The Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

University of Cincinnati

More Information

No publications provided

Responsible Party:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT01308398 History of Changes
Other Study ID Numbers:	1R01AT004454-01A1
Study First Received:	February 11, 2011
Last Updated:	June 12, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

Mental practice group
Active control group

Additional relevant MeSH terms:

Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013