Mental Practice in Chronic, Stroke Induced Hemiparesis

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 by Ohio State University

Sponsor:

Information provided by (Responsible Party):

Stephen Page, The Ohio State University

ClinicalTrials.gov Identifier:

NCT01651533

First received: July 23, 2012

Last updated: December 23, 2014

Last verified: December 2014

History of Changes

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, 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 Ohio State University:

Primary Outcome Measures:

Change in 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 (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.


Estimated Enrollment:	100
Study Start Date:	September 2010
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	21 Years to 80 Years (Adult, Senior)
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 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651533

Contacts


Contact: Stephen Page, PhD	614-292-5490	Stephen.Page@osumc.edu

Locations


United States, Ohio
Metrohealth	Recruiting
Cleveland, Ohio, United States
Contact: Margaret Maloney, RN 216-778-8563 mmaloney@metrohealth.org
The Ohio State University	Recruiting
Columbus, Ohio, United States
Contact: Stephen Page, PhD 614-292-5490 Stephen.Page@osumc.edu
Principal Investigator: Stephen Page, PhD

Sponsors and Collaborators

Stephen Page

Investigators


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

More Information


Responsible Party:	Stephen Page, Associate Professor School of Health and Rehabilitation Sciences Division of Occupational Therapy, The Ohio State University
ClinicalTrials.gov Identifier:	NCT01651533 History of Changes
Obsolete Identifiers:	NCT01308398
Other Study ID Numbers:	2011H0216
Study First Received:	July 23, 2012
Last Updated:	December 23, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:


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 September 26, 2016

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