Mental Practice in Chronic, Stroke Induced Hemiparesis

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT01651533
Collaborator
(none)
100
2
2
75
50
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mental Practice Group
  • Behavioral: Active Control Group
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mental Practice in Chronic, Stroke-Induced Hemiparesis
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test [2-3 weeks before intervention; 1 week after intervention; 3 months after intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Metrohealth Cleveland Ohio United States
2 The Ohio State University Columbus Ohio United States

Sponsors and Collaborators

  • Ohio State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ohio State University
ClinicalTrials.gov Identifier:
NCT01651533
Other Study ID Numbers:
  • 2011H0216
  • NCT01026896
  • NCT01308398
First Posted:
Jul 27, 2012
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Keywords provided by Ohio State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022