Mental Practice in Chronic, Stroke Induced Hemiparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01651533
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : January 5, 2017
Information provided by (Responsible Party):
Stephen Page, The Ohio State University

July 23, 2012
July 27, 2012
January 5, 2017
September 2010
August 2016   (Final data collection date for primary outcome measure)
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 ]
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.
Same as current
Complete list of historical versions of study NCT01651533 on Archive Site
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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.
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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • 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.
  • 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.
  • Experimental: Experimental: Mental Practice Group
    Intervention: Behavioral: Mental Practice Group
  • Active Comparator: Active Comparator: Active Control Group
    Intervention: Behavioral: Active Control Group
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2016
August 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Stephen Page, The Ohio State University
Stephen Page
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Principal Investigator: Stephen Page, PhD,M.S. Ohio State University
Ohio State University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP