Mental Practice in Chronic, Stroke Induced Hemiparesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 14, 2014
Last verified: May 2014

July 23, 2012
May 14, 2014
September 2010
January 2015   (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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01651533 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Hemiparesis
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2015
January 2015   (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
Both
21 Years to 80 Years
No
Contact: Stephen Page, PhD 614-292-5490 Stephen.Page@osumc.edu
United States
 
NCT01651533
2011H0216
Yes
Stephen Page, The Ohio State University
Stephen Page
Not Provided
Principal Investigator: Stephen Page, PhD,M.S. Ohio State University
Ohio State University
May 2014

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