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Mental Practice in Chronic, Stroke Induced Hemiparesis

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ClinicalTrials.gov Identifier: NCT01651533
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Stephen Page, Ohio State University

Tracking Information
First Submitted Date  ICMJE July 23, 2012
First Posted Date  ICMJE July 27, 2012
Last Update Posted Date January 5, 2017
Study Start Date  ICMJE September 2010
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mental Practice in Chronic, Stroke Induced Hemiparesis
Official Title  ICMJE Mental Practice in Chronic, Stroke-Induced Hemiparesis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemiparesis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Experimental: Mental Practice Group
    Intervention: Behavioral: Mental Practice Group
  • Active Comparator: Active Comparator: Active Control Group
    Intervention: Behavioral: Active Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01651533
Other Study ID Numbers  ICMJE 2011H0216
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Page, Ohio State University
Study Sponsor  ICMJE Stephen Page
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Page, PhD,M.S. Ohio State University
PRS Account Ohio State University
Verification Date January 2017

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