Mental Practice in Chronic, Stroke Induced Hemiparesis

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

Tracking Information

• First Submitted Date: July 23, 2012
• First Posted Date: July 27, 2012
• Last Update Posted Date: January 5, 2017
• Study Start Date: September 2010
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mental Practice in Chronic, Stroke Induced Hemiparesis
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hemiparesis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2012): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01651533
• Other Study ID Numbers: 2011H0216
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Stephen Page, Ohio State University
• Study Sponsor: Stephen Page
• Collaborators: Not Provided

Investigators

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

• PRS Account: Ohio State University
• Verification Date: January 2017