Back to resultsMental Practice in Chronic, Stroke Induced Hemiparesis
Primary Purpose
Hemiparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mental Practice Group
Active Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring Mental practice group, Active control group
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
Sites / Locations
- Metrohealth
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: Mental Practice Group
Active Comparator: Active Control Group
Arm Description
Outcomes
Primary Outcome Measures
Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01651533
Brief Title
Mental Practice in Chronic, Stroke Induced Hemiparesis
Official Title
Mental Practice in Chronic, Stroke-Induced Hemiparesis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis
Keywords
Mental practice group, Active control group
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Mental Practice Group
Arm Type
Experimental
Arm Title
Active Comparator: Active Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mental Practice Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test
Description
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.
Time Frame
2-3 weeks before intervention; 1 week after intervention; 3 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Page, PhD,M.S.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metrohealth
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mental Practice in Chronic, Stroke Induced Hemiparesis
We'll reach out to this number within 24 hrs