Mental Practice Efficacy in Stroke-Induced Hemiparesis
| Tracking Information | |||||
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| First Received Date ICMJE | December 4, 2009 | ||||
| Last Updated Date | December 4, 2009 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The Action Research Arm test [ Time Frame: Twice before intervention phase; once directly after intervention phase; once 3 months after intervention phase ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mental Practice Efficacy in Stroke-Induced Hemiparesis | ||||
| Official Title ICMJE | Mental Practice in Chronic Stroke-Induced Hemiparesis | ||||
| Brief Summary | This study will examine whether mentally rehearsing moving one's affected arm after stroke will improve the quality and amount of affected arm movement. The study will enroll 100 people who have experienced a stroke > 1 year ago, and who still have difficulty moving their affected wrists and hands. Eligible subjects also cannot have any implanted devices or metal above the waist. Each patient will receive 10 weeks of therapy targeting their affected arms. Half of the subjects will also be administered mental rehearsal of the exercises that they are physically performing, while the other half will be administered stroke information and information on additional exercises that they can perform targeting their affected arms. Tests of arm movement and use will be given before and after intervention, as well as 3 months after intervention, to measure response to these interventions. We will also administer brain scans before and after intervention. We hypothesize that people receiving the mantal and physical rehearsal will show larger arm movement and use changes. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke-induced he,Iparesis in the Arm | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | September 2014 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:(1) Minimum motor criteria: able to at least actively flex the affected wrist a minimum of 10 degrees and actively flex the MP joints of the thumb, and at least 2 additional MP joints in two additional fingers at least 10 degrees. These movements must be repeated at least 3 times in one minute. Additionally, subjects in this study will have to exhibit the aforementioned active range of motion and a FM score of 28 to be eligible for study inclusion. (2) stroke experienced > 1 year prior to study enrollment; (3) a score > 25 on the Folstein Mini Mental Status Examination (MMSE), (4) age > 21 < 75; (5) have experienced one stroke; (6) discharged from all forms of physical rehabilitation. Exclusion Criteria:(1) < 21 years old; (2) excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale; (3) excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of > 2 on the Modified Ashworth Spasticity Scale;92 (4) currently participating in any experimental rehabilitation or drug studies; (5) mirror movements (i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand); (6) contraindication to a MRI procedure (i.e., metal implants, claustrophobia) |
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| Gender | Both | ||||
| Ages | 21 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01026896 | ||||
| Other Study ID Numbers ICMJE | Mental Practice in Stroke | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Stephen J. Page, University of Cincinnati | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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