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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | November 9, 2009 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | September 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00013481 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Coordination of Hemiparetic Movement After Post-Stroke Rehabilitation | ||||
| Official Title ICMJE | Coordination of Hemiparetic Movement After Post-Stroke Rehabilitation | ||||
| Brief Summary | This study will determine whether a therapeutic exercise program for improving motor coordination in locomotor tasks in post-stroke, hemiparesis patients will result in CNS recovery. The study will develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables.) |
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| Detailed Description | Primary objective of this study is to determine whether a therapeutic exercise program which targets the functional recovery of persons with the post-stroke hemiparesis results in CNS recovery (improved motor coordination). They will determine whether motor coordination during a locomotor task is improved after an exercise program. They will then develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables) Overall goal is to develop a more rational basis for the design of stroke rehabilitation programs which target individuals most likely to recover and which are based on physiological principles. This study will supplement an NIH funded randomized clinical trial to evaluate a post-stroke exercise program designed to increase balance, strength, and endurance. Study will include 60-70 prospective patients enrolled in the randomized clinical trial at Kansas University Center on Aging. between Oct 1999 and Oct 2001. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Stroke | ||||
| Intervention ICMJE | Procedure: Stroke Rehabilitation | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Completion Date | September 2003 | ||||
| Primary Completion Date | September 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Functionally impaired elderly Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| 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 ID ICMJE | NCT00013481 | ||||
| Responsible Party | Duncan, Pamela - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | E2116 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | November 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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