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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 24, 2002 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date ICMJE | January 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00037895 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training | ||||||||
| Official Title ICMJE | Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training | ||||||||
| Brief Summary | This project seeks to overcome the reduced walking capability, poor health status, decreased functional capacity, and sedentary lifestyle of stroke patients. The specific objectives are to compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation combined with STAT after an acute stroke on: a) gait performance; b) functional outcomes; c) oxygen consumption during a seated task; and finally: d) using Brain Motor Control Assessment to obtain neurophysiological characteristics, as possible predictors of rehabilitation outcomes. |
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| Detailed Description | Gait training is often delayed during the rehabilitation process because gait is thought to require preparation such as improved strength, balance, and coordination before the initiation of this more complex and demanding activity. We propose a new approach to perform early gait training with acute stroke patients, which consists of Supported Treadmill Ambulation Training (STAT) combined with conventional rehabilitation for achieving functional ambulation. Hypotheses: This study will test three hypotheses;
Specific Objectives and Projected Timetable: Since stroke patients have reduced walking capability, poor health status, decreased functional capacity, as well as a sedentary lifestyle, the specific objectives of this project are:
Timetable: This 3-year project will compare the outcomes between two strategies of intervention during stroke rehabilitation. Admission, randomization, testing, intervention, reevaluation, and discharge will follow the time frame established by the facility while providing regular rehabilitation care for stroke patients. On average, the stroke rehabilitation process lasts two to three weeks. |
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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 | Cerebrovascular Accident | ||||||||
| Intervention ICMJE | Procedure: Ambulation training | ||||||||
| 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 | 48 | ||||||||
| Completion Date | December 2003 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Recent unilateral stroke patients |
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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 | NCT00037895 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | B2340R | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | May 2002 | ||||||||
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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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