Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
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|ClinicalTrials.gov Identifier: NCT00037895|
Recruitment Status : Completed
First Posted : May 27, 2002
Last Update Posted : January 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident||Procedure: Ambulation training||Phase 2|
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;
- The STAT group will develop greater gait speed, longer walking endurance, and lower oxygen costs for walking as compared to stroke patients receiving regular rehabilitation care.
- The STAT group will develop better functional outcomes (Functional Independence Measurement total scores and on the transfers and locomotion subscales) as compared to stroke patients receiving regular rehabilitation care.
- The STAT group will develop higher submaximal oxygen consumption as measured on a bicycle ergometer test compared to stroke patients receiving regular rehabilitation care.
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:
- Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on gait performance;
- Compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation combined with STAT after an acute stroke on functional outcomes, as defined by the Functional Independence Measure (FIM);
- Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on the oxygen consumption during a seated exercise task.
- Explore whether neurophysiological characteristics using the Brain Motor Control Assessment (BMCA) predict rehabilitation outcomes.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training|
|Study Start Date :||January 2001|
|Actual Study Completion Date :||December 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037895
|United States, Texas|
|Houston, Texas, United States|
|OverallOfficial:||David Wolff, Ph.D., Special Assistant to the Director||Program Analysis and Review Section (PARS) VA Rehabilitation Research & Development Service|
|OverallOfficial:||Danielle Kerkovitch, Ph.D.||Program Analysis and Review Section (PARS), VA Rehabilitation Research and development Service|