Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00037895
First received: May 24, 2002
Last updated: January 20, 2009
Last verified: May 2002

May 24, 2002
January 20, 2009
January 2001
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Complete list of historical versions of study NCT00037895 on ClinicalTrials.gov Archive Site
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Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

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.

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;

  1. 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.
  2. 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.
  3. 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:

  1. Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on gait performance;
  2. 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);
  3. 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.
  4. 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebrovascular Accident
Procedure: Ambulation training
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2003
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Recent unilateral stroke patients

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00037895
B2340R
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Department of Veterans Affairs
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Investigator: David Wolff, Ph.D., Special Assistant to the Director Program Analysis and Review Section (PARS) VA Rehabilitation Research & Development Service
Investigator: Danielle Kerkovitch, Ph.D. Program Analysis and Review Section (PARS), VA Rehabilitation Research and development Service
Department of Veterans Affairs
May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP