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
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Procedure: Ambulation training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 48
Study Start Date: January 2001
Study Completion Date: December 2003
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;

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Recent unilateral stroke patients

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00037895

Locations
United States, Texas
VAMC
Houston, Texas, United States
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00037895     History of Changes
Other Study ID Numbers: B2340R
Study First Received: May 24, 2002
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stroke
Ambulation Training
Rehabilitation
Treadmill

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014