Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ambulation training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Stroke, Ambulation Training, Rehabilitation, Treadmill
Eligibility Criteria
Recent unilateral stroke patients
Sites / Locations
- VAMC
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037895
First Posted
May 24, 2002
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00037895
Brief Title
Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
Official Title
Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
Study Type
Interventional
2. Study Status
Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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.
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;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke, Ambulation Training, Rehabilitation, Treadmill
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Ambulation training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Recent unilateral stroke patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wolff, Ph.D., Special Assistant to the Director
Organizational Affiliation
Program Analysis and Review Section (PARS) VA Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Danielle Kerkovitch, Ph.D.
Organizational Affiliation
Program Analysis and Review Section (PARS), VA Rehabilitation Research and development Service
Facility Information:
Facility Name
VAMC
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
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Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
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