Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00037895

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident	Procedure: Ambulation training	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

Study Start Date :

Jan 1, 2001

Actual Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Recent unilateral stroke patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VAMC	Houston	Texas	United States

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

: David Wolff, Ph.D., Special Assistant to the Director, Program Analysis and Review Section (PARS) VA Rehabilitation Research & Development Service
: Danielle Kerkovitch, Ph.D., Program Analysis and Review Section (PARS), VA Rehabilitation Research and development Service