Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

Cerebrovascular Accident Clinical Trial

Official title:

Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037895
• Other study ID #: B2340R
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2002
• Last updated: January 20, 2009
• Start date: January 2001
• Est. completion date: December 2003

Study information

• Verified date: May 2002
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: Recent unilateral stroke patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Procedure:
• Ambulation training

Locations

Country	Name	City	State
United States	VAMC	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,