Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke

Stroke Clinical Trial

Official title:

Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180738
• Other study ID #: BWSTTvsOWT_UIndy
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2020
• Source: University of Indianapolis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two different walking training programs for persons with chronic stroke.

Description:

Body weight supported treadmill training (BWSTT) and overground walking training (OWT) are two interventions commonly applied for enhancing gait and balance in patients with chronic stroke. BWSTT and OWT are often used by clinicians separately or in tandem. While various aspects of the two interventions have been investigated in the past, limited research has been conducted to compare the effects of the two interventions in patients with chronic stroke.

Longer training durations may not always be feasible due to limited reimbursement options, lack of clinic accessibility, or transportation restrictions for patients with chronic deficits following stroke. A short burst of training consisting of a ''booster''-like protocol may provide a convenient option for some patients with chronic stroke to improve necessary functional skills in a short period of time.

The primary purpose of this pilot study is to compare walking speed immediately and 3-months after a short-burst of body-weight support treadmill training (BWSTT) or overground walking training (OWT) for adults with chronic stroke. Twenty participants with chronic stroke will be recruited and screened to determine eligibility for the study. Participants will be randomly assigned to either BWSTT or OWT for 30 minutes, 5 days per week for 2 weeks. Outcome measures will include assessments of gait speed, endurance, walking pattern, fear of falling, balance confidence, anxiety, and activity and participation in daily life. Outcomes will be tested prior to (pre-test) and immediately after (post-test) the assigned intervention and again 3-months after completing the intervention (retention).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Minimum of 6 months post-stroke

• Single episode of stroke

• Between the ages of 21-80

• Able to walk with or without the use of an assistive device or orthoses

• Able to ambulate at a self-selected gait speed < 0.8 m/s as determined by the 10-meter comfortable walk test

• Medically stable with a physician release stating approval to enter an exercise program

• Able to follow at least two-step verbal instructions

• Available for the entire period of the study

• Able to travel to and from research measurement and intervention sessions

Exclusion Criteria:

• Currently receiving physical therapy services

• Co-morbidities or pre-existing cardiovascular conditions that would prohibit gait training and exercise

• Pre-existing neurological or current musculoskeletal conditions that would limit gait ability separate from the effects of stroke

• Complications from other health conditions that could influence walking

• Currently known to be pregnant

Related Conditions & MeSH terms

• Body Weight
• Difficulty Walking
• Mobility Limitation
• Stroke

Intervention

Behavioral:
• Body weight supported treadmill training
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking on a treadmill using a body weight support system.
• Overground walking training
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.

Locations

Country	Name	City	State
United States	University of Indianapolis, Krannert School of Physical Therapy	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Stephanie Miller	Richard L. Roudebush VA Medical Center, University of Indianapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed: measured with the comfortable 10-meter walk test		The outcome measure will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).
Secondary	Gait endurance: measured with the 6-minute walk test; Fear of falling: measured with the Fear of Falling questionnaire and Falls Efficacy Scale-International		The outcome measures will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).