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

March 31, 2020 updated by: Stephanie Miller

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • University of Indianapolis, Krannert School of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Body weight supported treadmill training
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.
ACTIVE_COMPARATOR: Overground walking training
Behavioral: Overground walking training
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gait speed: measured with the comfortable 10-meter walk test
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Time Frame
Gait endurance: measured with the 6-minute walk test; Fear of falling: measured with the Fear of Falling questionnaire and Falls Efficacy Scale-International
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephanie Miller

Collaborators

University of Indianapolis
Richard L. Roudebush VA Medical Center

Investigators

  • Principal Investigator: Stephanie A Combs, PT, PhD, NCS, University of Indianapolis, Krannert School of Physical Therapy, Indianapolis, IN
  • Principal Investigator: Arlene A Schmid, OTR, PhD, Co-Investigator, Roudebush VA Medical Center, Indianapolis, IN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (ESTIMATE)

August 12, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWSTTvsOWT_UIndy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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