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

Sponsor
Stephanie Miller (Other)
Overall Status
Completed
CT.gov ID
NCT01180738
Collaborator
University of Indianapolis (Other), Richard L. Roudebush VA Medical Center (U.S. Fed)
20
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16
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Body weight supported treadmill training
  • Behavioral: Overground walking training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Indianapolis, Krannert School of Physical Therapy Indianapolis Indiana United States 46227

Sponsors and Collaborators

  • Stephanie Miller
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephanie Miller, Professor, University of Indianapolis
ClinicalTrials.gov Identifier:
NCT01180738
Other Study ID Numbers:
  • BWSTTvsOWT_UIndy
First Posted:
Aug 12, 2010
Last Update Posted:
Apr 2, 2020
Last Verified:
Mar 1, 2020
Keywords provided by Stephanie Miller, Professor, University of Indianapolis
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2020