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

This study has been completed.
Sponsor:
Collaborators:
University of Indianapolis
Richard L. Roudebush VA Medical Center
Information provided by (Responsible Party):
Stephanie Combs, University of Indianapolis
ClinicalTrials.gov Identifier:
NCT01180738
First received: August 9, 2010
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Stroke
Difficulty Walking
 Behavioral: Body weight supported treadmill training
Behavioral: Overground walking training
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by University of Indianapolis:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180738

Locations
United States, Indiana
University of Indianapolis, Krannert School of Physical Therapy
Indianapolis, Indiana, United States, 46227
Sponsors and Collaborators
Stephanie Combs
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
  More Information

No publications provided

Responsible Party: Stephanie Combs, Assistant Professor, University of Indianapolis
ClinicalTrials.gov Identifier: NCT01180738     History of Changes
Other Study ID Numbers: BWSTTvsOWT_UIndy
Study First Received: August 9, 2010
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Indianapolis:
chronic stroke
walking training
rehabilitation
 body weight supported treadmill training
physical therapy
balance

Additional relevant MeSH terms:
Body Weight
Stroke
Cerebral Infarction
Mobility Limitation
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 22, 2013