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

Primary Purpose

Stroke, Difficulty Walking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body weight supported treadmill training
Overground walking training
Sponsored by
Stephanie Miller
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring chronic stroke, walking training, rehabilitation, body weight supported treadmill training, physical therapy, balance

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Indianapolis, Krannert School of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Body weight supported treadmill training

Overground walking training

Arm Description

Outcomes

Primary Outcome Measures

Gait speed: measured with the comfortable 10-meter walk test

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

Full Information

First Posted
August 9, 2010
Last Updated
March 31, 2020
Sponsor
Stephanie Miller
Collaborators
University of Indianapolis, Richard L. Roudebush VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01180738
Brief Title
Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
Official Title
Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephanie Miller
Collaborators
University of Indianapolis, Richard L. Roudebush VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Difficulty Walking
Keywords
chronic stroke, walking training, rehabilitation, body weight supported treadmill training, physical therapy, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body weight supported treadmill training
Arm Type
Active Comparator
Arm Title
Overground walking training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Body weight supported treadmill training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Overground walking training
Intervention Description
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.
Primary Outcome Measure Information:
Title
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).
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie A Combs, PT, PhD, NCS
Organizational Affiliation
University of Indianapolis, Krannert School of Physical Therapy, Indianapolis, IN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arlene A Schmid, OTR, PhD
Organizational Affiliation
Co-Investigator, Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Indianapolis, Krannert School of Physical Therapy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States

12. IPD Sharing Statement

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

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