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

NCT ID: NCT01180738

Last Updated: 2020-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Stroke Difficulty Walking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Body weight supported treadmill training

Group Type ACTIVE_COMPARATOR

Body weight supported treadmill training

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Overground walking training

Intervention Type BEHAVIORAL

Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.

Interventions

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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.

Intervention Type BEHAVIORAL

Overground walking training

Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Indianapolis

OTHER

Sponsor Role collaborator

Richard L. Roudebush VA Medical Center

FED

Sponsor Role collaborator

Stephanie Miller

OTHER

Sponsor Role lead

Responsible Party

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Stephanie Miller

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Stephanie A Combs, PT, PhD, NCS

Role: PRINCIPAL_INVESTIGATOR

University of Indianapolis, Krannert School of Physical Therapy, Indianapolis, IN

Arlene A Schmid, OTR, PhD

Role: PRINCIPAL_INVESTIGATOR

Co-Investigator, Roudebush VA Medical Center, Indianapolis, IN

Locations

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University of Indianapolis, Krannert School of Physical Therapy

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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BWSTTvsOWT_UIndy

Identifier Type: -

Identifier Source: org_study_id

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