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

NCT01180738 | Completed

• 1 other identifier: BWSTTvsOWT_UIndy
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Difficulty Walking

Keywords

chronic stroke; walking training; rehabilitation; body weight supported treadmill training; physical therapy; balance

Outcome Measures

Primary Outcomes (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 Outcomes (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).

Study Arms (2)

Body weight supported treadmill training

ACTIVE COMPARATOR

Behavioral: Body weight supported treadmill training

Overground walking training

ACTIVE COMPARATOR

Behavioral: Overground walking training

Interventions

Body weight supported treadmill training 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.

Body weight supported treadmill training

Overground walking training BEHAVIORAL

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

Overground walking training

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie Miller: lead
• University of Indianapolis: collaborator
• Richard L. Roudebush VA Medical Center: collaborator

Study Sites (1)

University of Indianapolis, Krannert School of Physical Therapy

Indianapolis, Indiana, 46227, United States

Location

MeSH Terms

Conditions

Stroke; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 12, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

US (1)