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Completed

NCT Number: NCT01180738

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Difficulty Walking Mobility Limitation Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Indianapolis, Krannert School of Physical Therapy

Indianapolis, Indiana, 46227, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Overground walking training

Behavioral

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

Primary outcomes

  1. 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 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

    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).

Sponsors and collaborators

Lead sponsor

Stephanie Miller

Other

Collaborators

  • Richard L. Roudebush VA Medical Center
  • University of Indianapolis

Registry information

Official study title

Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 12, 2010
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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