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Search / Trial NCT04928482

Responses to Backward Walking Training Post-Stroke

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 9, 2021

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Rehabilitation Gait Physical Therapy Modalities Magnetic Resonance Imaging Postural Balance Accidental Falls

ClinConnect Summary

This clinical trial is studying a special training program that involves walking backward to help improve balance and walking ability in veterans who have had a stroke. Researchers want to find out how many sessions of this backward walking training are most effective—either 18 or 27 sessions. They will also look at brain activity using a type of scan called magnetic resonance imaging (MRI) to see how the brain responds to the training and which veterans benefit the most from it.

To participate in this study, veterans must be between 65 and 87 years old, have had a stroke more than two months but less than four months ago, and have some difficulty walking or balancing. They should be able to walk at least 10 feet with minimal assistance. Participants will receive the backward walking training and undergo MRI scans before and after the training to help researchers understand how well the program works. It's important to know that certain health conditions, like severe heart problems or other neurological issues, may prevent someone from joining the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Berg Balance Scale \< 45
  • Self-selected 10 meter gait speed \< 0.8 m/s
  • Diagnosis of unilateral stroke
  • \> 2 months \< 4 months post-stroke
  • Able to ambulate at least 10 feet with maximum 1 person assist
  • Medically stable
  • Exclusion Criteria:
  • Presence of neurological condition other than stroke
  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
  • Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
  • Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10 degrees, knee flexion ROM \< 90 degrees, hip flexion contracture \> 25 degrees, and ankle plantar flexion contracture \> 15 degrees)
  • Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest
  • Pain upon ambulation
  • Receiving physical therapy services for mobility and/or gait
  • Living in a skilled nursing facility
  • Any MRI contraindication, including but not limited to the presence of metal, MR sensitive implanted medical devices, or claustrophobia

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Gainesville, Florida, United States

Jacksonville, Florida, United States

Gainesville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Dorian Kay Rose, PhD MS BS

Principal Investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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