Recruiting

Backward Walking Training

Sponsor:

VA Office of Research and Development

Code:

NCT04928482

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Backward Walking Training

Backward Walking Training

Study Details

Brief summary:

Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. The investigators have previously established the effectiveness of a backward walking training program to improve gait and balance in post-stroke Veterans. To best serve Veterans in this era of personalized medicine, there is a current need to determine the appropriate training dose as well as which post-stroke Veterans would most benefit. This study addresses both needs as it will 1) test responses to two different doses (18 vs. 27 sessions) of backward walking training and 2) assess brain activity, measured by magnetic resonance imaging, before and after training intervention to determine its ability to predict rehabilitation response as well as brain mechanisms of behavioral change.

Conditions

Stroke

Study ID

NCT04928482

Start date

Nov 8, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 27 session group

Participants in this arm will receive 27 sessions of backward walking training.

active comparator: 18 session group

Participants in this arm will receive 18 sessions of backward walking training.

Interventions

Backward Walking Training

Participants will receive 27 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.

Backward Walking Training

Participants will receive 18 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.

Primary outcome measure

  • Change in the time to complete the 10 Meter walk Test [ Time Frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm) ]
  • Change in the time to complete the Three-Meter Backward Walk Test [ Time Frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm) ]
  • Change in the Functional Gait Assessment [ Time Frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm) ]
  • Change in the Activity-Specific Balance Confidence Scale [ Time Frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm) ]
  • Change in the Berg Balance Scale [ Time Frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm) ]

Central Contacts and Locations

Central contacts

Dorian K Rose, PhD MS BS

(352) 273-8307Dorian.Rose@va.gov

Locations

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

Recruiting

Gainesville, Florida, United States, 32608-1135

Contacts

Dorian K Rose, PhD MS BS

(352) 273-8307Dorian.Rose@va.gov

Principal Investigator:

Dorian Kay Rose, PhD MS BS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-08.