Responses to Backward Walking Training Post-Stroke

NCT04928482 | Recruiting

• 1 other identifier: B3542-R
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Change in the time to complete the 10 Meter walk Test

  Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.

  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

  BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.

  Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)

• Change in the Functional Gait Assessment

  A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.

  Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)

• Change in the Activity-Specific Balance Confidence Scale

  This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.

  Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)

• Change in the Berg Balance Scale

  This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.

  Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)

Secondary Outcomes (5)

• Change in the time to complete the 10 Meter walk Test

  Change from baseline through study completion, an average of 7 months.

• Change in the time to complete the Three-Meter Backward Walk Test

  Change from baseline through study completion, an average of 7 months.

• Change in the Functional Gait Assessment

  Change from baseline through study completion, an average of 7 months.

• Change in the Activity-Specific Balance Confidence Scale

  Change from baseline through study completion, an average of 7 months.

• Change in the Berg Balance Scale

  Change from baseline through study completion, an average of 7 months.

Study Arms (2)

27 session group

EXPERIMENTAL

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

Behavioral: Backward Walking Training

18 session group

ACTIVE COMPARATOR

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

Behavioral: Backward Walking Training

Interventions

Backward Walking Training BEHAVIORAL

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.

27 session group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

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

Gainesville, Florida, 32608-1135, United States

RECRUITING

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dorian Kay Rose, PhD MS BS

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorian K Rose, PhD MS BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessors will be masked to group assignment. Outcome Assessors will not deliver the intervention and will not be present in the building when the intervention is being delivered. Participants will be instructed to not reveal their group assignment to the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive either: 1) 27 sessions of backward walking training or 2) 18 sessions of backward walking training

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: November 8, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)