Clinical Trial

Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury

Study acronym: PROPEL-SCI
Recruiting
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Summary
The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy. The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-12 -> 2028-12 2026-07-07
minor Completion pushed: 2028-12 -> 2029-12 2026-07-07
Trial Details
NCT Number NCT06176833
Lead Sponsor Milap Sandhu
Collaborators: Baylor Scott and White Health, University of Florida, Congressionally Directed Medical Research Programs
Conditions Spinal Cord Injuries
Enrollment 108 participants
Start Date 2024-03-21
Primary Completion 2028-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-06