Improving walking ability after spinal cord injury with early treadmill therapy
Official title: Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training
Run by Shirley Ryan AbilityLab · NCT06176833 · Data updated 2026-11-12
This study tests if starting treadmill therapy sooner after a spinal cord injury can help people walk better compared to starting later or not at all.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 75 Years |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | March 21, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT06176833 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 16-74 with acute traumatic spinal cord injuries classified as AIS B, C, or D.
✕Probably not a fit
Patients with orthopedic injuries, severe cognitive impairments, or those exceeding weight limits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the impact of body weight supported treadmill training (BWSTT) on walking ability in individuals with traumatic spinal cord injuries. Participants will be randomized into four groups based on when they start the therapy: within 60 days, within 3 months, within 6 months, or not at all. The goal is to determine if the timing of initiating this therapy within the first six months post-injury affects its effectiveness. The study aims to enhance recovery outcomes by understanding the optimal timing for this intervention.
Why it matters
Potential benefit: If successful, this study could lead to improved walking abilities and recovery outcomes for individuals with spinal cord injuries.
How similar studies have gone: Previous studies have shown promise in using early locomotor interventions for spinal cord injuries, but this specific timing approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12 * Between the ages of 16-74 * Weight bearing as tolerated in bilateral lower extremities * Able to tolerate a harness * Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor * Able to provide informed consent within 60 days of injury onset * Able to participate in all study related activities, including 1-year follow up Exclusion Criteria: * Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing * A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus * Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition * Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program. * Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation * Pregnancy, as confirmed by blood draw
Where it's running
-
The Shirley Ryan AbilityLab
Chicago, Illinois, United States Recruiting -
Baylor Scott and White Institute for Rehabilitation
Fort Worth, Texas, United States Not yet recruiting
Study contacts
- Principal investigator: Milap Sandhu, PhD — Shirley Ryan AbilityLab
- Study coordinator: Alexander Barry, MS, CCRC
- Email: abarry@sralab.org
- Phone: 3122381435
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.