Actively Recruiting
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
Led by Milap Sandhu · Updated on 2026-02-23
108
Participants Needed
2
Research Sites
245 weeks
Total Duration
On this page
Sponsors
M
Milap Sandhu
Lead Sponsor
B
Baylor Scott and White Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Baylor Scott and White Institute for Rehabilitation
Fort Worth, Texas, United States, 76132
Not Yet Recruiting
Research Team
A
Alexander Barry, MS, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here