NCT06176833 · Milap Sandhu
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
(PROPEL-SCI)
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
Body Weight Supported Treadmill Training
For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.
Primary outcome measures
10 Meter walk test
Time frame: 1-5 days Following Intervention
Used to assess walking speed, time taken to walk 10 meters at fastest pace
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
- Fort Worth, Texas
Collaborators
Baylor Scott and White Health, University of Florida, Congressionally Directed Medical Research Programs
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations