Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal … (NCT06176833) | Clinical Trial Compass
RecruitingNot Applicable
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
United States108 participantsStarted 2024-03-21
Plain-language 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.
Who can participate
Age range
16 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.