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

RecruitingNAAges 16 Years - 75 YearsAllMilap Sandhu
NCT06176833 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
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
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What it tests

  • Body Weight Supported Treadmill Training
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Where

2 sites
The Shirley Ryan AbilityLab
Chicago, United States
Baylor Scott and White Institute for Rehabilitation
Fort Worth, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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