Status:
RECRUITING
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
Lead Sponsor:
Milap Sandhu
Collaborating Sponsors:
Baylor Scott and White Health
University of Florida
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
16-75 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06176833
Start Date
March 21 2024
End Date
December 1 2028
Last Update
April 8 2024
Active Locations (2)
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1
The Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
2
Baylor Scott and White Institute for Rehabilitation
Fort Worth, Texas, United States, 76132