Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT06176833
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT06176833
Study Brief:
Protocol Section:
NCT06176833