NCT07128901 Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury
| NCT ID | NCT07128901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgia Institute of Technology |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-12-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to compare two types of wearable lower-extremity exoskeletons -a self-balancing device lower-extremity exoskeleton and a user-balancing device lower-extremity exoskeleton-to better understand their effects on the physiological responses to walking and the user experience in people with spinal cord injury.
Eligibility Criteria
Inclusion Criteria: * Subacute to chronic SCI (≥ 3mths post injury) * Motor-complete (ASIA Impairment Scale classification A/B) * Injury level T3-T11 * Age 18-70 yrs * Height between 5'1" and 6'1" * Weight \<200 lbs (90kg) * Seated hip width \< 42cm * Standing tolerance \> 15mins * Have sufficient upper limb strength to use a platform rolling walker, rolling walker, or forearm crutches * Currently medically cleared and enrolled in the Shepherd Center Beyond Therapy program * Medically cleared for weight-bearing activities * Able to follow directions to safely participate in assessments Exclusion Criteria: * Existing skin lesions or wounds * Hip or knee contracture \> 10 degrees or ankle contracture \> 5 degrees * Severe or uncontrolled spasticity * Non-healing fractures * Uncontrolled autonomic dysreflexia * Heart or peripheral vascular condition * Pregnancy * Active heterotopic ossification * Active deep vein thrombosis * Cognitive deficits that make it difficult for participants to f