Comparison of two lower-limb exoskeleton types for people with non-ambulatory spinal cord injury

A Comparative Analysis of Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury

This tests two wearable lower-limb exoskeletons—a self‑balancing device and a device that uses walking aids—to see which better supports people with motor‑complete spinal cord injury during walking.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Georgia Institute of Technology (other)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT07128901 on ClinicalTrials.gov

What this trial studies

This head-to-head, randomized crossover comparison enrolls people with motor‑complete (AIS A/B) spinal cord injury and has each participant complete five walking practice sessions and two formal test sessions with two different exoskeletons. Outcomes include physiological measures (motion sensors, portable metabolic monitors, muscle sensors) and user experience collected during and after walking. The study focuses on individuals with T3–T11 injuries who are subacute to chronic (≥3 months) and meet specific height, weight, and strength criteria. Data will compare short‑ and longer‑term responses to self‑balancing versus user‑balancing exoskeleton designs to inform device selection and rehabilitation approaches.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 years old with motor‑complete (AIS A/B) thoracic (T3–T11) spinal cord injury at least three months old who meet the study's height, weight, hip width, standing tolerance, and upper‑limb strength requirements and are enrolled in the Shepherd Center Beyond Therapy program.

Not a fit: Patients with active skin wounds, significant joint contractures, uncontrolled spasticity or autonomic dysreflexia, recent fractures, active DVT or HO, pregnancy, cognitive impairment affecting safe participation, or who exceed the study's size/strength limits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the trial could identify which exoskeleton type lowers energy cost and improves comfort and safety, guiding device choice and therapy plans for people with motor‑complete SCI.

How similar studies have performed: Prior work shows lower‑limb exoskeletons can enable upright walking and improve some physiological outcomes, but direct head‑to‑head comparisons of self‑balancing versus user‑balancing devices are novel and limited.

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 follow verbal instructions or making it unsafe to participate in assessments.
* Any reason the principal investigator feels the potential participant may not be safe to participate in the study

Where this trial is running

Atlanta, Georgia

• The Shepherd Center — Atlanta, Georgia, United States (RECRUITING)

Study contacts

• Study coordinator: Maegan Tucker, PhD

Conditions: Spinal Cord Injuries, lower limb exoskeleton