NCT07128901

Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Georgia Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Although Lower Limb Exoskeleton technology holds promise for improving mobility and independence in people with Spinal Cord Injury, limited research has examined the physiological and psychological effects of walking with self-balancing lower limb exoskeleton technology compared to systems that require user-operated assistive aids. Moreover, no studies to date have directly compared the short- and long-term outcomes of two lower limb exoskeleton technology types: (1) self-balancing and (2) user-balancing. To address this gap, this study will conduct a head-to-head comparison of self-balancing and user-balancing lower limb exoskeleton technology in individuals with motor-complete (ASIA Impairment Scale Classification \[AIS\] A/B) Spinal Cord Injury-a population that remains underrepresented in rehabilitation robotics research despite advances in the field. Study participants will complete 5 walking sessions and 2 test sessions with two different exoskeleton devices in a randomized order. During each test session, data will be collected using motion sensors, portable metabolic monitors, and muscle sensors.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Ekso Indego Therapy	User-balancing lower Limb exoskeleton
DEVICE	Wandercraft Atalante X	Self-balancing lower limb exoskeleton

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-08-19
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study