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

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT07128901
• Lead Sponsor: Georgia Institute of Technology

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.

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-10-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Subacute to chronic SCI (≥ 3mths post injury)
• Motor-complete (ASIA Impairment Scale classification A/B)
• Injury level T3-T10
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
10 meter walk test (10MWT)	1 year	This will be measured as the participant walks a distance of 10 meters at their self-selected (or comfortable) walking speed. Three 10-meter walk trials will be completed by each participant at each time point. The average of three 10MWT walking speeds will be analyzed and reported. This measure will be recorded in seconds and converted to meters/s with higher values indicating faster speed and lower values indicating slower speeds. Self-selected walking speed is highly correlated with functional ability and dependence.
6 minute walk test (6MWT)	1 year	This is a measurement of endurance and functional ability that assesses the participants ability to walk a distance (meters) over a time period of 6 minutes. It is measured in distance with greater distances indicating improved levels of endurance and functional ability.

Secondary Outcome Measures

Name	Time	Method
Walking economy	1 year	Walking economy is a measure of the energy cost of walking, quantified as the amount of oxygen consumed per kilogram of body weight per meter walked. It reflects the metabolic efficiency of gait, with lower values indicating more efficient walking. This measure will be obtained using the Cosmed K5 indirect calorimetry system during steady-state walking.
Rating of Perceived Exertion	1 year	The Rating of Perceived Exertion is a subjective measure of exertion based on an individual's perception of effort and fatigue during physical activity. The scale ranges from 6 (no exertion) to 20 (maximal exertion).
Total hemoglobin concentration	1 year	Total hemoglobin concentration refers to the amount of hemoglobin present in a given volume of blood. It is an indicator of muscle oxygenation dynamics. This measure will be obtained using continuous wave near-infrared spectroscopy.
User-experience survey	1 year	A custom survey will be administered to assess participant opinion on exoskeleton comfort, ease of use, perceived effort and overall satisfaction.
Neuromuscular activation of specified muscles	1 year	Electromyography sensors will measure the magnitude of muscle activation for the torso throughout the gait cycle. The average magnitude will be computed by averaging the time-series data across gait cycles and computing the average magnitude for the average gait cycle.

Trial Locations

Locations (1)

The Shepherd Center; 🇺🇸 Atlanta, Georgia, United States