An interventional study of Ekso Indego Therapy and Wandercraft Atalante X in Spinal Cord Injuries, sponsored by Georgia Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Georgia Institute of Technology · Not applicable, Interventional, and Basic science
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 6 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Georgia Institute of Technology is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
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Exclusion Criteria:
Participants will use the self-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.
Device: Wandercraft Atalante X
Participants will use the user-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.
Device: Ekso Indego Therapy
User-balancing lower Limb exoskeleton
Self-balancing lower limb exoskeleton
10 meter walk test (10MWT)
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.
Time frame: 1 year
6 minute walk test (6MWT)
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.
Time frame: 1 year
Neuromuscular activation of specified muscles
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.
Time frame: 1 year
Walking economy
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.
Time frame: 1 year
Rating of Perceived Exertion
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).
Time frame: 1 year
Total hemoglobin concentration
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.
Time frame: 1 year
User-experience survey
A custom survey will be administered to assess participant opinion on exoskeleton comfort, ease of use, perceived effort and overall satisfaction.
Time frame: 1 year
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Georgia Institute of Technology