Spinal Cord InjuriesNCT07128901
Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury
A study testing Ekso Indego Therapy and Wandercraft Atalante X in people with Spinal Cord Injuries, run by Georgia Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Ekso Indego Therapy and Wandercraft Atalante X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to 19 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacute to chronic SCI (≥ 3mths post injury)
- Motor-complete (ASIA Impairment Scale classification A/B)
- Injury level T3-T12
- Age 18-70 yrs
- Height between 5'1" and 6'1"
- Weight <200 lbs (90kg)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Analysis of Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury
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.
Read the 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
- Being tested
- Ekso Indego Therapy, Wandercraft Atalante X
- Keywords
- lower limb exoskeleton
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ekso Indego TherapyDevice
User-balancing lower Limb exoskeleton
Wandercraft Atalante XDevice
Self-balancing lower limb exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| Self-balancing lower limb exoskeleton | Experimental | Participants will use the self-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session. Receives: Device: Wandercraft Atalante X |
| User-balancing lower limb exoskeleton | Experimental | Participants will use the user-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session. Receives: Device: Ekso Indego Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start10 Dec 2025
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA
- Responsible party
- Principal investigator, Maegan Tucker, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128901
- Sponsor's protocol ID
- 2331046-1
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07128901
- Acronym / sponsor ID
- 2331046-1
- Conditions
- Spinal Cord Injuries
- Keywords
- lower limb exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-balancing lower limb exoskeleton | Experimental | Device: Wandercraft Atalante XParticipants will use the self-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session. |
| User-balancing lower limb exoskeleton | Experimental | Device: Ekso Indego TherapyParticipants will use the user-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subacute to chronic SCI (≥ 3mths post injury)
- Motor-complete (ASIA Impairment Scale classification A/B)
- Injury level T3-T12
- Age 18-70 yrs
- Height between 5'1" and 6'1"
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ekso Indego TherapyUser-balancing lower Limb exoskeleton | Device | User-balancing lower limb exoskeleton |
| Wandercraft Atalante XSelf-balancing lower limb exoskeleton | Device | Self-balancing lower limb exoskeleton |
Primary outcome
10 meter walk test (10MWT)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Neuromuscular activation of specified muscles
Time frame: 1 year
Walking economy
Time frame: 1 year
Rating of Perceived Exertion
Time frame: 1 year
Total hemoglobin concentration
Time frame: 1 year
User-experience survey
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ekso Indego Therapy and Wandercraft Atalante X in people with Spinal Cord Injuries, run by Georgia Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (10MWT) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.