Spinal Cord Injuries or Similar Neurological WeaknessEKSONCT01701388
EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI)
A study testing Ekso exoskeleton in people with Spinal Cord Injuries or Similar Neurological Weakness, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries or Similar Neurological Weakness
- What is being tested?
- Ekso exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- have a spinal cord injury SCI between C7-S1.
- be between 18-65 years of age.
- be able to physically fit into the exoskeletal device.
- be able to tolerate upright standing for a minimum of 30 minutes.
- have joint range of motion (ROM) within normal functional limits for ambulation.
- have sufficient upper body strength to balance themselves using the walker while wearing the exoskeleton.
- have a different neurological weakness than SCI but fit the other inclusion criteria above
Who cannot join
- Height below 62 inches or above 74 inches
- Weight above 220 lbs.
- Joint contractures of any extremity that limits normal ROM during ambulation with assistive devices.
- Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity)
- Skin issues that would prevent wearing the device.
- Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions well and demonstrate learning capability.
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- Significant Osteoporosis: Osteoporosis will be graded based on the T score that indicates a person's bone mineral content and is graded as follows: (14)
- T +1: Normal bone density:
- T -1 to -2.5: Low bone density of osteopenia
- T -2.5 to -3.0: osteoporosis
- T <-3.0: Severe osteoporosis
- If the patient has severe osteoporosis and a T score of <-3, participation in the study will be considered based upon their physicians recommendation and overall evaluation of the patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: Investigational Study of the Ekso Powered Exoskeleton for Ambulation in Individuals With Spinal Cord Injury (or Similar Neurological Weakness)
This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows:
- Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance while wearing the device as noted by subject's ability to safely achieve standing balance for 30 sec without loss of balance.
- Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to safely ambulate 10 meters to be assessed using the 10 meter walk test.
- Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in both static and dynamic activities as determined by a trained physical therapist.
- Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with training of the device as noted by subjective questionnaires that will be assessed following each training session.
Read the detailed description
This is an investigational clinical study trialing the safety and efficacy of the Esko device in the SCI population. Participants with a variety of spinal cord injury diagnoses (e.g. motor complete/incomplete, paraplegia/ tetraplegia) or diagnoses presenting with similar neurological weakness will be included to best determine the criteria for using the Ekso device within this population. The Ekso is an anthropomorphic mobile exoskeleton that is intended for spinal cord injury rehabilitation and mobility. The device is used to drive the patient's lower extremity joints through a desired trajectory in order to obtain a user specified motion.
The device is electrically powered by two motors at the knee and hip joints of either leg of the user. The flexion and extension directions at the hip and knee are only actuated degrees of freedom on the device. The device is equipped with mechanical hard stops at the limits of healthy subject ranges of motion to prevent powering the joint of the user to a position that the joint cannot reach. The device operates using a number of sensors. Some of these sensors are dedicated to maintaining proper function of the mechanical system and some are devoted to determining the user intent while using the device. The user focused sensors are foot pressure sensors at the heel and toe of both feet to determine the forces between the user and the ground at those locations.
The control code in the device behaves by creating an internal estimate of the subject's current position and then coordinating the motion of the four actuated degrees of freedom to take the desired motion. The desired motion is specified through an attached user interface that can be used by the patient or a therapist. The device can currently stand from a seated position, walk, and turn and sit down. In actual operation the device is triggered by one of two modes. The first mode is used early in training where the therapist manually triggers the steps of the user using the graphical interface; for advanced users, the machine interprets their motions to determine when steps are desired and the therapist is only responsible for starting and stopping the motion.
Complete and incomplete SCI patients as well as patients with similar neurological weakness will be recruited from inpatient, day rehab and outpatient clinics. Participants will be scheduled from 1-40 sessions. The amount of sessions provided will be dependent upon compatibility with device, ability to tolerate device use and ability to safely ambulate using the device. A participant will continue with each phase of the study as deemed appropriate by research staff:
- A.Phase 1 (1-3 sessions): To determine if participant is compatible with device use. If participant is not compatible with device the study will stop here. If participant is compatible with device, subject will move into phase 2.
- B.Phase 2 (4-10 sessions): Assessment and training of participant with device to determine safety and efficacy of subject with device. If subject is unsafe with device or does not tolerate device well then the study will stop here. If participant is safe, comfortable and efficient with device, participant will move into phase 3.
- C.Phase 3 (11-40 sessions): Continued training with participant to determine functional ability of patient to use device within a lab or clinical environment.
All testing and training sessions will be under supervision of a licensed physical therapist. Manual assistance or cueing will be provided as necessary for safety and balance. Vital signs will be monitored before and after physical exertion. All subjects will be permitted to stop physical activity or rest at any time during the study. Adverse events will be recorded.
We anticipate this study will help to determine if the Ekso device is a feasible option to initiate ambulation in the motor complete SCI population, motor incomplete SCI population and other similar diagnostic populations unable to ambulate over ground. We do not foresee any potential pitfalls.
- Being tested
- Ekso exoskeleton
- Keywords
- Ekso, Exoskeleton, Spinal Cord Injury, Motor Complete Incomplete
- 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 exoskeletonDevice
Also called Ekso by Eksobionics
The participants will receive 1 - 40 training sessions. The sessions will be 1 hour of device use including balance training, gait training and sit to and from stand training with rolling walker and/ or forearm crutches.
| Study group | Role | What they receive |
|---|---|---|
| Ekso Safety and Efficacy | Experimental | Observational study on the first time use of a robotic exoskeleton. Receives: Device: Ekso exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake
The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points. The maximal oxygen consumption (VO2 MAX) data is collected during the test every 10 seconds
Measured: Testing Day 1 - 3 and follow up testing Week 6 and Week 12.
Change in 10 meter walk test from baseline in gait speed
Measure the time in second for and individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: " Please walk this distance as fast as you safely can when I say go."
Measured: Testing Day 1 - 3 and follow up testing Week 6 and Week 12
Secondary outcomes (3)
Ratio of number of steps/walking time
The data will be collected from the Ekso statistics mode [data provided by the machine]
Measured: Testing Day 1 - 3 and follow up testing Week 6 and Week 12.
2 Minute Walk Test
Individual walks for 2 minutes and the distance is measured, start timing when the individual is instructed to "Go,"stop timing at 2 minutes, assistive devices can be used and documented from test to test, if physical assistance and/or tethering is required it will be recorded as well. The test should be performed at the fastest safest speed possible.
Measured: Testing Day 1 and follow up testing Week 6 and Week 12
Walk time to stand time ratio on a particular assistive device
The data will be collected from the statistics section of the Ekso. As patients progress from a rolling walker assistive device to the forearm crutches the ratio will be collected and compared to the initial and then final sessions with that particular device.
Measured: Testing Day 1 and follow up testing Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startMay 2012
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries or Similar Neurological WeaknessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PhD, Principal investigator, RIC/Northwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701388
- Sponsor's protocol ID
- NU59727
- Acronym
- EKSO
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2012
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Study of the Ekso Powered Exoskeleton for Ambulation in Individuals With Spinal Cord Injury (or Similar Neurological Weakness)
- ClinicalTrials.gov ID
- NCT01701388
- Acronym / sponsor ID
- EKSO / NU59727
- Keywords
- Ekso, Exoskeleton, Spinal Cord Injury, Motor Complete Incomplete
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- May 2012 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2012 (estimated)
- 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.
This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows:
- Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance while wearing the device as noted by subject's ability to safely achieve standing balance for 30 sec without loss of balance.
- Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to safely ambulate 10 meters to be assessed using the 10 meter walk test.
- Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in both static and dynamic activities as determined by a trained physical therapist.
- Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with training of the device as noted by subjective questionnaires that will be assessed following each training session.
Detailed description
This is an investigational clinical study trialing the safety and efficacy of the Esko device in the SCI population. Participants with a variety of spinal cord injury diagnoses (e.g. motor complete/incomplete, paraplegia/ tetraplegia) or diagnoses presenting with similar neurological weakness will be included to best determine the criteria for using the Ekso device within this population. The Ekso is an anthropomorphic mobile exoskeleton that is intended for spinal cord injury rehabilitation and mobility. The device is used to drive the patient's lower extremity joints through a desired trajectory in order to obtain a user specified motion.
The device is electrically powered by two motors at the knee and hip joints of either leg of the user. The flexion and extension directions at the hip and knee are only actuated degrees of freedom on the device. The device is equipped with mechanical hard stops at the limits of healthy subject ranges of motion to prevent powering the joint of the user to a position that the joint cannot reach. The device operates using a number of sensors. Some of these sensors are dedicated to maintaining proper function of the mechanical system and some are devoted to determining the user intent while using the device. The user focused sensors are foot pressure sensors at the heel and toe of both feet to determine the forces between the user and the ground at those locations.
The control code in the device behaves by creating an internal estimate of the subject's current position and then coordinating the motion of the four actuated degrees of freedom to take the desired motion. The desired motion is specified through an attached user interface that can be used by the patient or a therapist. The device can currently stand from a seated position, walk, and turn and sit down. In actual operation the device is triggered by one of two modes. The first mode is used early in training where the therapist manually triggers the steps of the user using the graphical interface; for advanced users, the machine interprets their motions to determine when steps are desired and the therapist is only responsible for starting and stopping the motion.
Complete and incomplete SCI patients as well as patients with similar neurological weakness will be recruited from inpatient, day rehab and outpatient clinics. Participants will be scheduled from 1-40 sessions. The amount of sessions provided will be dependent upon compatibility with device, ability to tolerate device use and ability to safely ambulate using the device. A participant will continue with each phase of the study as deemed appropriate by research staff:
- A.Phase 1 (1-3 sessions): To determine if participant is compatible with device use. If participant is not compatible with device the study will stop here. If participant is compatible with device, subject will move into phase 2.
- B.Phase 2 (4-10 sessions): Assessment and training of participant with device to determine safety and efficacy of subject with device. If subject is unsafe with device or does not tolerate device well then the study will stop here. If participant is safe, comfortable and efficient with device, participant will move into phase 3.
- C.Phase 3 (11-40 sessions): Continued training with participant to determine functional ability of patient to use device within a lab or clinical environment.
All testing and training sessions will be under supervision of a licensed physical therapist. Manual assistance or cueing will be provided as necessary for safety and balance. Vital signs will be monitored before and after physical exertion. All subjects will be permitted to stop physical activity or rest at any time during the study. Adverse events will be recorded.
We anticipate this study will help to determine if the Ekso device is a feasible option to initiate ambulation in the motor complete SCI population, motor incomplete SCI population and other similar diagnostic populations unable to ambulate over ground. We do not foresee any potential pitfalls.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ekso Safety and Efficacy | Experimental | Device: Ekso exoskeletonObservational study on the first time use of a robotic exoskeleton. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- have a spinal cord injury SCI between C7-S1.
- be between 18-65 years of age.
- be able to physically fit into the exoskeletal device.
- be able to tolerate upright standing for a minimum of 30 minutes.
- have joint range of motion (ROM) within normal functional limits for ambulation.
Key exclusion criteria (12 listed)
- Height below 62 inches or above 74 inches
- Weight above 220 lbs.
- Joint contractures of any extremity that limits normal ROM during ambulation with assistive devices.
- Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity)
- Skin issues that would prevent wearing the device.
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 exoskeletonAlso: Ekso by EksobionicsThe participants will receive 1 - 40 training sessions. The sessions will be 1 hour of device use including balance training, gait training and sit to and from stand training with rolling walker and/ or forearm crutches. | Device | Ekso Safety and Efficacy |
Primary outcome
Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake
Time frame: Testing Day 1 - 3 and follow up testing Week 6 and Week 12.
The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points. The maximal oxygen consumption (VO2 MAX) data is collected during the test every 10 seconds
Change in 10 meter walk test from baseline in gait speed
Time frame: Testing Day 1 - 3 and follow up testing Week 6 and Week 12
Measure the time in second for and individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: " Please walk this distance as fast as you safely can when I say go."
3 secondary outcomes
Ratio of number of steps/walking time
Time frame: Testing Day 1 - 3 and follow up testing Week 6 and Week 12.
2 Minute Walk Test
Time frame: Testing Day 1 and follow up testing Week 6 and Week 12
Walk time to stand time ratio on a particular assistive device
Time frame: Testing Day 1 and follow up testing Week 6 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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.
Arun Jayaraman, PhD principal investigator
RIC/Northwestern
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 exoskeleton in people with Spinal Cord Injuries or Similar Neurological Weakness, run by Shirley Ryan AbilityLab 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake (time frame: Testing Day 1 - 3 and follow up testing Week 6 and Week 12.). 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 22 Oct 2026.