Spinal Cord InjuriesNCT04250688
Robotic Exoskeleton With Functional Electrical Stimulation in Acute Spinal Cord Injury
A study testing Ekso Training with FES in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab.
Trial summary
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) in persons affected by spinal cord injury; designated AIS classification A, B, C, or D. 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 Training with FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2023
- 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
- Medical clearance from attending inpatient physician
- Have an upper motor neuron spinal cord injury classified as ASIA A, B or C or D between C7-T11Subacute injury <6 months at completion of study
- Be between 18-70 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 within normal functional limits for ambulation.
- Have sufficient upper body strength to balance themself using the walker while wearing the exoskeleton.
Who cannot join
- Cervical level spinal cord injury above C6 or T12 and below
- Weight above 220 pounds
- Femur length above 47 cm or below 36 cm
- Joint contractures at the hip, knee, or ankle that limit normal range of motion (ROM) during ambulation;
- Cognitive and/or communication disability (e.g. due to brain injury);
- History of significant problems with skin break down or current skin break down that would prevent wearing the device;
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- Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
- History of severe osteoporosis or high risk of fractures. Medical clearance will be obtained for patients who are at risk of osteoporosis or fractures;
- Pregnancy;
- Inability to sign consent form indicating insufficient hand dexterity to utilize an assistive device.
- Cardiac Pacemaker;
- Metal implants in the areas of stimulation.
About this study
Official title: Effect of a Robotic Exoskeleton With Functional Electrical Stimulation on Neural Recovery in Individuals With Acute Spinal Cord Injury
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) in persons affected by spinal cord injury; designated AIS classification A, B, C, or D. Traditionally, a person with an American Spinal Injury Association Impairment Scale (AIS) "A" injury, walking training is not performed. Even with AIS B, C and D injuries, although walking training may be appropriate, a person may not walk as much as needed to see an improvement due to environmental and staff limitations. The Ekso is a tool to give walking training to patients. The investigators aim to see if utilizing these technologies will affect recovery; specifically in sensation and muscle activity below the level of the injury as well as the ability to walk.
The Ekso is a wearable, battery- operated exoskeleton that assists with walking. The Ekso has motors at the hip and knee joints to provide assistance that may be needed with walking. All motion is initiated either through body weight shifts or the use of an external controller. The Ekso robotic exoskeleton has been approved by the Food and Drug Administration as a powered exercise device for rehabilitative purposes such as this study. Currently, the Ekso is approved for people with spinal cord injuries from T4-L5 given bilateral arm strength of 4/5. With injuries from C7-T3, individuals must have AIS classification of D with bilateral arm strength of 4/5. For this study, it is possible that Ekso GT will be used outside of the current FDA approval if the injury level is C7-T3 and the person is classified as an AIS A, B or C injury level. Functional electrical stimulation (FES) will be used in conjunction with the robotic exoskeleton. FES involves using surface electrodes placed on the skin like a sticker over key leg muscles that will be stimulated in the normal walking pattern as a person walks in the device.
Read the detailed description
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) on neural recovery in individuals with acute spinal cord injury with American Spinal Injury Association Impairment Scale (AIS) neurologic classification A, B, C or D.
Specifically, individuals with acute SCI in the inpatient rehabilitation setting improve their AIS score after mobility training with the Ekso-FES compared to a control intervention period?
In addition, the investigators will analyze the influence of training performed early or later in acute rehabilitation phase on muscle properties, neural recovery and function.
This is an investigational clinical study trialing the efficacy of the Ekso device with FES in the acute SCI population. Participants with a diagnosis of spinal cord injury classified as AIS A, B, C or D will be included. Up to ten participants will be recruited to participate in this study. This number was arbitrarily chosen as this is an investigational study and there is no previous data on the Ekso device to specifically select subject number based on a power analysis. Participants will be recruited from inpatient units at The Shirley Ryan AbilityLab. Following screening, all subjects will be required to receive medical clearance from their attending inpatient physician.
Subjects will be randomized to which order they receive the Ekso intervention (A) and control (B) period (A then B or B then A). The device will be used in the lab and there will be no charge associated with use of the Ekso device.
All participants involved in the investigational study/training will be screened according to general inclusion/exclusion criteria after obtaining informed consent and before using the Ekso device.
Screening will include:
- Range of Motion (ROM): Range of motion of the joints of the upper and lower extremities will be measured using a goniometer
- Muscle strength testing: upper and lower extremity manual muscle testing to determine qualification for study inclusion.
- Modified Ashworth Scale (MAS): The Modified Ashworth Scale is a 6 point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.
- Upper and lower leg length and hip measurements will be performed to determine safe fit in the exoskeleton device.
- Conditions
- Spinal Cord Injuries
- Being tested
- Ekso Training with FES
- Keywords
- exoskeleton, ambulation, robotics, Functional electrical stimulation, acute spinal cord injuries
- 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 Training with FESDevice
| Study group | Role | What they receive |
|---|---|---|
| Esko Bionics Suit + Functional Electrical Stimulation | Experimental | Not described Receives: Device: Ekso Training with FES |
| Control | No intervention | Not described |
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)
The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The minimum score is zero feet walked, there is no maximum score and the participant will be scored by how far they can walk in 6 minutes. The farther they walk, the better the score. 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.
Measured: [Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6.]
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: Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6
Secondary outcomes (2)
Magnetic resonance imaging lower extremity muscle volume
Manual segmentation of lower extremity musculature, for the purpose of muscle architectural quantification. Muscle's percent change was being compared
Measured: Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6
Magnetic resonance imaging lower extremity fat infiltration
Manual segmentation of lower extremity fat infiltration, for the purpose of muscle architectural quantification. Muscle's percent change was being compared
Measured: Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250688
- Sponsor's protocol ID
- STU00202078
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Robotic Exoskeleton With Functional Electrical Stimulation on Neural Recovery in Individuals With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04250688
- Acronym / sponsor ID
- STU00202078
- Conditions
- Spinal Cord Injuries
- Keywords
- exoskeleton, ambulation, robotics, Functional electrical stimulation, acute spinal cord injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Jan 2020 (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 examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) in persons affected by spinal cord injury; designated AIS classification A, B, C, or D. Traditionally, a person with an American Spinal Injury Association Impairment Scale (AIS) "A" injury, walking training is not performed. Even with AIS B, C and D injuries, although walking training may be appropriate, a person may not walk as much as needed to see an improvement due to environmental and staff limitations. The Ekso is a tool to give walking training to patients. The investigators aim to see if utilizing these technologies will affect recovery; specifically in sensation and muscle activity below the level of the injury as well as the ability to walk.
The Ekso is a wearable, battery- operated exoskeleton that assists with walking. The Ekso has motors at the hip and knee joints to provide assistance that may be needed with walking. All motion is initiated either through body weight shifts or the use of an external controller. The Ekso robotic exoskeleton has been approved by the Food and Drug Administration as a powered exercise device for rehabilitative purposes such as this study. Currently, the Ekso is approved for people with spinal cord injuries from T4-L5 given bilateral arm strength of 4/5. With injuries from C7-T3, individuals must have AIS classification of D with bilateral arm strength of 4/5. For this study, it is possible that Ekso GT will be used outside of the current FDA approval if the injury level is C7-T3 and the person is classified as an AIS A, B or C injury level. Functional electrical stimulation (FES) will be used in conjunction with the robotic exoskeleton. FES involves using surface electrodes placed on the skin like a sticker over key leg muscles that will be stimulated in the normal walking pattern as a person walks in the device.
Detailed description
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation (FES) on neural recovery in individuals with acute spinal cord injury with American Spinal Injury Association Impairment Scale (AIS) neurologic classification A, B, C or D.
Specifically, individuals with acute SCI in the inpatient rehabilitation setting improve their AIS score after mobility training with the Ekso-FES compared to a control intervention period?
In addition, the investigators will analyze the influence of training performed early or later in acute rehabilitation phase on muscle properties, neural recovery and function.
This is an investigational clinical study trialing the efficacy of the Ekso device with FES in the acute SCI population. Participants with a diagnosis of spinal cord injury classified as AIS A, B, C or D will be included. Up to ten participants will be recruited to participate in this study. This number was arbitrarily chosen as this is an investigational study and there is no previous data on the Ekso device to specifically select subject number based on a power analysis. Participants will be recruited from inpatient units at The Shirley Ryan AbilityLab. Following screening, all subjects will be required to receive medical clearance from their attending inpatient physician.
Subjects will be randomized to which order they receive the Ekso intervention (A) and control (B) period (A then B or B then A). The device will be used in the lab and there will be no charge associated with use of the Ekso device.
All participants involved in the investigational study/training will be screened according to general inclusion/exclusion criteria after obtaining informed consent and before using the Ekso device.
Screening will include:
- Range of Motion (ROM): Range of motion of the joints of the upper and lower extremities will be measured using a goniometer
- Muscle strength testing: upper and lower extremity manual muscle testing to determine qualification for study inclusion.
- Modified Ashworth Scale (MAS): The Modified Ashworth Scale is a 6 point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.
- Upper and lower leg length and hip measurements will be performed to determine safe fit in the exoskeleton device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esko Bionics Suit + Functional Electrical Stimulation | Experimental | Device: Ekso Training with FES |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Medical clearance from attending inpatient physician
- Have an upper motor neuron spinal cord injury classified as ASIA A, B or C or D between C7-T11Subacute injury <6 months at completion of study
- Be between 18-70 years of age.
- Be able to physically fit into the exoskeletal device.
- Be able to tolerate upright standing for a minimum of 30 minutes.
Key exclusion criteria (12 listed)
- Cervical level spinal cord injury above C6 or T12 and below
- Weight above 220 pounds
- Femur length above 47 cm or below 36 cm
- Joint contractures at the hip, knee, or ankle that limit normal range of motion (ROM) during ambulation;
- Cognitive and/or communication disability (e.g. due to brain injury);
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 Training with FES | Device | Esko Bionics Suit + Functional Electrical Stimulation |
Primary outcome
Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE)
Time frame: [Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6.]
The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The minimum score is zero feet walked, there is no maximum score and the participant will be scored by how far they can walk in 6 minutes. The farther they walk, the better the score. 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.
Change in 10 meter walk test from baseline in gait speed
Time frame: Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6
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."
2 secondary outcomes
Magnetic resonance imaging lower extremity muscle volume
Time frame: Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6
Magnetic resonance imaging lower extremity fat infiltration
Time frame: Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
Questions about this trial
What is this clinical trial studying?
A study testing Ekso Training with FES in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab.
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 7 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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) (time frame: [Time Frame: Testing Day 1 - 3 and follow up testing Week 3 and Week 6.]). 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 7 Mar 2023; AzTrials last refreshed its copy on 2 Nov 2026.