Spinal Cord InjuriesNCT02566850
Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment
A study testing Ekso in people with Spinal Cord Injuries, run by Ekso Bionics at 1 site in United States.
Trial summary
The purpose of the study is to study the safety and health effects of using the Ekso Bionics powered exoskeleton device in a home setting over an extended period, ranging from 12-42 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Ekso
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 25 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- be an experienced user of the Ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking.
- no more than 2 episodes of balance loss per 1 hour training session that require no more than moderate assistance (support of 26% to 50% of body weight)
- participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures
- be between 18-65 years of age.
- be able to physically fit into the exoskeleton device.
- be able to tolerate upright standing for up to 60 minutes.
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- have sufficient joint range of motion to fit safely within Ekso: Hip flexion contracture ≤ 15o; knee flexion contracture ≤ 10o; ankle dorsiflexion to neutral with no more than 10o of knee flexion.
- have sufficient upper body strength to balance themselves with two arms
- be fluent in English
Who cannot join
- Height below 60 inches or above 76 inches or with physical characteristics incompatible with device and testing procedure.
- Weight above 220 lbs.
- Lower extremity joint contractures that exceed device capacity for safe use.
- Any medical issue that precludes full weight bearing and ambulation (e.g. osteoporosis that prevents safe standing, orthopedic injuries, pain, severe spasticity)
- Skin integrity issues that would prevent wearing the device.
- Cognitive and/or communicative disability inappropriate for testing as determined by Ekso Bionics clinician. Subjects must be able to follow directions well and demonstrate learning capability.
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- Pregnancy (Self-reported)
- Colostomy
- Medical or environmental conditions arising after the start of the study that are deemed unsafe per Ekso Bionics discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigational Study of the Ekso Bionics Powered Exoskeleton for High-Dosage Use by Individuals With Spinal Cord Injury in a Non-Clinical Environment
The purpose of the study is to study the safety and health effects of using the Ekso Bionics powered exoskeleton device in a home setting over an extended period, ranging from 12-42 months.
Read the detailed description
This is a 36 month exploratory Investigational Study compliant with the NSF Human Subjects regulations (45 CFR 690) trialing a new device for the SCI populations to aid in ambulatory function in a home setting. Ekso Bionics will enable up to twelve (12) subjects with SCI to use an Ekso device in their home for a 12-month period. Qualified subjects will help Ekso Bionics determine the practical use of the device in the home environment and will enable Ekso Bionics to gather data to develop a device for use in a home environment. The study will require a trained spotter to be present at all times that the device is being used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the subject.
- Conditions
- Spinal Cord Injuries
- Being tested
- Ekso
- 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.
EksoDevice
Also called Ekso GT
powered lower extremity exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| Ekso Users | Experimental | SCI subjects using Ekso Receives: Device: Ekso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study Participants With Adverse Events
evaluate the safety of a subject walking with a lay spotter in a non-clinical environment
Measured: through study completion for a maximum possible duration of 42 months
Secondary outcomes (10)
International Spinal Cord Injury Data Sets Quality of Life Basic Data Set
Consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied) with a total of 30 points.
Measured: through study completion for a maximum possible duration of 42 months
International Spinal Cord Injury Data Sets Bowel Function Basic Data Set
evaluate the impact on subject's bowel health, subjective questionnaire. Examined time required for defecation in minutes, with shorter time being more favorable
Measured: through study completion for a maximum possible duration of 42 months
International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function
evaluate the impact on subject's bladder health, subjective feedback and written answers collected, no numerical scoring is part of this exam. This data set asks the following questions: Urinary tract impairment unrelated to spinal cord lesion? Awareness of the need to empty the bladder? How does bladder emptying occur? Average number of voluntary bladder emptyings per 24 hours during the last week? Any involuntary urine leakage (urinary incontinence) within the last four weeks? Collecting appliances for urinary incontinence? Any drugs with possible influence on the urinary tract within the last four weeks? Surgical procedures on the urinary tract? Any change in lower urinary tract symptoms within the last year?
Measured: through study completion for a maximum possible duration of 42 months
Spasticity as Tested by the Modified Ashworth Scale
evaluate the impact on subject's spasticity, assessed Elbow Flexors / Extensors, Wrist Flexors / Extensors, Hip Flexors / Extensors, Hip Abductors, Knee Flexors / Extensors, Ankle Plantar Flexors, Ankle Invertors and totaled spasticity for each group (0-5 for right and left) to total between 0 and 70. Higher scores for each muscle group indicate more rigid spasticity, and higher total score indicates more muscle groups involved.
Measured: through study completion for a maximum possible duration of 42 months
International Spinal Cord Injury Data Sets
evaluate the impact on subject's pain. Totaled the following questions with scales from 0-10 for a total score ranging from 0-50. For each question, 0 = "No interference", 10 = "Extreme interference"
"How much has pain changed your ability to take part in recreational and other social activities?" "How much has pain changed the amount of satisfaction or enjoyment you get from family related activities?" "In general, how much has pain interfered with your day to day activities in the last week?" "In general, how much has pain interfered with your overall mood in the past week?" "In general, how much has pain interfered with your ability to get a good night's sleep?"
Measured: through study completion for a maximum possible duration of 42 months
Spinal Cord Independence Measure (SCIM) II
evaluate the impact on subject's functional abilities in 3 domains (self care, respiration and sphicter management, mobility) on a scale from 0-100. Each of the 17 total questions have multiple options that are scored in different values. Some questions range from 0-1 points, while others range from 0-2,0-3, 0-5, 0-8, 0-6,0-10, or 0-15. Higher values for each question, and overall, indicate more independence with the task, while lower scores indicates requiring of more assistance.
Measured: through study completion for a maximum possible duration of 42 months
Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam)
evaluate the impact on subject's muscle strength. Total upper and lower extremity motor scores (0-5 for right and left) for each of the following muscle groups for a total of 120 points. For each muscle group, 0 is defined as no palpable contraction, while 5 is full strength.
Shoulder Flexion Shoulder Extension Elbow Flexion Elbow Extension Wrist Extension Gross Grip Strength Hip Flexion Hip Extension Hip Abduction Knee Extension Ankle Dorsiflexion Ankle Plantar Flexion
Measured: through study completion for a maximum possible duration of 42 months
Borg Perceived Rate of Exertion
evaluate the impact on subject's effort while walking. Measure taken for each session on scale from 6-20. Average was taken from each participant over their total number of sessions. Higher scores on the Borg indicates the participants feels like they are working harder.
Measured: through study completion for a maximum possible duration of 42 months
Length of Participation in Study
Number of months that a participant utilized the Ekso in their home with a lay spotter
Measured: through study completion for a maximum possible duration of 42 months
Secondary Health Conditions
Frequency of secondary health complications as reported by participants
Measured: Through study completion for a maximum possible duration of 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJan 2014
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Why it stopped: Preliminary results acceptable, investigators moved attention to different project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekso Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566850
- Sponsor's protocol ID
- 13098
- Status last verified
- Sep 2023
- First submitted
- 29 Sep 2015
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Study of the Ekso Bionics Powered Exoskeleton for High-Dosage Use by Individuals With Spinal Cord Injury in a Non-Clinical Environment
- ClinicalTrials.gov ID
- NCT02566850
- Acronym / sponsor ID
- 13098
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary results acceptable, investigators moved attention to different project
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ekso BionicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 28 Sep 2023
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 the study is to study the safety and health effects of using the Ekso Bionics powered exoskeleton device in a home setting over an extended period, ranging from 12-42 months.
Detailed description
This is a 36 month exploratory Investigational Study compliant with the NSF Human Subjects regulations (45 CFR 690) trialing a new device for the SCI populations to aid in ambulatory function in a home setting. Ekso Bionics will enable up to twelve (12) subjects with SCI to use an Ekso device in their home for a 12-month period. Qualified subjects will help Ekso Bionics determine the practical use of the device in the home environment and will enable Ekso Bionics to gather data to develop a device for use in a home environment. The study will require a trained spotter to be present at all times that the device is being used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the subject.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ekso Users | Experimental | Device: EksoSCI subjects using Ekso |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be an experienced user of the Ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking.
- no more than 2 episodes of balance loss per 1 hour training session that require no more than moderate assistance (support of 26% to 50% of body weight)
- participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures
- be between 18-65 years of age.
- be able to physically fit into the exoskeleton device.
Key exclusion criteria (9 listed)
- Height below 60 inches or above 76 inches or with physical characteristics incompatible with device and testing procedure.
- Weight above 220 lbs.
- Lower extremity joint contractures that exceed device capacity for safe use.
- Any medical issue that precludes full weight bearing and ambulation (e.g. osteoporosis that prevents safe standing, orthopedic injuries, pain, severe spasticity)
- Skin integrity 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 |
|---|---|---|
| EksoAlso: Ekso GTpowered lower extremity exoskeleton | Device | Ekso Users |
Primary outcome
Number of Study Participants With Adverse Events
Time frame: through study completion for a maximum possible duration of 42 months
evaluate the safety of a subject walking with a lay spotter in a non-clinical environment
10 secondary outcomes
International Spinal Cord Injury Data Sets Quality of Life Basic Data Set
Time frame: through study completion for a maximum possible duration of 42 months
International Spinal Cord Injury Data Sets Bowel Function Basic Data Set
Time frame: through study completion for a maximum possible duration of 42 months
International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function
Time frame: through study completion for a maximum possible duration of 42 months
Spasticity as Tested by the Modified Ashworth Scale
Time frame: through study completion for a maximum possible duration of 42 months
International Spinal Cord Injury Data Sets
Time frame: through study completion for a maximum possible duration of 42 months
Spinal Cord Independence Measure (SCIM) II
Time frame: through study completion for a maximum possible duration of 42 months
Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam)
Time frame: through study completion for a maximum possible duration of 42 months
Borg Perceived Rate of Exertion
Time frame: through study completion for a maximum possible duration of 42 months
Length of Participation in Study
Time frame: through study completion for a maximum possible duration of 42 months
Secondary Health Conditions
Time frame: Through study completion for a maximum possible duration of 42 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 in people with Spinal Cord Injuries, run by Ekso Bionics 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 28 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Study Participants With Adverse Events (time frame: through study completion for a maximum possible duration of 42 months). 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 28 Sep 2023.