Multiple SclerosisNCT04000373
Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
A study testing Ekso GT™ exoskeleton in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigator plans to test the use of the Ekso Bionics® Gait Training (Ekso GT™) exoskeleton for gait training in MS patients. The device will solely be used in the clinic under direct supervision from a physical therapist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic
- What is being tested?
- Ekso GT™ exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 9 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS per 2017 revised McDonald criteria
- EDSS score 5.5-7.5 (moderate to severe walking disability)
- Cleared for gait training with the study device by the study treating physician
- Device-Specific Criteria
- Involved in a standing program or must be able to tolerate at least 15 min upright without signs or symptoms of orthostatic hypotension
- Weigh 220 pounds (100kg) or less
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- Be able to fit into the Ekso device:
- Between approximately 5'0" and 6'4" tall (really depends on leg measurements)
- Sufficient diaphragmatic strength such that respiration is not compromised with exercise
- Assessed by physical therapy:
- Standing hip width of approximately 18" or less
- Have near normal range of motion(ROM) in hips, knees and ankles
- Sufficient upper extremity strength to use a front wheeled walker by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction and flexion/extension of 4/5 OR as discussed during demo, 2 normally functioning limbs such as in hemiplegia)
Who cannot join
- • MS exacerbation, severe acute comorbidity or surgery less than 90 days prior to enrollment
- Diagnosed with osteoporosis or history of long bone fractures since diagnosis
- Safety concern due to neurologic impairments (e.g. upper extremity weakness, visual loss) or comorbidities (e.g. cardiac, respiratory)
- Other neurologic or non-neurologic condition interfering with walking
- < 1 month since previous intensive gait training regimen or initiation of treatment that can affect walking (e.g. medication for spasticity)
- Planned change in medications that may affect walking during the study period
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- Uncontrolled or severe orthostatic hypotension that limits standing tolerance
- Active heterotrophic ossification (HO), hip dysplasia, or uncontrolled hip/knee axis abnormalities
- Score <22 on the Mini-Mental State Examination or deemed to have cognitive impairment precluding safe training with the device during the screening and training process
- Colostomy
- Pregnancy
- Unresolved deep vein thrombosis
- Uncontrolled autonomic dysreflexia
- Currently involved in another rehabilitation study
- Assessed by physical therapy:
- Severe spasticity that prevents joint motion (severe stiffness or rigidity) in proximal lower extremity muscles, including hip adductors and knee flexors/extensors.
- Hip flexion contracture greater than ~17°
- Knee flexion contracture greater than 12°
- Unable to achieve neutral ankle dorsiflexion with passive stretch (achieve neutral with up to 12° knee flexion)
- Leg length discrepancy greater than 0.5" for upper leg, greater than 0.75" for lower leg
- Spinal instability
- Severe muscular or skeletal pain
- Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
- Shoulder extension range of motion(ROM) < 50° excludes using crutches during sit to stand or vice versa. (Walking with crutches permitted, sit <> stand would be done with walker
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Neurological Institute Mellen Center
Cleveland, Ohio, 44195
About this study
The investigator plans to test the use of the Ekso Bionics® Gait Training (Ekso GT™) exoskeleton for gait training in MS patients. The device will solely be used in the clinic under direct supervision from a physical therapist. This is a small PI-initiated uncontrolled pilot study to gather safety and feasibility data on the exoskeleton in individuals with MS and walking impairment.
Read the detailed description
Powered exoskeletons are approved by the FDA to assist in the rehabilitation of persons with spinal cord injury and post-stroke hemiplegia. The investigator is aware of only one pilot study of a powered exoskeleton (ReWalk®) in multiple sclerosis (MS) which demonstrated some improvements in sitting, standing and walking posture when used consistently. The investigator is not aware of any study of the Ekso GT™ exoskeleton in MS.
This is a feasibility and safety study of using the Ekso GT™ exoskeleton for gait training in patients with relapsing or progressive MS and severe mobility limitations (EDSS 5-5 - 7.5). Preliminary efficacy outcomes on gait and walking will also be collected for the purpose of designing a larger clinical trial of the Ekso GT™ exoskeleton for gait training in patients with MS.
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Being tested
- Ekso GT™ exoskeleton
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ekso GT™ exoskeletonDevice
The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
| Study group | Role | What they receive |
|---|---|---|
| gait training with exoskeleton device | Other | uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton Receives: Device: Ekso GT™ exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout Rate
Percentage of enrolled participants who drop out of the study before the end of the treatment period.
Measured: 0-14 weeks
Adverse Events
.All adverse events were collected throughout the study for each participant, up to 14 weeks",
Measured: 0-14 weeks
Secondary outcomes (1)
Timed 25 Foot Walk
Change in walking speed on the Timed 25 Foot Walk between baseline, end of treatment, and end of follow-up period.
Measured: 0-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start23 Jul 2019
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
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 Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- uncontrolled pre-post intervention study of the use of the Ekso GT™exoskeleton in gait training in the MS population
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francois Bethoux, MD, The Cleveland Clinic
- Investigators
- Francois A Bethoux, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000373
- Sponsor's protocol ID
- 19-580
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2019
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04000373
- Acronym / sponsor ID
- 19-580
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator plans to test the use of the Ekso Bionics® Gait Training (Ekso GT™) exoskeleton for gait training in MS patients. The device will solely be used in the clinic under direct supervision from a physical therapist. This is a small PI-initiated uncontrolled pilot study to gather safety and feasibility data on the exoskeleton in individuals with MS and walking impairment.
Detailed description
Powered exoskeletons are approved by the FDA to assist in the rehabilitation of persons with spinal cord injury and post-stroke hemiplegia. The investigator is aware of only one pilot study of a powered exoskeleton (ReWalk®) in multiple sclerosis (MS) which demonstrated some improvements in sitting, standing and walking posture when used consistently. The investigator is not aware of any study of the Ekso GT™ exoskeleton in MS.
This is a feasibility and safety study of using the Ekso GT™ exoskeleton for gait training in patients with relapsing or progressive MS and severe mobility limitations (EDSS 5-5 - 7.5). Preliminary efficacy outcomes on gait and walking will also be collected for the purpose of designing a larger clinical trial of the Ekso GT™ exoskeleton for gait training in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- uncontrolled pre-post intervention study of the use of the Ekso GT™exoskeleton in gait training in the MS population
| Arm | Type | Receives |
|---|---|---|
| gait training with exoskeleton device | Other | Device: Ekso GT™ exoskeletonuncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of MS per 2017 revised McDonald criteria
- EDSS score 5.5-7.5 (moderate to severe walking disability)
- Cleared for gait training with the study device by the study treating physician
- Device-Specific Criteria
- Involved in a standing program or must be able to tolerate at least 15 min upright without signs or symptoms of orthostatic hypotension
Key exclusion criteria (24 listed)
- • MS exacerbation, severe acute comorbidity or surgery less than 90 days prior to enrollment
- Severe spasticity that prevents joint motion (severe stiffness or rigidity) in proximal lower extremity muscles, including hip adductors and knee flexors/extensors.
- Hip flexion contracture greater than ~17°
- Knee flexion contracture greater than 12°
- Unable to achieve neutral ankle dorsiflexion with passive stretch (achieve neutral with up to 12° knee flexion)
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 GT™ exoskeletonThe rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits. | Device | gait training with exoskeleton device |
Primary outcome
Dropout Rate
Time frame: 0-14 weeks
Percentage of enrolled participants who drop out of the study before the end of the treatment period.
Adverse Events
Time frame: 0-14 weeks
.All adverse events were collected throughout the study for each participant, up to 14 weeks",
1 secondary outcome
Timed 25 Foot Walk
Time frame: 0-14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Francois A Bethoux, MD principal investigator
The Cleveland Clinic
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 GT™ exoskeleton in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by The Cleveland Clinic 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 13 inclusion and 24 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 27 Jun 2022. 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 7 Apr 2020). 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?
Dropout Rate (time frame: 0-14 weeks). 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 27 Jun 2022.