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Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04000373
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Francois Bethoux, MD, The Cleveland Clinic

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Gait Disorders, Neurologic Device: Ekso GT™ exoskeleton Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
gait training with exoskeleton device
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Device: Ekso GT™ exoskeleton
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.




Primary Outcome Measures :
  1. Dropout rate [ Time Frame: 0-14 weeks ]
    Percentage of enrolled participants who drop out of the study before the end of the treatment period.

  2. Adverse events [ Time Frame: 0-14 weeks ]
    Number of participants with adverse events occurring during or between treatment sessions.


Secondary Outcome Measures :
  1. Timed 25 Foot Walk [ Time Frame: 0-14 weeks ]
    Change in walking speed on the Timed 25 Foot Walk between baseline, end of treatment, and end of follow-up period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • • 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
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000373


Contacts
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Contact: Research Nurse Coordinator 216-445-5877 stoughd@ccf.org
Contact: Research Regulatory and QA Manager 216-444-5682 OCONNOK@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Neurological Institute Mellen Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Francois A Bethoux, MD The Cleveland Clinic

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Responsible Party: Francois Bethoux, MD, Director of Rehabilitation Services at the Cleveland Clinic Mellen Center., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04000373     History of Changes
Other Study ID Numbers: Exoskeleton Use IN MS
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Nervous System Diseases
Gait Disorders, Neurologic
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Signs and Symptoms