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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Gait Disorders, Neurologic
• Intervention / Treatment: Device: Ekso GT™ exoskeleton

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Neurological Institute Mellen Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dropout Rate	Percentage of enrolled participants who drop out of the study before the end of the treatment period.	0-14 weeks
Adverse Events	.All adverse events were collected throughout the study for each participant, up to 14 weeks",	0-14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-14 weeks

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Francois A Bethoux, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): January 9, 2020
• Study Completion (Actual): January 9, 2020

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 19-580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes