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

NCT ID: NCT04000373

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2020-01-09

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gait training with exoskeleton device

uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton

Group Type: OTHER

Ekso GT™ exoskeleton

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Francois Bethoux, MD

Director of Rehabilitation Services at the Cleveland Clinic Mellen Center.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francois A Bethoux, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Neurological Institute Mellen Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-580

Identifier Type: -

Identifier Source: org_study_id