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

NCT04000373 | Completed Results FDA Device

• 1 other identifier: 19-580
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Timed 25 Foot Walk

  0-14 weeks

Study Arms (1)

gait training with exoskeleton device

OTHER

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

Device: Ekso GT™ exoskeleton

Interventions

Ekso GT™ exoskeleton 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.

gait training with exoskeleton device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Neurological Institute Mellen Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Nurse Coordinator
• Organization: Cleveland Clinic Neurological Institute Mellen Center

stoughd@ccf.org

216-445-5877

Study Officials

• Francois A Bethoux, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rehabilitation Services at the Cleveland Clinic Mellen Center.

Model Details: uncontrolled pre-post intervention study of the use of the Ekso GT™exoskeleton in gait training in the MS population

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 27, 2019
• Study Start: July 23, 2019
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: June 27, 2022
• Results First Posted: April 7, 2020

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)