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

Completed · Not applicable

Conditions studied: Multiple Sclerosis, Gait Disorders, Neurologic

In brief

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.

Key facts

Study ID: NCT04000373
Run by: The Cleveland Clinic
People needed: 5
Starts: 2019-07-23
Expected to finish: 2020-01-09
Last updated by the study team: 2022-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
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

Where it is running

Cleveland Clinic Neurological Institute Mellen Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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