Clinical trial NCT04000373: Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
Official title: Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Gait Disorders, Neurologic
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: uncontrolled pre-post intervention study of the use of the Ekso GT™exoskeleton in gait training in the MS population
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dropout Rate
timeFrame: 0-14 weeks
measure: Adverse Events
timeFrame: 0-14 weeks
Secondary outcomes:
measure: Timed 25 Foot Walk
timeFrame: 0-14 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Neurological Institute Mellen Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Francois A Bethoux, MD
role: PRINCIPAL_INVESTIGATOR
References: