N/A
N=5
Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
Multiple Sclerosis · Gait Disorders, Neurologic
Bottom Line
View on ClinicalTrials.gov: NCT04000373 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Dropout Rate — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ekso GT™ exoskeleton (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dropout Rate |
— | — |
| PRIMARY Adverse Events |
4 | — |
| SECONDARY Timed 25 Foot Walk |
0.72; 1.24 | — |
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.
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
- stand would be done with walker
Data sourced from ClinicalTrials.gov (NCT04000373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.