Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Indi
Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Ekso GT™ exoskeleton
Results by group
Dropout Rate
0-14 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Gait Training With Exoskeleton Device | 0 Participants | 5 |
Adverse Events
0-14 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Gait Training With Exoskeleton Device | 4 Participants | 5 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Gait Training With Exoskeleton Device | 5 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Dropout Rate
0-14 weeks
Adverse Events
0-14 weeks
Safety
Other measures (1)
Timed 25 Foot Walk
0-14 weeks
Disability progressionWalking and mobility
Who could take part
MS (type not specified) · 18 and over · EDSS 5.5 to 7.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jul 2019
Main results due
Jan 2020
Finished
Jan 2020
Results posted
Apr 2020