Gait Disorders, Neurologic, Multiple Sclerosis
Conditions
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.
Interventions
DEVICEEkso GT™ exoskeleton
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.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
uncontrolled pre-post intervention study of the use of the Ekso GT™exoskeleton in gait training in the MS population
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dropout Rate | 0-14 weeks | Percentage of enrolled participants who drop out of the study before the end of the treatment period. |
| Adverse Events | 0-14 weeks | .All adverse events were collected throughout the study for each participant, up to 14 weeks, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed 25 Foot Walk | 0-14 weeks | Change in walking speed on the Timed 25 Foot Walk between baseline, end of treatment, and end of follow-up period. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited and enrolled between July 2019 and October 2019 in the outpatient clinic.
Participants by arm
| Arm | Count |
|---|---|
| Gait Training With Exoskeleton Device uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Ekso GT™ exoskeleton: 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Gait Training With Exoskeleton Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
| The Expanded Disability Status Scale = 5.5 to 7.5.Range from 0 to 10, higher scores worse outcome | 6.30 units on a scale STANDARD_DEVIATION 0.27 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Adverse Events
.All adverse events were collected throughout the study for each participant, up to 14 weeks,
Time frame: 0-14 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gait Training With Exoskeleton Device | Adverse Events | 4 Participants |
Primary
Dropout Rate
Percentage of enrolled participants who drop out of the study before the end of the treatment period.
Time frame: 0-14 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gait Training With Exoskeleton Device | Dropout Rate | 0 Participants |
Secondary
Timed 25 Foot Walk
Change in walking speed on the Timed 25 Foot Walk between baseline, end of treatment, and end of follow-up period.
Time frame: 0-14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gait Training With Exoskeleton Device | Timed 25 Foot Walk | Baseline to end of follow-up | 1.24 seconds | Standard Deviation 2.87 |
| Gait Training With Exoskeleton Device | Timed 25 Foot Walk | Baseline to end of treatment | 0.72 seconds | Standard Deviation 1.2 |