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

This is an interventional treatment trial for Multiple Sclerosis Read More

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