Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis

Loss of the ability to walk is one of the significant problems in persons with multiple
sclerosis (MS). This limitation prevents the person from having an active and meaningful
life at home and in the community. Also, more energy is needed to walk, which can cause
fatigue and further leads to a non-active life style and poor quality of life.
Unfortunately, walking training is often not available for this population because of the
severity and progress of the disease; therefore, a new strategy is needed to help people
with MS to walk again. A new technology, the wearable robotic exoskeleton, has been
developed to help persons with spinal cord injuries stand up and walk. The robotic legs are
powered by batteries and controlled by motors. This study will investigate the use of a
wearable robotic exoskeleton to help persons with MS to walk. Participants will receive
trainings (5 days per week for 3 weeks) to walk with the robotic exoskeleton (EKSO, EKSO
Bionics, Richmond, CA). During the training, a physical therapist will teach the participant
how to maintain balance, sit to stand, stand to sit, and walk with the wearable robotic
exoskeleton. The hypothesis is that persons with MS will be able to use a robotic
exoskeleton to walk better and with less energy costs.

Subjects will be enrolled if they meet the following inclusion criteria:

- Age 18 years or older

- Ambulatory with assistive devices (Ambulation status will be determined by the EDSS
score)

- With an Expanded Disability Status Scale (EDSS) score between 6 and 7.5 inclusive

- Height and weight are between 160 and 188 cm (5'2'' to 6'2''), and less than 100 kg
(220 lb), respectively (per exoskeleton manufacturer)

- Able to follow simple 3 step commends

- Able to understand the study procedure and consent form

Subjects will be excluded if they have any of the following exclusion criteria:

- History of severe neurologic injuries other than MS (Spinal Cord Injury, Cerebral
Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Cerebral Vascular
Accident, etc.)

- Severe comorbidities:

- active infections

- heart, lung, or circulatory conditions

- pressure ulcers

- Documented severe osteoporosis affecting the hip and spine

- Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled
clonus

- Unhealed limb or pelvic fractures

- Skin issues that would prevent wearing the device

- Range of motion restrictions that would prevent subject from achieving a normal,
reciprocal gait pattern, or would restrict a subject from completing normal sit to
stand or stand to sit transitions.

- Upper extremity strength deficits that limit ability to balance with a front rolling
walker or crutches.

- Heterotopic ossification that resists functional range of motion in lower extremities

- Contractures (>15 degrees at the hips or >20 degrees at the knees)

- Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity
concerns

- Colostomy

- Have received any physical therapy intervention within 3 months prior to enrolment in
the study

- Non-English speaking