Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke

Inclusion Criteria:

- History of one-sided ischemic or hemorrhagic stroke (>2 weeks post stroke)

- Presentation of hemiparesis/hemiplegia resulting from stroke

- At least 18 years of age

- Height of 4'8" - 6'7"

- Weight of less than 264 lbs

- Medical clearance by a clinician treating the subject

- Able to ambulate at least 5 feet without an ankle foot orthosis (AFO), with no more
than minimal contact assistance from a PT

- Able to follow a 3-step command

- Able to fit suit components (waistbelt, calf wrap)

- No greater than 5 degrees of plantar flexion contracture during passive ankle ROM

- Modified Ashworth Scale for spasticity at 3 or less for ankle dorsi-flexors and
plantar-flexors

Exclusion Criteria:

- Severe aphasia limiting ability to express needs or discomfort verbally or
non-verbally

- Serious co-morbidities that, in the opinion of the investigator, may interfere with
ability to participate

- History of significant Peripheral Artery Disease

- Colostomy bag

- Current pregnancy

- Uncontrolled or untreated hypertension

- Currently participating in any other ongoing clinical trial

- Presence of open wounds or broken skin at device locations requiring medical
management

- Known urethane allergies

- Current medical diagnosis of DVT