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

A Multi-site, Interventional, Non-comparative, Single-arm Trial to Evaluate the Safety of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Ischemic or Hemorrhagic Stroke

A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic 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