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