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

ReWalk Robotics

Status

Unknown

Conditions

Cerebrovascular Accident

Stroke

Stroke Hemorrhagic

Stroke, Acute

Hemiparesis

Hemiplegia

Treatments

Device: ReWalk ReStore device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03499210

CLN0011

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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