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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke, Stroke, Acute, Stroke Hemorrhagic, Hemiparesis, Hemiplegia, Cerebrovascular Accident

Intervention / Treatment
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* Device: ReWalk ReStore device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational group<br>All subjects will participate in study procedures involving use of the ReWalk ReStore device. | Device: ReWalk ReStore device<br>* The ReWalk ReStore device is intended to be used to perform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device-related adverse events [Safety] | Safety will be evaluated on the basis of the number of device-related adverse events reported for subjects during their participation in the study. | duration of study participation for each subject, estimated 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device malfunctions during study procedures [Device Reliability] | Device reliability will be evaluated on the basis of the number of device malfunctions reported by research study staff for the duration of study procedures at each study site. | duration of study completion for each site, estimated 4 months | 
| Incidence of injury to physical therapist caused by device [PT safety] | PT safety will be evaluated on the basis of the number of device-related injuries reported by study physical therapists for the duration of study procedures at each study site. | duration of study completion for each site, estimated 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Exoskeleton, Hemiparesis, Hemiplegia