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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2018-11-30

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.

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Detailed Description

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Conditions

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Stroke Stroke, Acute Stroke Hemorrhagic Hemiparesis Hemiplegia Cerebrovascular Accident

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Investigational group

All subjects will participate in study procedures involving use of the ReWalk ReStore device.

Group Type EXPERIMENTAL

ReWalk ReStore device

Intervention Type DEVICE

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.

Interventions

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ReWalk ReStore device

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No