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Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke | Clinical Trials | Clareo Health

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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

NCT03499210•ReWalk Robotics, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

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

Locations (5)

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Spaulding Rehabilitation Institute

Boston, Massachusetts, United States

Kessler Foundation

West Orange, New Jersey, United States

Moss Rehab

Elkins Park, Pennsylvania, United States

TIRR Memorial Hermann

Houston, Texas, United States

Key Dates

Start Date

March 29, 2018

Primary Completion Date

November 30, 2018

Completion Date

November 30, 2018

Last Updated

November 7, 2018

Enrollment

ESTIMATED participants

Conditions

StrokeStroke, AcuteStroke HemorrhagicHemiparesisHemiplegiaCerebrovascular Accident

Interventions

ReWalk ReStore device

DEVICE

Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

NCT06258538

Stroke Patients

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RECRUITINGNA

Cerebellar Stimulation for Aphasia Rehabilitation

NCT05093673

Stroke

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RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

Cerebellar Stimulation for Aphasia Rehabilitation

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Mirror Therapy Rehabilitation of the Upper Limb After Stroke (NEURO-MIROIR 2)