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

Not Applicable

• Conditions: Stroke Hemorrhagic; Stroke; Hemiplegia; Stroke, Acute; Hemiparesis; Cerebrovascular Accident
• Interventions: Device: ReWalk ReStore device

• Registration Number: NCT03499210
• Lead Sponsor: ReWalk Robotics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-27
• Study Start: 2018-03-29
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-07
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational group	ReWalk ReStore device	All subjects will participate in study procedures involving use of the ReWalk ReStore device.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of device malfunctions during study procedures [Device Reliability]	duration of study completion for each site, estimated 4 months	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.
Incidence of injury to physical therapist caused by device [PT safety]	duration of study completion for each site, estimated 4 months	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.

Trial Locations

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