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

NCT03499210 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-11-07

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Shirley Ryan AbilityLab

    collaborator OTHER

  • Kessler Foundation

    collaborator OTHER

  • TIRR Memorial Hermann

    collaborator OTHER

  • Spaulding Rehabilitation Hospital

    collaborator OTHER

  • Moss Rehabilitation Research Institute

    collaborator OTHER

  • ReWalk Robotics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499210 on ClinicalTrials.gov