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

November 6, 2018 updated by: ReWalk Robotics, Inc.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan AbilityLab
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Spaulding Rehabilitation Institute
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Moss Rehab
    • Texas
      • Houston, Texas, United States, 77030
        • TIRR Memorial Hermann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational group
All subjects will participate in study procedures involving use of the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of device-related adverse events [Safety]
Time Frame: 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.
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]
Time Frame: 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.
duration of study completion for each site, estimated 4 months
Incidence of injury to physical therapist caused by device [PT safety]
Time Frame: 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.
duration of study completion for each site, estimated 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed measured with 10 Meter Walk Test
Time Frame: duration of study participation for each subject, estimated 4 weeks
Subjects will perform a 10 Meter Walk Test to evaluate walking speed with and without the ReStore device.
duration of study participation for each subject, estimated 4 weeks
Gait analysis using a gait mat
Time Frame: duration of study participation for each subject, estimated 4 weeks
Subjects will walk across a gait mat device (such as GAITRite) which records step timing and step placement in order to evaluate their walking with and without the ReStore device.
duration of study participation for each subject, estimated 4 weeks
Walking distance measured with 2 Minute Walk Test
Time Frame: duration of study participation for each subject, estimated 4 weeks
Subjects will perform a 2 Minute Walk Test (2MWT) to evaluate the 2 minute walking distance with the ReStore device in Slack, Assist, and Brace modes
duration of study participation for each subject, estimated 4 weeks
Modified QUEST questionnaire [subject satisfaction]
Time Frame: duration of study participation for each subject, estimated 4 weeks
Subjects will complete a modified QUEST questionnaire (Quebec User Evaluation of Assistive Technology) to indicate their level of satisfaction with the ReStore device (on a scale from 1 to 5) in 8 different categories.
duration of study participation for each subject, estimated 4 weeks
Physical Therapist satisfaction questionnaire [PT satisfaction]
Time Frame: duration of study completion for each site, estimated 4 months
Physical Therapists involved in the study will complete a PT satisfaction questionnaire at the end of the study to indicate their level of satisfaction (on a scale from 1 to 5) with the ReStore device in 9 different categories.
duration of study completion for each site, estimated 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2018

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

November 30, 2018

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on ReWalk ReStore device

Subscribe