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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational group
All subjects will participate in study procedures involving use of the ReWalk ReStore device.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ReWalk Robotics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spaulding Rehabilitation Hospital
Kessler Foundation
TIRR Memorial Hermann
Shirley Ryan AbilityLab
Moss Rehabilitation Research Institute

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLN0011

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.

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