ReWalk Personal Device Postmarket Study

February 1, 2017 updated by: ReWalk Robotics, Inc.

Long-Term, Prospective, Non-Interventional Study Monitoring Safety and Training in Patients With Spinal Cord Injuries and Their Trained Companions Recently Initiated With the ReWalk™ Personal Device

This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice.

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.

Detailed Description

This study will monitor and further describe the long-term safety of the ReWalk Personal Device for Subjects and their Companions in institutional and non-institutional environments, such as the clinic, home, and community. The study will also evaluate the adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, their Companions, and their Clinical Trainers, monitor and further describe all ReWalk Personal Device malfunctions and screen for potential Unexpected Adverse Events.

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.
Observational

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.
60

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Mathew Smuck, MD
      • Pomona, California, United States, 91767
        • Recruiting
        • Casa Colina Hospital
        • Contact:
        • Principal Investigator:
          • Ann Vasile, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Recruiting
        • Rehabilitation Hospital of Indiana
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Olivia Park, MD
        • Sub-Investigator:
          • Julie Chow, MD

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with spinal cord injury at levels T7 to L5 and a prescription for the device.

Description

Inclusion Criteria:

  • For use in institutional and non-institutional environments: Subjects with spinal cord injury at levels T7 to L5.
  • Age ≥ 18 years old;
  • Hands and shoulders can support crutches or a walker;
  • Healthy bone density;
  • Skeleton does not suffer from any fractures;
  • Able to stand using a device such as EasyStand;
  • In general good health;
  • Height is between 160 cm and 190 cm (5'3" - 6'2");
  • Weight does not exceed 100 kg (220 lbs);
  • Proficiency in spoken and written English language.

Exclusion Criteria:

  • History of severe neurological injuries or disease other than SCI (MS, CP, ALS, TBI, etc.);
  • Severe concurrent medical disease, including infections, circulatory, heart or lung, pressure sores;
  • Severe spasticity (Ashworth 4)
  • Uncontrolled clonus;
  • Unstable spine or unhealed limbs or pelvic fractures;
  • Heterotopic ossification;
  • Significant contractures;
  • Psychiatric or cognitive situations that may interfere with proper operation of the device or participation in this study;
  • Pregnancy

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

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
Time Frame
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Subjects
Time Frame: 12 Months
12 Months
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of falls and fall- associated injuries
Time Frame: 12 Months
12 Months
Long-term safety of the ReWalk Personal Device for Companions in institutional and non-institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Companions
Time Frame: 12 Months
12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects enrolled in training who successfully complete the intended training
Time Frame: 12 Months
12 Months
Adequacy of the ReWalk Training Program for Subjects, measured by the proportion of Subjects who successfully completed the intended training who are able to demonstrate proficiencies at 12 months after completion of the intended training
Time Frame: 12 Months
12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the Subjects' abilities to navigate surfaces and environments outside of the institutional environment in accordance with their training
Time Frame: 12 Months
12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the proportion of Companions enrolled in training who successfully complete the intended training
Time Frame: 12 Months
12 Months

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
Time Frame
Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions
Time Frame: 12 Months
12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning
Time Frame: 12 Months
12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning
Time Frame: 12 Months
12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Clinical Trainers, as measured by the qualitative Clinical Trainer responses to directed and open-ended questioning
Time Frame: 12 Months
12 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.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mathew Smuck, MD, Stanford University

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

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.
June 1, 2016

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.
September 1, 2019

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.
September 1, 2019

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).
October 24, 2016

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.
October 25, 2016

First Posted (ESTIMATE)

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.
October 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

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.
February 2, 2017

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.
February 1, 2017

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.
February 1, 2017

More Information

Terms related to this study

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.
  • RW-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD will be made available after the 3-, 6-, and 12-month intervals.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

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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