ReWalk Personal Device Postmarket Study

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: Unknown
• Conditions: Injuries, Spinal Cord
• Intervention / Treatment: Device: ReWalk Personal Device

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: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

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: Stephanie Kaplan, DPT; Phone Number: 4126 909-596-7733; Email: skaplan@casacolina.org
      • Principal Investigator: Ann Vasile, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Recruiting
      • Rehabilitation Hospital of Indiana
      • Contact: Elena Gillespie, PhD; Phone Number: 317-329-2212; Email: elena.gillespie@rhin.com
      • Contact: James Malec, PhD; Phone Number: 317-329-2352; Email: jim.malec@rhin.com
      • Sub-Investigator: Olivia Park, MD
      • Sub-Investigator: Julie Chow, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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	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	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	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	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	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	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	12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions	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	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	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	12 Months

Collaborators and Investigators

• Sponsor: ReWalk Robotics, Inc.
• Investigators: Principal Investigator: Mathew Smuck, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (ESTIMATE): October 26, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Back Injuries; Spinal Cord Injuries; Spinal Injuries
• Other Study ID 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