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ReWalk Personal Device Postmarket Study

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ClinicalTrials.gov Identifier: NCT02944669
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
ReWalk Robotics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Injuries, Spinal Cord 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
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]

Secondary Outcome Measures :
  1. Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions [ Time Frame: 12 Months ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with spinal cord injury at levels T7 to L5 and a prescription for the device.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944669


Contacts
Contact: Justin Frazier, MS 508-281-7272 justin.frazier@rewalk.com
Contact: John Hamilton 508-281-7263 john.hamilton@rewalk.com

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Ma Agnes Ith    650-721-7600    mith@stanford.edu   
Principal Investigator: Mathew Smuck, MD         
Casa Colina Hospital Recruiting
Pomona, California, United States, 91767
Contact: Stephanie Kaplan, DPT    909-596-7733 ext 4126    skaplan@casacolina.org   
Contact: Emily Rosario, PhD    909-596-7733 ext 3036    erosario@casacolina.org   
Principal Investigator: Ann Vasile, MD         
United States, Indiana
Rehabilitation Hospital of Indiana Recruiting
Indianapolis, Indiana, United States, 46254
Contact: Elena Gillespie, PhD    317-329-2212    elena.gillespie@rhin.com   
Contact: James Malec, PhD    317-329-2352    jim.malec@rhin.com   
Principal Investigator: Flora Hammond, MD         
Sub-Investigator: Olivia Park, MD         
Sub-Investigator: Julie Chow, MD         
Sponsors and Collaborators
ReWalk Robotics, Inc.
Investigators
Principal Investigator: Mathew Smuck, MD Stanford University

Responsible Party: ReWalk Robotics, Inc.
ClinicalTrials.gov Identifier: NCT02944669     History of Changes
Other Study ID Numbers: RW-401
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD will be made available after the 3-, 6-, and 12-month intervals.

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Back Injuries