Recruiting

ReWalk

Sponsor:

ReWalk Robotics, Inc.

Code:

NCT02944669

Conditions

Injuries, Spinal Cord

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ReWalk Personal Device

Study Details

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.

Conditions

Injuries, Spinal Cord

Study ID

NCT02944669

Start date

Jun, 2016

Status verified date

Feb, 2017

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

ReWalk Personal Device

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Justin Frazier, MS

508-281-7272justin.frazier@rewalk.com

John Hamilton

508-281-7263john.hamilton@rewalk.com

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Ma Agnes Ith

650-721-7600mith@stanford.edu

Principal Investigator:

Mathew Smuck, MD

Casa Colina Hospital

Recruiting

Pomona, California, United States, 91767

Contacts

Stephanie Kaplan, DPT

909-596-7733skaplan@casacolina.org

Emily Rosario, PhD

909-596-7733erosario@casacolina.org

Principal Investigator:

Ann Vasile, MD

Rehabilitation Hospital of Indiana

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

Elena Gillespie, PhD

317-329-2212elena.gillespie@rhin.com

James Malec, PhD

317-329-2352jim.malec@rhin.com

Principal Investigator:

Flora Hammond, MD

More Information

Sponsor

ReWalk Robotics, Inc.

Last update posted

Feb 2, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ReWalk Robotics, Inc. on 2017-02-02.