ReWalk Personal Device Postmarket Study

Injuries, Spinal Cord Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944669
• Other study ID #: RW-401
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2016
• Last updated: February 1, 2017
• Start date: June 2016
• Est. completion date: September 2019

Study information

• Verified date: February 2017
• Source: ReWalk Robotics, Inc.
• Contact: Justin Frazier, MS
• Phone: 508-281-7272
• Email: justin.frazier[@]rewalk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Injuries, Spinal Cord
• Spinal Cord Injuries
• Spinal Injuries

Intervention

Device:
• ReWalk Personal Device

Locations

Country	Name	City	State
United States	Rehabilitation Hospital of Indiana	Indianapolis	Indiana
United States	Stanford University	Palo Alto	California
United States	Casa Colina Hospital	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
ReWalk Robotics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions		12 Months
Secondary	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
Secondary	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
Secondary	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