ReWalk Personal Device Postmarket Study

Therapuetic Areas:Other
Age Range:18 - Any
Start Date:June 2016
End Date:September 2019
Contact:Justin Frazier, MS

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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.

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.

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,

- 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
We found this trial at
Palo Alto, California 94304
Principal Investigator: Mathew Smuck, MD
Phone: 650-721-7600
Palo Alto, CA
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Indianapolis, Indiana 46254
Principal Investigator: Flora Hammond, MD
Phone: 317-329-2212
Indianapolis, IN
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255 East Bonita Avenue
Pomona, California 91767
Principal Investigator: Ann Vasile, MD
Phone: 909-596-7733
Pomona, CA
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