ReWalk Personal Device Postmarket Study

ReWalk Robotics

Status: Unknown

Conditions: Injuries, Spinal Cord

Treatments: Device: ReWalk Personal Device

Study type: Observational

Funder types: Industry

Identifiers

NCT02944669

RW-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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