ReWalk Personal Device Postmarket Study
Status unconfirmed
Conditions studied: Injuries, Spinal Cord
In brief
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.
Key facts
- Study ID
- NCT02944669
- Run by
- ReWalk Robotics, Inc.
- People needed
- 60
- Starts
- 2016-06-01
- Expected to finish
- 2019-09-01
- Last updated by the study team
- 2017-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Stanford University — Palo Alto, California, United States (enrolling)
- Casa Colina Hospital — Pomona, California, United States (enrolling)
- Rehabilitation Hospital of Indiana — Indianapolis, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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