ReWalk Personal Device Postmarket Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Injuries, Spinal Cord

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ReWalk Personal Device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No