ReWalk Personal Device Postmarket Study
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
1 other identifier
observational
60
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedFebruary 2, 2017
February 1, 2017
3.3 years
October 24, 2016
February 1, 2017
Conditions
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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
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 Outcomes (4)
Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions
12 Months
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
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
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
Interventions
Eligibility Criteria
Individuals with spinal cord injury at levels T7 to L5 and a prescription for the device.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Stanford University
Palo Alto, California, 94304, United States
Casa Colina Hospital
Pomona, California, 91767, United States
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathew Smuck, MD
Stanford University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 26, 2016
Study Start
June 1, 2016
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
February 2, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
De-identified IPD will be made available after the 3-, 6-, and 12-month intervals.