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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReWalk Personal Device | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with spinal cord injury at levels T7 to L5 and a prescription for the device.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Frazier, MS | Contact | 508-281-7272 | justin.frazier@rewalk.com | |
| John Hamilton | Contact | 508-281-7263 | john.hamilton@rewalk.com |
| Name | Affiliation | Role |
|---|---|---|
| Mathew Smuck, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
De-identified IPD will be made available after the 3-, 6-, and 12-month intervals.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
| Casa Colina Hospital | Recruiting | Pomona | California | 91767 | United States |
|
| Rehabilitation Hospital of Indiana | Recruiting | Indianapolis | Indiana | 46254 | United States |
|
| D014947 | Wounds and Injuries |