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This study will evaluate the Phoenix device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phoenix | Experimental | Phoenix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phoenix | Device | The study to assess safety and efficacy of Phoenix medical exoskeleton. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) | 10 weeks | |
| 6 Minute Walk Test (6MWT) | 10 weeks | |
| 10 Meter Walk Test (10MWT) | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Surface Walk Test | Testing the ability to ambulate with the device on a variety of surfaces | 10 weeks |
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Inclusion Criteria:
At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 100 or less Exercise; Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less
Exclusion Criteria:
1. Pregnant or lactating females 2. Spinal cord injury level higher than T4 3. Severe muscle stiffness/tightness 4. Significant spasticity (Modified Ashworth Scale score of 3 or above) 5. Trunk or lower extremity pressure ulcer 6. Open Wounds 7. Unstable spine, un-healed limbs, or fractures 8. Severe sensitivity to touch 9. Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints 10. Joint instability, dislocation, moderate to severe hip dysplasia 11. Significant scoliosis (>40 degrees) 12. Hardware, implant, or any external device impeding with safe fitting or use of Phoenix 13. Femoral or tibial rotation deformity (>15 degrees) 14. Significant flexion contractures limited to 35º at the hip and 20º at the knee 15. Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past year.
16. Known history of pulmonary disease limiting exercise tolerance or history of cardiac disease 17. Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton.
18. Severe concurrent medical diseases, illness, systemic or peripheral infection 19. Dizziness or headache with standing 20. History of autonomic dysreflexia 21. Orthostatic Hypotension: Decrease in Systolic BP > 20, Diastolic BP > 10 upon standing from a seated position.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| suitX | Emeryville | California | 94608 | United States | ||
| Motion & Gait Lab, Lucile Packard Children's Hospital Stanford |
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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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| Menlo Park |
| California |
| 94025 |
| United States |
| St. David's Medical Center, Rehabilitation Hospital | Austin | Texas | 78705 | United States |
| The University of Hong Kong | Hong Kong | Hong Kong |
| D014947 | Wounds and Injuries |