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Phoenix Exoskeleton for SCI Users | Clinical Trials | Clareo Health

COMPLETEDNA

Phoenix Exoskeleton for SCI Users

Phoenix Exoskeleton Clinical Study

NCT03175055•US Bionics

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 Years of age or older in general good health
•2. Weigh no more than 220lbs
•3. Skin must be healthy where it touches the Phoenix
•4. Able to stand using a device such as a standing frame
•5. Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
•6. Have good control of upper body
•7. Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal MD
•8. Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
•9. Hip width no greater than 18" (46 cm) measured when sitting.
•10. Femur length between 12.3 inches (31.3 cm) and 19.8 inches (50.2 cm) measured between centers of hip and knee joints.
+4 more criteria

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.

Locations (4)

suitX

Emeryville, California, United States

Motion & Gait Lab, Lucile Packard Children's Hospital Stanford

Menlo Park, California, United States

St. David's Medical Center, Rehabilitation Hospital

Austin, Texas, United States

The University of Hong Kong

Hong Kong, Hong Kong

Key Dates

Start Date

June 1, 2017

Primary Completion Date

May 31, 2018

Completion Date

May 31, 2018

Last Updated

June 1, 2018

Enrollment

ACTUAL participants

Conditions

SCI - Spinal Cord Injury

Interventions

Phoenix

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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