Phoenix Exoskeleton for SCI Users



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:6/2/2018
Start Date:June 1, 2017
End Date:May 31, 2018

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Phoenix Exoskeleton Clinical Study

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.


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.

11. Tibia length between 13.4 inches (33.9 cm) and 22 (55.9 cm) inches measured between
the knee joint and bottom of the foot.

12. In general good health and able to tolerate moderate levels of activity.

13. Blood pressure and heart rate within established guidelines for locomotive training:

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.
We found this trial at
4
sites
Hong Kong,
Principal Investigator: Paul A Koljonen, MBBS (HK)
Phone: (852) 2255-4654
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Hong Kong,
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919 East 32nd Street
Austin, Texas 78705
Principal Investigator: Juan M Latorre, MD
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Austin, TX
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Emeryville, California 94608
Principal Investigator: Anna Sternin, DPT
Phone: 510-610-2188
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Emeryville, CA
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725 Welch Road
Menlo Park, California 94025
Principal Investigator: Jessica Rose, PhD
Phone: 510-610-2188
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Menlo Park, CA
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