Clinical trial NCT03175055: Phoenix Exoskeleton for SCI Users
Official title: Phoenix Exoskeleton Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SCI - Spinal Cord Injury
Lead sponsor: US Bionics
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 criteria: 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.

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 10 weeks
measure: 6 Minute Walk Test (6MWT)
timeFrame: 10 weeks
measure: 10 Meter Walk Test (10MWT)
timeFrame: 10 weeks
Secondary outcomes:
measure: Surface Walk Test
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Emeryville
country: United States
facility: suitX
state: California
city: Menlo Park
country: United States
facility: Motion & Gait Lab, Lucile Packard Children's Hospital Stanford
state: California
city: Austin
country: United States
facility: St. David's Medical Center, Rehabilitation Hospital
state: Texas
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References: