NCT03175055

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

May 31, 2017

Last Update Submit

May 30, 2018

Conditions

SCI - Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go (TUG)

    10 weeks

  • 6 Minute Walk Test (6MWT)

    10 weeks

  • 10 Meter Walk Test (10MWT)

    10 weeks

Secondary Outcomes (1)

  • Surface Walk Test

    10 weeks

Study Arms (1)

Phoenix

EXPERIMENTAL

Phoenix

Device: Phoenix

Interventions

PhoenixDEVICE

The study to assess safety and efficacy of Phoenix medical exoskeleton.

Phoenix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years of age or older in general good health
  • Weigh no more than 220lbs
  • Skin must be healthy where it touches the Phoenix
  • Able to stand using a device such as a standing frame
  • Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
  • Have good control of upper body
  • 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
  • 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
  • Hip width no greater than 18" (46 cm) measured when sitting.
  • Femur length between 12.3 inches (31.3 cm) and 19.8 inches (50.2 cm) measured between centers of hip and knee joints.
  • 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.
  • In general good health and able to tolerate moderate levels of activity.
  • 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

You may not qualify if:

  • \. 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.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

suitX

Emeryville, California, 94608, United States

Location

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

Menlo Park, California, 94025, United States

Location

St. David's Medical Center, Rehabilitation Hospital

Austin, Texas, 78705, United States

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 5, 2017

Study Start

June 1, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

June 1, 2018

Record last verified: 2018-05

Locations

US(3)HK(1)