SCI - Spinal Cord InjuryNCT03175055
Phoenix Exoskeleton for SCI Users
A study testing Phoenix in people with SCI - Spinal Cord Injury, run by US Bionics at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Phoenix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jun 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
St. David's Medical Center, Rehabilitation Hospital
Austin, Texas, 78705
suitX
Emeryville, California, 94608
Motion & Gait Lab, Lucile Packard Children's Hospital Stanford
Menlo Park, California, 94025
About this study
Official title: 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.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- Phoenix
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhoenixDevice
The study to assess safety and efficacy of Phoenix medical exoskeleton.
| Study group | Role | What they receive |
|---|---|---|
| Phoenix | Experimental | Phoenix Receives: Device: Phoenix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Measured: 10 weeks
6 Minute Walk Test (6MWT)
Measured: 10 weeks
10 Meter Walk Test (10MWT)
Measured: 10 weeks
Secondary outcomes (1)
Surface Walk Test
Testing the ability to ambulate with the device on a variety of surfaces
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175055
- Sponsor's protocol ID
- 10133
- Status last verified
- May 2018
- First submitted
- 31 May 2017
- Last updated
- 1 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phoenix Exoskeleton Clinical Study
- ClinicalTrials.gov ID
- NCT03175055
- Acronym / sponsor ID
- 10133
- Conditions
- SCI - Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- US BionicsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phoenix | Experimental | Device: PhoenixPhoenix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhoenixThe study to assess safety and efficacy of Phoenix medical exoskeleton. | Device | Phoenix |
Primary outcome
Timed Up and Go (TUG)
Time frame: 10 weeks
6 Minute Walk Test (6MWT)
Time frame: 10 weeks
10 Meter Walk Test (10MWT)
Time frame: 10 weeks
1 secondary outcome
Surface Walk Test
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phoenix in people with SCI - Spinal Cord Injury, run by US Bionics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.