Spinal Cord Injury CervicalUPNRIDE_SAFENCT02983955
UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability
A study testing UPnRIDE Powered Wheelchair in people with Spinal Cord Injury Cervical, run by UPnRIDE Robotics Ltd. at 1 site in Israel.
Trial summary
The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- UPnRIDE Powered Wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Jan 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, non-lactating females
- Ages 18-70
- Suffered from a SCI which caused Tetraplegia, ASIA A-B-C
- At least 1 year after SCI
- Height of 155 to 190 cm;
- Weight less than 100 kg
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- Able to sign informed consent.
- Power or manual wheelchair user as a primary means of mobility
- Regular user of a standing frame or tilt table for at least 30 minutes a week Exclusion Criteria
- 1. History of severe neurological disorder other than SCI (multiple sclerosis, cerebral palsy, amyotrophic lateral sclerosis, traumatic brain injury, stroke, etc.) 2. Concurrent severe medical disease 3. Pressure sores 4. Unstable spine 5. Unhealed limb or pelvic fractures 6. Psychiatric or cognitive status that may interfere with the trial
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Chaim Sheba Medical Center
Ramat Gan
Amihai Gottlieb
About this study
The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.
The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as an outdoor and indoor mobility device by individuals with walking impairment.
Read the detailed description
A new powered wheelchair has recently been developed to address the ability of the user to be able to position them in an upright, standing position. This new device is called the UPnRIDE powered wheelchair and is different from other upright wheelchairs because current standing wheelchair models have limited mobility in the standing position. The UPnRIDE is an upright or seated mobility device that is intended to provide full upright standing posture in a mobile powered wheelchair. The UPnRIDE powered wheelchair provides wheelchair and scooter users the ability to engage in society in either a standing (upright mobility) or seated position (seated mobility). Additionally, the option to have upright posture throughout the day may have the potential to improve some of the secondary medical conditions associated with the extreme sedentary lifestyle that paralysis from SCI imposes. This wheeled, motorized device can provide mobility to most urban environment situations by being able to be navigated indoors and outdoors and over different surfaces in both the standing or seated positions.
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- UPnRIDE Powered Wheelchair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPnRIDE Powered WheelchairDevice
The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.
| Study group | Role | What they receive |
|---|---|---|
| SCI with Tetraplegia | Other | Not described Receives: Device: UPnRIDE Powered Wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Through study completion, an average of 3 months
Secondary outcomes (1)
Successes rate of task performance
Study success is defined if 70% of study subjects are defined success
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UPnRIDE Robotics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Gabi Zeilig, MD, Principal investigator, Department of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983955
- Sponsor's protocol ID
- UPNRIDE-UR-SF-01
- Acronym
- UPNRIDE_SAFE
- Status last verified
- Dec 2016
- First submitted
- 22 Nov 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability
- ClinicalTrials.gov ID
- NCT02983955
- Acronym / sponsor ID
- UPNRIDE_SAFE / UPNRIDE-UR-SF-01
- Conditions
- Spinal Cord Injury Cervical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- UPnRIDE Robotics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- 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.
The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.
The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as an outdoor and indoor mobility device by individuals with walking impairment.
Detailed description
A new powered wheelchair has recently been developed to address the ability of the user to be able to position them in an upright, standing position. This new device is called the UPnRIDE powered wheelchair and is different from other upright wheelchairs because current standing wheelchair models have limited mobility in the standing position. The UPnRIDE is an upright or seated mobility device that is intended to provide full upright standing posture in a mobile powered wheelchair. The UPnRIDE powered wheelchair provides wheelchair and scooter users the ability to engage in society in either a standing (upright mobility) or seated position (seated mobility). Additionally, the option to have upright posture throughout the day may have the potential to improve some of the secondary medical conditions associated with the extreme sedentary lifestyle that paralysis from SCI imposes. This wheeled, motorized device can provide mobility to most urban environment situations by being able to be navigated indoors and outdoors and over different surfaces in both the standing or seated positions.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCI with Tetraplegia | Other | Device: UPnRIDE Powered Wheelchair |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and non-pregnant, non-lactating females
- Ages 18-70
- Suffered from a SCI which caused Tetraplegia, ASIA A-B-C
- At least 1 year after SCI
- Height of 155 to 190 cm;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| UPnRIDE Powered WheelchairThe UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility. | Device | SCI with Tetraplegia |
Primary outcome
Adverse events
Time frame: Through study completion, an average of 3 months
1 secondary outcome
Successes rate of task performance
Time frame: Through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Gabi Zeilig, MD principal investigator
Department of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPnRIDE Powered Wheelchair in people with Spinal Cord Injury Cervical, run by UPnRIDE Robotics Ltd. at 1 site in Israel.
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 10 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shany Kheifets-Zohar, Bsc. (972-4-6110061, shany@upnride.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through study completion, an average of 3 months). 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 6 Dec 2016.