Clinical trial NCT02983955: UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability
Official title: UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury Cervical
Lead sponsor: UPnRIDE Robotics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sheba Medical Center
First posted: 2016-12-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

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.

Eligibility criteria: Inclusion Criteria

1. Males and non-pregnant, non-lactating females
2. Ages 18-70
3. Suffered from a SCI which caused Tetraplegia, ASIA A-B-C
4. At least 1 year after SCI
5. Height of 155 to 190 cm;
6. Weight less than 100 kg
7. Able to sign informed consent.
8. Power or manual wheelchair user as a primary means of mobility
9. 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

Primary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Successes rate of task performance
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
Study officials:
affiliation: Department of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine,
name: Gabi Zeilig, MD
role: PRINCIPAL_INVESTIGATOR
References: