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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02983955
Other study ID # UPNRIDE-UR-SF-01
Secondary ID
Status Recruiting
Phase N/A
First received November 22, 2016
Last updated December 1, 2016
Start date November 2016
Est. completion date January 2017

Study information

Verified date December 2016
Source UPnRIDE Robotics Ltd.
Contact Shany Kheifets-Zohar, Bsc.
Phone 972-4-6110061
Email shany@upnride.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
UPnRIDE Powered Wheelchair
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.

Locations

Country Name City State
Israel The Chaim Sheba Medical Center Ramat Gan

Sponsors (2)

Lead Sponsor Collaborator
UPnRIDE Robotics Ltd. Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Through study completion, an average of 3 months Yes
Secondary Successes rate of task performance Study success is defined if 70% of study subjects are defined success Through study completion, an average of 3 months No
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