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UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability

NCT ID: NCT02983955

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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

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Spinal Cord Injury Cervical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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SCI with Tetraplegia

Group Type OTHER

UPnRIDE Powered Wheelchair

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

UPnRIDE Robotics Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabi Zeilig, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine,

Locations

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The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Shany Kheifets-Zohar, Bsc.

Role: CONTACT

Phone: 972-4-6110061

Email: [email protected]

Facility Contacts

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Amihai Gottlieb

Role: primary

Other Identifiers

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UPNRIDE-UR-SF-01

Identifier Type: -

Identifier Source: org_study_id