UPNRIDE Powered Wheelchair for Individuals With Walking I... | NCT02983955

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

NCT02983955

Sponsor

UPnRIDE Robotics Ltd.

Status

Unknown status

Last Update Posted

Dec 6, 2016Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Spinal Cord Injury Cervical

Interventions

UPnRIDE Powered Wheelchair

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Dec 1, 2016

First Posted Date

Dec 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2016

Last Update Posted Date

Dec 6, 2016Estimated

Name	Class
Sheba Medical Center	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCI with Tetraplegia	Other		Device: UPnRIDE Powered Wheelchair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UPnRIDE Powered Wheelchair	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		Through study completion, an average of 3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shany Kheifets-Zohar, Bsc.	Contact	972-4-6110061		shany@upnride.com

Overall Officials

Name	Affiliation	Role
Gabi Zeilig, MD	Department of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine,	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chaim Sheba Medical Center	Recruiting	Ramat Gan			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided