Performance of the BioGaming Device (YuGo) in the Support... | NCT02373748

Studies
Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation

NCT02373748

Sponsor

BioGaming Ltd.

Status

Completed

Last Update Posted

Jun 4, 2015Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Physical Rehabilitation

Interventions

BioGaming YuGo System

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 17, 2015

First Submission Date that Met QC Criteria

Feb 22, 2015

First Posted Date

Feb 27, 2015Estimated

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

Jun 3, 2015

Last Update Posted Date

Jun 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.

Detailed Description

Not provided

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BioGaming YuGo System	Experimental		Device: BioGaming YuGo System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BioGaming YuGo System	Device	Subjects will perform a customized training program predefined in the BioGaming YuGo system.	BioGaming YuGo System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements.	Activity movements are assessed by independent clinicians.	Baseline procedure

Secondary Outcomes

Measure	Description	Time Frame
Safety - Record of any adverse event	Any adverse event occurring during the baseline procedure will be recorded.	Baseline procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is willing to comply with protocol-specified evaluations
Subject signed informed consent

Exclusion Criteria:

Pregnant or nursing female subjects
Surgical procedures or injuries to the extremities that could potentially affect physical functions
Neurological and/or vestibular disease
Cognitive impairment
Subjects taking any prescribed drugs that could potentially affect physical function and balance

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		Haifa		31096	Israel