Feasibility of the Portable YouGrabber System | NCT02368223

Studies
Feasibility of the Portable YouGrabber System

NCT02368223

Sponsor

University Children's Hospital, Zurich

Status

Completed

Last Update Posted

Jul 24, 2015Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Cerebral Palsy
Stroke
Traumatic Brain Injury
Meningomyelocele
Central Nervous System Diseases

Interventions

YouGrabber

Countries

Switzerland

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

Jul 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

Oct 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Feb 13, 2015

First Submission Date that Met QC Criteria

Feb 20, 2015

First Posted Date

Feb 23, 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

Jul 23, 2015

Last Update Posted Date

Jul 24, 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 aim of the study is to determine the feasibility of the portable version of the YouGrabber® system in children with central motor disorders.

Detailed Description

In a feasibility trial with the portable version of the YouGrabber® system it will be determined if the technique and equipment are ready to be used in a home setting where children with central motor disorders train with assistance of caregivers but without a therapist. Furthermore, it will be examined if children and adolescents with central motor disorders accept this home-based system and if they are motivated for using it.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
YouGrabber training	Experimental	Home-based YouGrabber training	Device: YouGrabber

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YouGrabber	Device	2 weeks of home-based therapy with a virtual-reality enhanced upper limb training system	YouGrabber training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
User satisfaction (Questionnaire about usability, motivation, general opinion)	Questionnaire about usability, motivation, general opinion	week 2

Secondary Outcomes

Measure	Description	Time Frame
Device usage (Total time of exercise per week; time of training session)	Total time of exercise per week; time of training session	week 2
Error rate (Error prone games; application problems as a home-based system)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Central motor disorders
Ability to sit in an upright position for 45 minutes

Exclusion Criteria:

Manual Ability Classification Scale (MACS) V
Severe visual or auditory impairments
Severe photosensitive epilepsy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Corinna Gerber, MSc	University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis		Affoltern am Albis		CH-8910	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27008504	Derived	Gerber CN, Kunz B, van Hedel HJ. Preparing a neuropediatric upper limb exergame rehabilitation system for home-use: a feasibility study. J Neuroeng Rehabil. 2016 Mar 23;13:33. doi: 10.1186/s12984-016-0141-x.

ID	Term
D002547	Cerebral Palsy
D020521	Stroke
D000070642	Brain Injuries, Traumatic
D008591	Meningomyelocele
D002493	Central Nervous System Diseases

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D009422	Nervous System Diseases
D002561	Cerebrovascular Disorders