Effectiveness of Video Based Games on Upper Extremity Fun... | NCT03503955

Studies
Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases

NCT03503955

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Feb 5, 2025Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Mental Retardation
Upper Extremity

Interventions

Leap-Motion virtual reality games
fine motor skills activities

Countries

Turkey (Türkiye)

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

Apr 2018

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

Dec 13, 2017Actual

Primary Completion Date

Apr 19, 2020Actual

Completion Date

Jul 13, 2020Actual

First Submitted Date

Apr 2, 2018

First Submission Date that Met QC Criteria

Apr 19, 2018

First Posted Date

Apr 20, 2018Actual

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

Feb 2, 2025

Last Update Posted Date

Feb 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

With Leap Motion Controller, virtual reality exercises have been implemented more often since 2014, and this technology has benefited more from upper extremity rehabilitation In literature, there are no publications investigating the effectiveness of virtual reality applications on upper extremity functions in cases of mental retardation with Leap Motion.

We think that virtual reality applications with Leap Motion are effective in fine motor skills and grip strength in cases of mental retardation.

The purpose of our work; To Investigation of the Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases

Detailed Description

For the study group, in addition to fine motor skills activities, 20 min. Leap-Motion virtual reality games, and for the control group only fine motor skill activities will be applied. The study will last 8 weeks, 2 times a week for a total of 16 sessions.The games that Fizyosoft has built on Leap Motion equipment will be played individually and will focus on running hand, wrist and grip movements to improve hand and grip activities of the events. Each game is designed to develop a different hand movement. In this study, CatchaPet and LeapBall of Fizyosoft HandRom products will be used.

"LeapBall," aiming at throwing the ball in the same color as the ball, and Leap Motion sensor games, "CatchaPet," aimed at touching the rabbits out of the holes with repeated wrist flexion / extensional movements, will be preferred by grasping a virtual ball with the fingers of all fingers.

The demographic characteristics of all the cases participating in the study will be recorded.

JEBSON hand function test, Manual Ability Classification System (MACS), 9 Hole Peg Test to measure fine hand skill. JAMAR Hand Dynamometer to measure Hand Grip Force, Pinchmeter to measure finger grip strength. The evaluation will be repeated before and after the treatment.

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

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	fine motor skills activities and Leap-Motion virtual reality games	Other: Leap-Motion virtual reality games
control group	Experimental	fine motor skills activities	Other: fine motor skills activities

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leap-Motion virtual reality games	Other	Games that Fizyosoft has prepared on Leap Motion equipment to improve hand and grip activities will be played individually and will focus on running hand, wrist and grip movements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Jebsen Hand Function Test	The Jebsen Hand Function Test assesses fine motor skills, weighted and non-weighted hand function activities during performance of activities of daily living	Change from Baseline and to the 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

He / she has been diagnosed with mild mental retardation Being between 5 and 18 years of age Ability to adapt to exercises No epileptic epilepsy no cardiac or orthopedic disturbance

Exclusion Criteria:

Being healthy Not be between 5-18 years

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
Ela Tarakcı, Assoc. Prof.	Istanbul University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IstanbulU		Istanbul	Bakırköy	34740	Turkey (Türkiye)

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

Condition Browse Module

MeSH Terms

ID	Term
D008607	Intellectual Disability

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

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Browse Branches

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