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

Primary Purpose

Mental Retardation, Upper Extremity

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Leap-Motion virtual reality games
fine motor skills activities
Sponsored by
Ela Tarakci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Retardation

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IstanbulURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

fine motor skills activities and Leap-Motion virtual reality games

fine motor skills activities

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 2, 2018
Last Updated
April 19, 2018
Sponsor
Ela Tarakci
Collaborators
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03503955
Brief Title
Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases
Official Title
Investigation of the Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
April 19, 2018 (Actual)
Study Completion Date
July 13, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ela Tarakci
Collaborators
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Retardation, Upper Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
fine motor skills activities and Leap-Motion virtual reality games
Arm Title
control group
Arm Type
Experimental
Arm Description
fine motor skills activities
Intervention Type
Other
Intervention Name(s)
Leap-Motion virtual reality games
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
fine motor skills activities
Intervention Description
activities that stimulate finger movements such as holding, reaching, catching, writing, and strengthening muscles
Primary Outcome Measure Information:
Title
Jebsen Hand Function Test
Description
The Jebsen Hand Function Test assesses fine motor skills, weighted and non-weighted hand function activities during performance of activities of daily living
Time Frame
Change from Baseline and to the 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NEJLA UZUN, PT
Phone
900-507-642-6043
Email
fizyoterapist_nejla@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ela Tarakcı, Assoc. Prof.
Phone
900-542-217-5730
Email
fztela@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ela Tarakcı, Assoc. Prof.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IstanbulU
City
Istanbul
State/Province
Bakırköy
ZIP/Postal Code
34740
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nejla Uzun, PT
Phone
900-507-642-6043
Email
fizyoterapist_nejla@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ela Tarakcı
Phone
900-542-217-5730
Email
fztela@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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