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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503955
Recruitment Status : Unknown
Verified April 2018 by Ela Tarakci, Istanbul University.
Recruitment status was:  Recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Istanbul University
Information provided by (Responsible Party):
Ela Tarakci, Istanbul University

Study Description
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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


Condition or disease Intervention/treatment Phase
Mental Retardation Upper Extremity Other: Leap-Motion virtual reality games Other: fine motor skills activities Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation of the Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : April 19, 2018
Estimated Study Completion Date : July 13, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: study group
fine motor skills activities and Leap-Motion virtual reality games
 Other: Leap-Motion virtual reality games
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
Experimental: control group
fine motor skills activities
 Other: fine motor skills activities
activities that stimulate finger movements such as holding, reaching, catching, writing, and strengthening muscles


Outcome Measures
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Primary Outcome Measures :
  1. Jebsen Hand Function Test [ Time Frame: Change from Baseline and to the 2 months ]
    The Jebsen Hand Function Test assesses fine motor skills, weighted and non-weighted hand function activities during performance of activities of daily living


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503955


Contacts
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Contact: NEJLA UZUN, PT 900-507-642-6043 fizyoterapist_nejla@hotmail.com
Contact: Ela Tarakcı, Assoc. Prof. 900-542-217-5730 fztela@hotmail.com

Locations
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Turkey
IstanbulU Recruiting
Istanbul, Bakırköy, Turkey, 34740
Contact: Nejla Uzun, PT    900-507-642-6043    fizyoterapist_nejla@hotmail.com   
Contact: Ela Tarakcı    900-542-217-5730    fztela@hotmail.com   
Sponsors and Collaborators
Ela Tarakci
Istanbul University
Investigators
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Principal Investigator: Ela Tarakcı, Assoc. Prof. Istanbul University
More Information
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Responsible Party: Ela Tarakci, Assoc. Prof. Ela TARAKCI, PT, PhD, Istanbul University
ClinicalTrials.gov Identifier: NCT03503955    
Other Study ID Numbers: 10840098
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders