- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03503955
Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases
Investigation of the Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bakırköy
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Istanbul, Bakırköy, Turkey, 34740
- IstanbulU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
fine motor skills activities and 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
|
activities that stimulate finger movements such as holding, reaching, catching, writing, and strengthening muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from Baseline and to the 2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ela Tarakcı, Assoc. Prof., Istanbul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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