NCT03503955

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
Last Updated

February 5, 2025

Status Verified

April 1, 2018

Enrollment Period

2.4 years

First QC Date

April 2, 2018

Last Update Submit

February 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

study group

activities that stimulate finger movements such as holding, reaching, catching, writing, and strengthening muscles

control group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Being healthy Not be between 5-18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IstanbulU

Istanbul, Bakırköy, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ela Tarakcı, Assoc. Prof.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 20, 2018

Study Start

December 13, 2017

Primary Completion

April 19, 2020

Study Completion

July 13, 2020

Last Updated

February 5, 2025

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations