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NCT05849818 Clinical Trial

Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

Down Syndrome Clinical Trial

Official title:
Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05849818
Other study ID # Ayman Kamal
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2023
Est. completion date August 2023

Study information
Verified date April 2023
Source Cairo University
Contact Amira Eltohamy, Professor
Phone 00201001662350
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to identify the effect of fully-immersive virtual reality technology on cognitive functions of children with Down syndrome

Description:

Intellectual disability is recognized as one of the most prominent features of DS which is the most common genetic cause of intellectual disability. Cognitive functioning often changes across the lifespan and is moderated by several comorbid factors such as sensory impairments, seizures, autism, sleep disruption, and other medical and psychiatric conditions (Grieco et al., 2015). There is encouraging evidence supporting the use of non-immersive virtual environments to provide useful learning, rehabilitation, and leisure experiences for people with intellectual disabilities. Therefore, immersive VR applications may also be an effective way to improve motivation and engagement for children with DS in learning settings (Michalski et al., 2022). Therefore, this study aims to investigate the effect of full-immersive VRapeutic software gaming technology on cognitive functions of children with Down syndrome

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date August 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - Diagnosed with Down Syndrome Age from 6-10 years Both Genders will be included IQ Ranges from 50-69(mild intellectual disability) they will be able to understand the instructions able to walk independently Exclusion Criteria: - Significant Visual or Hearing problems Significant mental or psychological problems that interfere with understanding instructions musculoskeletal problems or fixed deformities in upper or lower limbs Current hospitalization for urgent Medical reasons

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• full-immersive VRapeutic software gaming technology
Children of the study group will receive VR training sessions 3 times per week for 8 successive weeks. Viblio VRapeutic fully immersive game will be used. Manual instructions of the game will be followed and features of the game will be customized. The child instructed to put back a pile of books on the floor into their shelves. Level II of the game we will use audio visual distractors , repeated parrot sound and the child is required to order the books by colors Level III distracting tasks during book ordering The complexity of the game depend on task duration, number of books and the nature of distractors

Locations
Country Name City State
Egypt Cairo University Giza

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of change of cognitive function by using the rehacom device Assessing the change of the cognitive function By using the Rehacom Device within two months up to two months
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