Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome
• Intervention / Treatment: Device: full-immersive VRapeutic software gaming technology

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amira Eltohamy, Professor; Phone Number: 00201001662350
• Study Contact Backup: Name: maya galal, lecturer; Phone Number: 00201002631238; Email: maya.galal@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12511
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effect of fully immersive VR + school regular activities on cognitive functions of Down children; Children in this group will practice the same activities as control group in addition to virtual reality session using fully-immersive VRapeutic software gaming technology (Viblio module)for 20 min/3sessions/week for 8 weeks.	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; Other Names: VRapeutic software gaming technology
No Intervention: Effect of school regular activities on cognitive functions of down children; Children in this group will practice their regular activities of school and daily living (receive no treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amira Eltohamy, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Down syndrome DS; Virtual Reality VR
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: Ayman Kamal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No