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Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
full-immersive VRapeutic software gaming technology
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Down syndrome DS, Virtual Reality VR

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Effect of fully immersive VR + school regular activities on cognitive functions of Down children

Effect of school regular activities on cognitive functions of down children

Arm Description

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.

Children in this group will practice their regular activities of school and daily living (receive no treatment).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 14, 2023
Last Updated
April 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05849818
Brief Title
Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
Official Title
Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down syndrome DS, Virtual Reality VR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be used
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effect of fully immersive VR + school regular activities on cognitive functions of Down children
Arm Type
Experimental
Arm Description
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.
Arm Title
Effect of school regular activities on cognitive functions of down children
Arm Type
No Intervention
Arm Description
Children in this group will practice their regular activities of school and daily living (receive no treatment).
Intervention Type
Device
Intervention Name(s)
full-immersive VRapeutic software gaming technology
Other Intervention Name(s)
VRapeutic software gaming technology
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of change of cognitive function by using the rehacom device
Description
Assessing the change of the cognitive function By using the Rehacom Device within two months
Time Frame
up to two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Eltohamy, Professor
Phone
00201001662350
First Name & Middle Initial & Last Name or Official Title & Degree
maya galal, lecturer
Phone
00201002631238
Email
maya.galal@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Eltohamy, professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
12511
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

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