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Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05849818
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
3
Anticipated Duration (Months)
9.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: full-immersive VRapeutic software gaming technology
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be usedA prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be used
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. Rate of change of cognitive function by using the rehacom device [up to two months]

      Assessing the change of the cognitive function By using the Rehacom Device within two months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Giza Egypt 12511

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Amira Eltohamy, professor, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayman Kamal Elboraey, Professor of Pediatric physical therapy, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05849818
    Other Study ID Numbers:
    • Ayman Kamal
    First Posted:
    May 9, 2023
    Last Update Posted:
    May 9, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayman Kamal Elboraey, Professor of Pediatric physical therapy, Cairo University
    Down syndrome DS
    Virtual Reality VR
    Additional relevant MeSH terms:
    Down Syndrome
    Syndrome

    Study Results

    No Results Posted as of May 9, 2023