Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 14, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedMay 9, 2023
April 1, 2023
2 months
April 14, 2023
April 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Effect of fully immersive VR + school regular activities on cognitive functions of Down children
EXPERIMENTALChildren 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.
Effect of school regular activities on cognitive functions of down children
NO INTERVENTIONChildren in this group will practice their regular activities of school and daily living (receive no treatment).
Interventions
* 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Giza, 12511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amira Eltohamy, professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatric physical therapy
Study Record Dates
First Submitted
April 14, 2023
First Posted
May 9, 2023
Study Start
May 1, 2023
Primary Completion
July 1, 2023
Study Completion
August 1, 2023
Last Updated
May 9, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share