Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

NCT ID: NCT05849818

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Down Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be used
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

full-immersive VRapeutic software gaming technology

Intervention Type DEVICE

* 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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VRapeutic software gaming technology

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayman Kamal Elboraey

Professor of Pediatric physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amira Eltohamy, professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Giza, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amira Eltohamy, Professor

Role: CONTACT

00201001662350

maya galal, lecturer

Role: CONTACT

00201002631238

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ayman Kamal

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Empathy and Virtual Reality (VR)
NCT07314788 NOT_YET_RECRUITING NA
Virtual Reality Distraction in Pediatric Patients.
NCT06355492 NOT_YET_RECRUITING PHASE4
Home Accidents Training For Parents of CWSN
NCT06839196 NOT_YET_RECRUITING NA