Down SyndromeNCT05849818
Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
A study testing full-immersive VRapeutic software gaming technology in people with Down Syndrome, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- full-immersive VRapeutic software gaming technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Amira Eltohamy, Professor contact
About this study
The purpose of the study is to identify the effect of fully-immersive virtual reality technology on cognitive functions of children with Down syndrome
Read the 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
- Conditions
- Down Syndrome
- Being tested
- full-immersive VRapeutic software gaming technology
- Keywords
- Down syndrome DS, Virtual Reality VR
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full-immersive VRapeutic software gaming technologyDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Effect of fully immersive VR + school regular activities on cognitive functions of Down children | Experimental | 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. Receives: Device: full-immersive VRapeutic software gaming technology |
| Effect of school regular activities on cognitive functions of down children | No intervention | Children in this group will practice their regular activities of school and daily living (receive no treatment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study startMay 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be used
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Kamal Elboraey, Cairo University
- Investigators
- Amira Eltohamy, professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849818
- Sponsor's protocol ID
- Ayman Kamal
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05849818
- Acronym / sponsor ID
- Ayman Kamal
- Conditions
- Down Syndrome
- Keywords
- Down syndrome DS, Virtual Reality VR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be used
| Arm | Type | Receives |
|---|---|---|
| Effect of fully immersive VR + school regular activities on cognitive functions of Down children | Experimental | Device: full-immersive VRapeutic software gaming technologyChildren 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 intervention | –Children in this group will practice their regular activities of school and daily living (receive no treatment). |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full-immersive VRapeutic software gaming technologyAlso: 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 | Device | Effect of fully immersive VR + school regular activities on cognitive functions of Down children |
Primary outcome
Rate of change of cognitive function by using the rehacom device
Time frame: up to two months
Assessing the change of the cognitive function By using the Rehacom Device within two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira Eltohamy, Professor contact
Amira Eltohamy, professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full-immersive VRapeutic software gaming technology in people with Down Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Eltohamy, Professor (00201001662350), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change of cognitive function by using the rehacom device (time frame: up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.