Down SyndromeNCT05978778
Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.
A study testing wii sports game and pre-hand writing skills in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is most common genetic mental disability that affects children physically, mentally and functionally. It occurs due to an extra copy of chromosome 21. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- wii sports game and pre-hand writing skills
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 27 May 2023to 15 Sep 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5 to 14 years.
- Both male and female patient diagnosed with down syndrome.
- Able to understand and follow verbal command.
- Down syndrome children with pre-hand writing skills are not good.
- Difficulty in fine motor skills.
Who cannot join
- Patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss.
- Musculoskeletal and mobility disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is most common genetic mental disability that affects children physically, mentally and functionally. It occurs due to an extra copy of chromosome 21. It involves a slightly flattened facial profile, low muscle tone upward-slanted eyes, and ligamentous laxity. Central hypotonia, mental retardation and short stature are very common features of children with down's syndrome. Children with down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills and , under-development of fine motor skills. Active video gaming used different games that involve interactive session that can enhance cortical recognition, motor learning and functional profile of children with DS. The objective of this study is to determine the effects of active video gaming on pre-hand writing skills of children with down's syndrome. This will be a RCT(Randomized Controlled Trial).The sample size was 18 and the study design was a case-control trial. The inclusion criteria are children with down syndrome age 6 to 12 years both male and female patients are randomly selected and children with poor pre-hand writing skills. And the exclusion criteria for this study is children with any other neurological condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and hearing loss. Two groups were randomly assigned and equally divided patients into each group. Group A received pre-handwriting skills, like tracing alphabets and numbers, scribbling, coloring, painting, and group B received active video gaming and prehandwriting skills. For measuring each group developmental coordination
disorder questionnaire tool is used. The session will be taken 30 mins thrice a week for (8consecutive weeks). Data collected from different centers, Raising sun institute of special education. Autism resource center Lahore. SPSS for Windows software, version 25 will be used to analyze the data using statistical Significance p=0.05. The Shapiro-Wilk test will be used to check the normality of data. Keywords: Active video gaming, Down syndrome, Computer game, Fine motor skills, Pre-hand writing skills, Virtual reality gaming.
Read the detailed description
To determine the effects of active video gaming on pre-hand writing skills of children with down syndrome.
- Conditions
- Down Syndrome
- Being tested
- wii sports game, pre-hand writing skills
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wii sports gameDevice
Also called video gaming
wii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote
pre-hand writing skillsOther
pre-hand writing skills
| Study group | Role | What they receive |
|---|---|---|
| controlled group | Other | Nine children will be randomly allocated to control group who receive only pre-hand writing skills. Receives: Other: pre-hand writing skills |
| Experimental group | Experimental | Nine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills. Receives: Device: wii sports game; Other: pre-hand writing skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre handwriting skills syndrome.
bilateral hand use will determine by box and ball test children with down syndrome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start27 May 2023
- Primary completion31 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Effects of active video gaming on pre-handwriting skills of children with down's syndrome.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nageen Zahra, ms, Principal investigator, Ripha International Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978778
- Sponsor's protocol ID
- REC/RCR&AHS/23/0722
- Status last verified
- Nov 2023
- First submitted
- 31 Jul 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.
- ClinicalTrials.gov ID
- NCT05978778
- Acronym / sponsor ID
- REC/RCR&AHS/23/0722
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 7 Aug 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.
Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is most common genetic mental disability that affects children physically, mentally and functionally. It occurs due to an extra copy of chromosome 21. It involves a slightly flattened facial profile, low muscle tone upward-slanted eyes, and ligamentous laxity. Central hypotonia, mental retardation and short stature are very common features of children with down's syndrome. Children with down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills and , under-development of fine motor skills. Active video gaming used different games that involve interactive session that can enhance cortical recognition, motor learning and functional profile of children with DS. The objective of this study is to determine the effects of active video gaming on pre-hand writing skills of children with down's syndrome. This will be a RCT(Randomized Controlled Trial).The sample size was 18 and the study design was a case-control trial. The inclusion criteria are children with down syndrome age 6 to 12 years both male and female patients are randomly selected and children with poor pre-hand writing skills. And the exclusion criteria for this study is children with any other neurological condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and hearing loss. Two groups were randomly assigned and equally divided patients into each group. Group A received pre-handwriting skills, like tracing alphabets and numbers, scribbling, coloring, painting, and group B received active video gaming and prehandwriting skills. For measuring each group developmental coordination
disorder questionnaire tool is used. The session will be taken 30 mins thrice a week for (8consecutive weeks). Data collected from different centers, Raising sun institute of special education. Autism resource center Lahore. SPSS for Windows software, version 25 will be used to analyze the data using statistical Significance p=0.05. The Shapiro-Wilk test will be used to check the normality of data. Keywords: Active video gaming, Down syndrome, Computer game, Fine motor skills, Pre-hand writing skills, Virtual reality gaming.
Detailed description
To determine the effects of active video gaming on pre-hand writing skills of children with down syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Effects of active video gaming on pre-handwriting skills of children with down's syndrome.
| Arm | Type | Receives |
|---|---|---|
| controlled group | Other | Other: pre-hand writing skillsNine children will be randomly allocated to control group who receive only pre-hand writing skills. |
| Experimental group | Experimental | Device: wii sports game, Other: pre-hand writing skillsNine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 5 to 14 years.
- Both male and female patient diagnosed with down syndrome.
- Able to understand and follow verbal command.
- Down syndrome children with pre-hand writing skills are not good.
- Difficulty in fine motor skills.
Key exclusion criteria (2 listed)
- Patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss.
- Musculoskeletal and mobility disorder.
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 |
|---|---|---|
| wii sports gameAlso: video gamingwii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote | Device | Experimental group |
| pre-hand writing skillspre-hand writing skills | Other | Experimental group, controlled group |
Primary outcome
pre handwriting skills syndrome.
Time frame: 6 months
bilateral hand use will determine by box and ball test children with down syndrome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- BackgroundO'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.
- Individual participant dataSharing planned: No
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Down Syndrome
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.
Nageen Zahra, ms principal investigator
Ripha International Univerity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wii sports game and pre-hand writing skills in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 13 Nov 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pre handwriting skills syndrome. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05978778, which also lists 1 linked publication.
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 13 Nov 2023.