Down SyndromeNCT06531213
Visual Perception Intervention Programmes Impact on Down Syndrome Affiliate Children's Fine Motor and Visual Perception.
A study testing experimental in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
A second copy of chromosome 21 results in Trisomy 21, a genetic disorder commonly referred to as Down syndrome. In addition to physical traits like low muscular tone, upward-slanting eyes, and a flat facial profile, this extra genetic material causes intellectual and developmental difficulties. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 11 Aug 2024
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranged between 6-9 years.
- IQ level mild to moderate (below 40)
Who cannot join
- Heart,
- GIT problems,
- respiratory problems
- and hearing loss.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International university
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Visual Perception Intervention Programme on Fine Motor and Visual Perception in Children With Down Syndrome
A second copy of chromosome 21 results in Trisomy 21, a genetic disorder commonly referred to as Down syndrome. In addition to physical traits like low muscular tone, upward-slanting eyes, and a flat facial profile, this extra genetic material causes intellectual and developmental difficulties. Even though people with Down syndrome may experience a range of health problems, they can lead happy, fulfilling lives if they receive the right support and care. Individual differences in the illness's severity are significant.
There will be a randomized control trial. People with Down syndrome who are five to nine years old will be screened for this study. Adults with Down syndrome and severe ID will not be eligible to participate in this study. Participants will be selected using
Read the detailed description
Conventional physical therapy will be administered to the participants in both groups. Visual perception interventions will be administered to the intervention group, and then standard treatment will follow. For six weeks, there will be three 45-minute treatment sessions per week. Using outcome measure instruments, data will be gathered twice: once at the beginning of the study and again at the end of the six-week course of treatment.
- Conditions
- Down Syndrome
- Being tested
- experimental, controlled
- Keywords
- down syndrome, visual motor skills, Fine motor skills, postural instability
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalOther
Experimental Group: Baseline rehabilitation, Visual Perception Interventions. Home base activities, Baseline Rehabilitation (Strengthing exercise, achieving missing milestones).
Visual Perception Interventions
- Puzzle:Give step-by-step • printable activities • Sudoku. SET, Search Word, Spot it, what is missing, Tic Tac Toe, I Spy
controlledOther
Also called usual control group
Controlled: Baseline rehabilitation. Home-based activities, Baseline Rehabilitation (strengthening exercise, achieving missing milestones).3. Activities Play Dough ( Manipulation) Draw on sketch Cup stacking.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Visual Perception Activities and usual care group Receives: Other: experimental |
| Group B | Experimental | Usual Care group (control) Receives: Other: controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berry Visual Motor Integration
The berry VMI is designed to assess a person's ability to integrate visual and motor skills so that the proper treatment can be provided
Measured: 8weeks
Bruininks oseretsky test
BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation.
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jun 2024
- Primary completion30 Jul 2024
- Study completion11 Aug 2024
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.
- 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
- it will be randomized control trail in which nonprobability convenient sampling will be used .two groups 5 to 9 age will be formed in which participants will randomly divided. Experimental Group: Baseline rehabilitation, Visual Perception Interventions. Control Group: Home-based activities, Baseline Rehabilitation (strengthening exercise, achieving missing milestones).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zohaib Saddiquee, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531213
- Sponsor's protocol ID
- REC/RCR&AHS/23/07101
- Status last verified
- Aug 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahin S, Kose B, Aran OT, Bahadir Agce Z, Kayihan H. The Effects of Virtual Reality on Motor Functions and Daily Life Activities in Unilateral Spastic Cerebral Palsy: A Single-Blind Randomized Controlled Trial. Games Health J. 2020 Feb;9(1):45-52. doi: 10.1089/g4h.2019.0020. Epub 2019 Jul 23.
PubMed 31335174
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visual Perception Intervention Programme on Fine Motor and Visual Perception in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06531213
- Acronym / sponsor ID
- REC/RCR&AHS/23/07101
- Conditions
- Down Syndrome
- Keywords
- down syndrome, visual motor skills, Fine motor skills, postural instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 11 Aug 2024 (actual)
- First posted
- 31 Jul 2024 (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.
A second copy of chromosome 21 results in Trisomy 21, a genetic disorder commonly referred to as Down syndrome. In addition to physical traits like low muscular tone, upward-slanting eyes, and a flat facial profile, this extra genetic material causes intellectual and developmental difficulties. Even though people with Down syndrome may experience a range of health problems, they can lead happy, fulfilling lives if they receive the right support and care. Individual differences in the illness's severity are significant.
There will be a randomized control trial. People with Down syndrome who are five to nine years old will be screened for this study. Adults with Down syndrome and severe ID will not be eligible to participate in this study. Participants will be selected using
Detailed description
Conventional physical therapy will be administered to the participants in both groups. Visual perception interventions will be administered to the intervention group, and then standard treatment will follow. For six weeks, there will be three 45-minute treatment sessions per week. Using outcome measure instruments, data will be gathered twice: once at the beginning of the study and again at the end of the six-week course of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it will be randomized control trail in which nonprobability convenient sampling will be used .two groups 5 to 9 age will be formed in which participants will randomly divided. Experimental Group: Baseline rehabilitation, Visual Perception Interventions. Control Group: Home-based activities, Baseline Rehabilitation (strengthening exercise, achieving missing milestones).
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: experimentalVisual Perception Activities and usual care group |
| Group B | Experimental | Other: controlledUsual Care group (control) |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age ranged between 6-9 years.
- IQ level mild to moderate (below 40)
Key exclusion criteria (4 listed)
- Heart,
- GIT problems,
- respiratory problems
- and hearing loss.
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 |
|---|---|---|
| experimentalExperimental Group: Baseline rehabilitation, Visual Perception Interventions. Home base activities, Baseline Rehabilitation (Strengthing exercise, achieving missing milestones). Visual Perception Interventions • Puzzle:Give step-by-step • printable activities • Sudoku. SET, Search Word, Spot it, what is missing, Tic Tac Toe, I Spy | Other | Group A |
| controlledAlso: usual control groupControlled: Baseline rehabilitation. Home-based activities, Baseline Rehabilitation (strengthening exercise, achieving missing milestones).3. Activities Play Dough ( Manipulation) Draw on sketch Cup stacking. | Other | Group B |
Primary outcome
Berry Visual Motor Integration
Time frame: 8weeks
The berry VMI is designed to assess a person's ability to integrate visual and motor skills so that the proper treatment can be provided
Bruininks oseretsky test
Time frame: 8weeks
BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation.
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 14 Aug 2024.
- Background: PubMed 31335174Sahin S, Kose B, Aran OT, Bahadir Agce Z, Kayihan H. The Effects of Virtual Reality on Motor Functions and Daily Life Activities in Unilateral Spastic Cerebral Palsy: A Single-Blind Randomized Controlled Trial. Games Health J. 2020 Feb;9(1):45-52. doi: 10.1089/g4h.2019.0020. Epub 2019 Jul 23.
- 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.
Zohaib Saddiquee, MS* principal investigator
Riphah International 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 experimental 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 2 inclusion and 4 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 14 Aug 2024. 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?
Berry Visual Motor Integration (time frame: 8weeks). The study lists 2 primary outcomes in all. 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 NCT06531213, 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 14 Aug 2024.