Down SyndromeNCT06943352
Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome
A study testing Sensory Bins and Drawing and Painting in people with Down Syndrome, run by Riphah International University.
Trial summary
Down Syndrome is a genetic condition in which a patient has an extra chromosome which is a copy of chromosome 21. It causes physical, cognitive, and behavioral symptoms. The person has difficulty with normal life activities. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Sensory Bins and Drawing and Painting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with moderate level of mental retardation who are able to follow commands
Who cannot join
- • Children with other musculoskeletal and neurological issues.
- Children with down syndrome but also have complications such as epilepsy, congenital heart condition.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome Children
Down Syndrome is a genetic condition in which a patient has an extra chromosome which is a copy of chromosome 21. It causes physical, cognitive, and behavioral symptoms. The person has difficulty with normal life activities. This study evaluates the effect of interactive sensory play on coordinated hand movements or manual dexterity in children with Down Syndrome. Down syndrome is one of the most common birth defects and causes impairments in the body. The children diagnosed with Down syndrome need great deal of therapies in early childhood so that can live a better life. The objective of this study is to assess the effects of interactive sensory play on manual dexterity in Down syndrome children.
The study design will be a Randomized Controlled Trial. The study setting will be Tehsil Headquater hospital Sadiqabad. The study duration will be 10 months after the approval of the synopsis. The Sample Size will be 22 which is calculated by epitools. The sampling technique will be a Non-probability convenient sampling technique. Children who are diagnosed with Down Syndrome will be included. Children with other musculoskeletal and neurological issues will be excluded. Data Collection Tools will be Box and Block test and Pediatric Evaluation of Disability Inventory. Identification and recruitment of the participants with Down syndrome will be done. Participants will be selected through lottery for both groups. Group 1 will use Interactive Sensory play and Group 2 will use Free Play as intervention. The assessor will be blind. The data will be analyzed using SPSS 23.
- Conditions
- Down Syndrome
- Being tested
- Sensory Bins, Drawing and Painting
- Keywords
- Interactive Sensory play, Manual Dexterity, Free Play
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory BinsOther
The sensory bin is a basket filled with different objects of different shapes, sizes, and textures.
Drawing and PaintingOther
Colored pencils and watercolors will be used.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Sensory play with Free Play Group | Experimental | Participants of this group will play in a group with sensory bins with other children. The sensory bin is a basket filled with different objects of different shapes, sizes, and textures. The intervention will help children interact with others in society and for improving manual dexterity. The children play in group and alone also for this group.
According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The free play will be given for 15 minutes and interactive sensory play will be given for 30 minutes. The interventions will be given for 45 minutes in each session. Receives: Other: Sensory Bins; Other: Drawing and Painting |
| Free Play Group | Active comparator | Drawing and painting are involved in free play. Participants of this group will play alone. The participants will draw or paint for improving manual dexterity. According to the FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session. Receives: Other: Drawing and Painting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block test
This test is used to measure manual dexterity. This test is simple, cheap and quick. The test can be used for different populations to assess the coordinated movements of the hands. The test-retest reliability on more weak hand is 0.98 and the less weak hand is 0.93.It has good convergent validity as the value is 0.80.
Measured: At the start as baseline data. Again at 6th week and then finally at 12th week.
• Pediatric Evaluation of Disability Inventory
This is an interviewing tool to assess the independence of the patients to perform different activities using their hands. The reliability that was seen was ranging from 0.18 to 0.94. The value of construct validity was seen to be ranging from 0.64-0.95.
Measured: At the start as baseline data. Again at 6th week and then finally at 12th week.
Nine-Hole Peg Test
This test is used to assess manual dexterity. This test is easy, simple and quick. This test assess coordinated movements of hands. This test consists of a board with nine holes and square boxes or pegs which are inserted into the holes by the participants. This test can be used for assessment in every population. It has excellent interrater reliability which is equal to 0.75 to 0.99. It has excellent convergent validity that is equal to 0.82.
Measured: At the start as baseline data. Again at 6th week and then finally at 12th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion16 Jul 2025 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial will be performed. Participants of this group will play in a group with sensory bins with other children. The intervention will help children interact with others in society and for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. After every 2 weeks, the tasks will be upgraded. The free play will be given for 15 minutes and interactive sensory play will be given for 30 minutes. The interventions will be given for 45 minutes in each session. Drawing and painting are involved in free play. Participants of group will play alone. The participants will draw or paint for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. After every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taiba Hussain, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943352
- Sponsor's protocol ID
- REC/RCR/AHS/25/taiba hussain
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jarusriboonchai P, Meissner JL, Almeida T, Balaam M. Understanding children's free play in primary schools. InProceedings of the 9th International Conference on Communities & Technologies-Transforming Communities 2019 Jun 3 (pp. 178-188).
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome Children
- ClinicalTrials.gov ID
- NCT06943352
- Acronym / sponsor ID
- REC/RCR/AHS/25/taiba hussain
- Conditions
- Down Syndrome
- Keywords
- Interactive Sensory play, Manual Dexterity, Free Play
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 16 Jul 2025 (estimated)
- First posted
- 24 Apr 2025 (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 Syndrome is a genetic condition in which a patient has an extra chromosome which is a copy of chromosome 21. It causes physical, cognitive, and behavioral symptoms. The person has difficulty with normal life activities. This study evaluates the effect of interactive sensory play on coordinated hand movements or manual dexterity in children with Down Syndrome. Down syndrome is one of the most common birth defects and causes impairments in the body. The children diagnosed with Down syndrome need great deal of therapies in early childhood so that can live a better life. The objective of this study is to assess the effects of interactive sensory play on manual dexterity in Down syndrome children.
The study design will be a Randomized Controlled Trial. The study setting will be Tehsil Headquater hospital Sadiqabad. The study duration will be 10 months after the approval of the synopsis. The Sample Size will be 22 which is calculated by epitools. The sampling technique will be a Non-probability convenient sampling technique. Children who are diagnosed with Down Syndrome will be included. Children with other musculoskeletal and neurological issues will be excluded. Data Collection Tools will be Box and Block test and Pediatric Evaluation of Disability Inventory. Identification and recruitment of the participants with Down syndrome will be done. Participants will be selected through lottery for both groups. Group 1 will use Interactive Sensory play and Group 2 will use Free Play as intervention. The assessor will be blind. The data will be analyzed using SPSS 23.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized clinical trial will be performed. Participants of this group will play in a group with sensory bins with other children. The intervention will help children interact with others in society and for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. After every 2 weeks, the tasks will be upgraded. The free play will be given for 15 minutes and interactive sensory play will be given for 30 minutes. The interventions will be given for 45 minutes in each session. Drawing and painting are involved in free play. Participants of group will play alone. The participants will draw or paint for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. After every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session.
| Arm | Type | Receives |
|---|---|---|
| Interactive Sensory play with Free Play Group | Experimental | Other: Sensory Bins, Other: Drawing and PaintingParticipants of this group will play in a group with sensory bins with other children. The sensory bin is a basket filled with different objects of different shapes, sizes, and textures. The intervention will help children interact with others in society and for improving manual dexterity. The children play in group and alone also for this group. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The free play will be given for 15 minutes and interactive sensory play will be given for 30 minutes. The interventions will be given for 45 minutes in each session. |
| Free Play Group | Active comparator | Other: Drawing and PaintingDrawing and painting are involved in free play. Participants of this group will play alone. The participants will draw or paint for improving manual dexterity. According to the FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with moderate level of mental retardation who are able to follow commands
Key exclusion criteria (2 listed)
- • Children with other musculoskeletal and neurological issues.
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 |
|---|---|---|
| Sensory BinsThe sensory bin is a basket filled with different objects of different shapes, sizes, and textures. | Other | Interactive Sensory play with Free Play Group |
| Drawing and PaintingColored pencils and watercolors will be used. | Other | Free Play Group, Interactive Sensory play with Free Play Group |
Primary outcome
Box and Block test
Time frame: At the start as baseline data. Again at 6th week and then finally at 12th week.
This test is used to measure manual dexterity. This test is simple, cheap and quick. The test can be used for different populations to assess the coordinated movements of the hands. The test-retest reliability on more weak hand is 0.98 and the less weak hand is 0.93.It has good convergent validity as the value is 0.80.
• Pediatric Evaluation of Disability Inventory
Time frame: At the start as baseline data. Again at 6th week and then finally at 12th week.
This is an interviewing tool to assess the independence of the patients to perform different activities using their hands. The reliability that was seen was ranging from 0.18 to 0.94. The value of construct validity was seen to be ranging from 0.64-0.95.
Nine-Hole Peg Test
Time frame: At the start as baseline data. Again at 6th week and then finally at 12th week.
This test is used to assess manual dexterity. This test is easy, simple and quick. This test assess coordinated movements of hands. This test consists of a board with nine holes and square boxes or pegs which are inserted into the holes by the participants. This test can be used for assessment in every population. It has excellent interrater reliability which is equal to 0.75 to 0.99. It has excellent convergent validity that is equal to 0.82.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- BackgroundJarusriboonchai P, Meissner JL, Almeida T, Balaam M. Understanding children's free play in primary schools. InProceedings of the 9th International Conference on Communities & Technologies-Transforming Communities 2019 Jun 3 (pp. 178-188).
- Individual participant dataSharing planned: No
Related trials for Down Syndrome
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
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.
Taiba Hussain, MS-PPT principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Bins and Drawing and Painting in people with Down Syndrome, run by Riphah International University.
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 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: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block test (time frame: At the start as baseline data. Again at 6th week and then finally at 12th week.). The study lists 3 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 NCT06943352, 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 24 Apr 2025.