Down SyndromeNCT06943261
Effects of Task-oriented Training on Visual-motor Integration and Upper Limb Function in Children With Down Syndrome
A study testing task oriented training and conventional therapy in people with Down Syndrome, run by Riphah International University.
Trial summary
The condition known as Down Syndrome (DS) is caused by trisomy 21, or the presence of an extra copy of chromosome 21. DS is the most common survivable autosomal aneuploidy and one of the genetically complicated problem compatible with post-term human survival. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- task oriented training and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 16 Jun 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Diagnosed down syndrome patient
- Both male and female
- Age range 5 to 12
- Children who has poor VM skills
Who cannot join
- • Sever intellectual disability
- Previous participation in similar interventions
- Uncontrolled medical or psychiatric conditions
- Low communication skills
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
The condition known as Down Syndrome (DS) is caused by trisomy 21, or the presence of an extra copy of chromosome 21. DS is the most common survivable autosomal aneuploidy and one of the genetically complicated problem compatible with post-term human survival. Based on current birth prevalence, the prevalence of DS is around 25%-40%. It is one of the most prevalent disease. Visual-motor integration difficulties are common in children with DS, which affects their capacity to synchronize hand movements with vision. This may have an impact on ADLS like writing, eating, grooming. Both delays in motor skills and visual processing might cause difficulties in this domain.
This study will be a randomized controlled trial conducted in spectrum clinic. This study will be completed in time duration of 10 months after approval of synopsis. Non-probability convenience sampling technique will be used and 28 participants will be recruited in study after randomization. Informed consent will be taken from gradians then, the subjects will be divided into two groups and the Group A (Experimental group) will receive task-oriented training 3 times a week which focus on exercises that improve UL function and visual motor coordination and Group B (Control group) will receive general physiotherapy plan and game-based interventions. Poor visual motor skills are one of the inclusion criteria, but significant intellectual disability, prior involvement in related interventions, and untreated medical or psychological conditions are among the exclusion criteria. The data will be assessed at the baseline and after 8th week of treatment. After data collection data will be analyzed by using SPSS version 23.
- Conditions
- Down Syndrome
- Being tested
- task oriented training, conventional therapy
- Keywords
- Down's syndrome, Visual motor integration, Task-oriented training, Upper limb function
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task oriented trainingOther
The 8-week intervention program targets fine motor and functional play skills in children through progressive weekly activities. Week 1 focuses on eye-hand coordination (e.g., stacking blocks, bead stringing), followed by grasp and release control in Week 2 (e.g., object transfer tasks). Week 3 enhances reaching and precision (e.g., targeting and catching), while Week 4 develops bilateral coordination (e.g., buttoning, tearing paper). Week 5 works on visual-motor planning (e.g., drawing, tracing), and Week 6 encourages daily functional play (e.g., pouring, pretend cooking). Week 7 combines skills (e.g., dressing a doll, coin placement), and Week 8 consolidates learning through review and practice of previous tasks.
conventional therapyOther
The control group will receive standard physical therapy consisting of general exercises aimed at improving overall strength, flexibility, and gross motor skills, without specifically targeting visual-motor integration or fine motor skills. Sessions will also include non-specific recreational activities such as free play or unstructured tasks. The intervention will be conducted three times per week, with each session lasting 45-60 minutes, over a total duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: task oriented training | Experimental | experimental group will receive session of 30 to 45 min of 3 times a week for eight weeks Receives: Other: task oriented training; Other: conventional therapy |
| control group : conventional therapy and game based interventions | Active comparator | control group will receive session of 30 to 45 min of 3 times a week for eight weeks Receives: Other: task oriented training; Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebson Taylor Hand Function Test (JTHFT)
) is a widely used tool for assessing upper limb function in individuals with conditions such as Down syndrome. It evaluates various hand activities, including grasp, manipulation, and coordination, providing valuable insights into the individual's functional abilities and limitations.The Length of the test is 15-45 minutes to complete the JTHFT. JTHFT had moderate to high test-retest reliability and excellent inter-rater reliability (r=0.84 and 0.85, P<0.05) with absent practice effect (P<0.05)
Measured: baseline, 4th week,8th week
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)
it is a widely used assessment tool designed to evaluate visual-motor integration skills across various age groups.It takes almost 10 to 15 min to complete the task.The test retest reliability is excellent (0.84-0.88). The Interrater reliability is (0.90-0.98)
Measured: baseline, 4th week,8th 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 Jun 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.
- 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 controlled trial performed in which 28 Down Syndrome children with the age of 6-12 age, will be taken randomly after screening and meeting inclusion criteria. children will be divide in to two groups. Group A (experimental group) will receive task-oriented training of 8 weeks for 30-45 min 3 days a week and (control group) will receive a conventional therapy and game based interventions of 8 weeks for 30-45 min 3 days a week. pre values were take from week 1 and then on week 4 mid values of intervention will be taken and at the end post values of interventions will be taken to measure the effects of both therapies
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sajal Waheed, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943261
- Sponsor's protocol ID
- REC/RCR/AHS/25/ Sajal Waheed
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thant AA, Wanpen S, Nualnetr N, Puntumetakul R, Chatchawan U, Hla KM, Khin MT. Effects of task-oriented training on upper extremity functional performance in patients with sub-acute stroke: a randomized controlled trial. J Phys Ther Sci. 2019 Jan;31(1):82-87. doi: 10.1589/jpts.31.82. Epub 2019 Jan 29.
PubMed 30774211
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 Task-oriented Training on Visual-motor Integration and Upper Limb Function in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06943261
- Acronym / sponsor ID
- REC/RCR/AHS/25/ Sajal Waheed
- Conditions
- Down Syndrome
- Keywords
- Down's syndrome, Visual motor integration, Task-oriented training, Upper limb function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 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 Jun 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.
The condition known as Down Syndrome (DS) is caused by trisomy 21, or the presence of an extra copy of chromosome 21. DS is the most common survivable autosomal aneuploidy and one of the genetically complicated problem compatible with post-term human survival. Based on current birth prevalence, the prevalence of DS is around 25%-40%. It is one of the most prevalent disease. Visual-motor integration difficulties are common in children with DS, which affects their capacity to synchronize hand movements with vision. This may have an impact on ADLS like writing, eating, grooming. Both delays in motor skills and visual processing might cause difficulties in this domain.
This study will be a randomized controlled trial conducted in spectrum clinic. This study will be completed in time duration of 10 months after approval of synopsis. Non-probability convenience sampling technique will be used and 28 participants will be recruited in study after randomization. Informed consent will be taken from gradians then, the subjects will be divided into two groups and the Group A (Experimental group) will receive task-oriented training 3 times a week which focus on exercises that improve UL function and visual motor coordination and Group B (Control group) will receive general physiotherapy plan and game-based interventions. Poor visual motor skills are one of the inclusion criteria, but significant intellectual disability, prior involvement in related interventions, and untreated medical or psychological conditions are among the exclusion criteria. The data will be assessed at the baseline and after 8th week of treatment. After data collection data will be analyzed by using SPSS version 23.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Randomized controlled trial performed in which 28 Down Syndrome children with the age of 6-12 age, will be taken randomly after screening and meeting inclusion criteria. children will be divide in to two groups. Group A (experimental group) will receive task-oriented training of 8 weeks for 30-45 min 3 days a week and (control group) will receive a conventional therapy and game based interventions of 8 weeks for 30-45 min 3 days a week. pre values were take from week 1 and then on week 4 mid values of intervention will be taken and at the end post values of interventions will be taken to measure the effects of both therapies
| Arm | Type | Receives |
|---|---|---|
| Experimental group: task oriented training | Experimental | Other: task oriented training, Other: conventional therapyexperimental group will receive session of 30 to 45 min of 3 times a week for eight weeks |
| control group : conventional therapy and game based interventions | Active comparator | Other: task oriented training, Other: conventional therapycontrol group will receive session of 30 to 45 min of 3 times a week for eight weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Diagnosed down syndrome patient
Key exclusion criteria (4 listed)
- • Sever intellectual disability
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 |
|---|---|---|
| task oriented trainingThe 8-week intervention program targets fine motor and functional play skills in children through progressive weekly activities. Week 1 focuses on eye-hand coordination (e.g., stacking blocks, bead stringing), followed by grasp and release control in Week 2 (e.g., object transfer tasks). Week 3 enhances reaching and precision (e.g., targeting and catching), while Week 4 develops bilateral coordination (e.g., buttoning, tearing paper). Week 5 works on visual-motor planning (e.g., drawing, tracing), and Week 6 encourages daily functional play (e.g., pouring, pretend cooking). Week 7 combines skills (e.g., dressing a doll, coin placement), and Week 8 consolidates learning through review and practice of previous tasks. | Other | Experimental group: task oriented training, control group : conventional therapy and game based interventions |
| conventional therapyThe control group will receive standard physical therapy consisting of general exercises aimed at improving overall strength, flexibility, and gross motor skills, without specifically targeting visual-motor integration or fine motor skills. Sessions will also include non-specific recreational activities such as free play or unstructured tasks. The intervention will be conducted three times per week, with each session lasting 45-60 minutes, over a total duration of 8 weeks. | Other | Experimental group: task oriented training, control group : conventional therapy and game based interventions |
Primary outcome
Jebson Taylor Hand Function Test (JTHFT)
Time frame: baseline, 4th week,8th week
) is a widely used tool for assessing upper limb function in individuals with conditions such as Down syndrome. It evaluates various hand activities, including grasp, manipulation, and coordination, providing valuable insights into the individual's functional abilities and limitations.The Length of the test is 15-45 minutes to complete the JTHFT. JTHFT had moderate to high test-retest reliability and excellent inter-rater reliability (r=0.84 and 0.85, P<0.05) with absent practice effect (P<0.05)
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)
Time frame: baseline, 4th week,8th week
it is a widely used assessment tool designed to evaluate visual-motor integration skills across various age groups.It takes almost 10 to 15 min to complete the task.The test retest reliability is excellent (0.84-0.88). The Interrater reliability is (0.90-0.98)
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.
- Background: PubMed 30774211Thant AA, Wanpen S, Nualnetr N, Puntumetakul R, Chatchawan U, Hla KM, Khin MT. Effects of task-oriented training on upper extremity functional performance in patients with sub-acute stroke: a randomized controlled trial. J Phys Ther Sci. 2019 Jan;31(1):82-87. doi: 10.1589/jpts.31.82. Epub 2019 Jan 29.
- Individual participant dataSharing planned: No
Related trials for Down Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
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.
Sajal Waheed, MS-PT principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing task oriented training and conventional therapy 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 4 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: 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?
Jebson Taylor Hand Function Test (JTHFT) (time frame: baseline, 4th week,8th week). 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 NCT06943261, 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.