- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943261
Effects of Task-oriented Training on Visual-motor Integration and Upper Limb Function in Children With Down Syndrome
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed,, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Diagnosed down syndrome patient
- Both male and female
- Age range 5 to 12
- Children who has poor VM skills
Exclusion Criteria:
• Sever intellectual disability
- Previous participation in similar interventions
- Uncontrolled medical or psychiatric conditions
- Low communication skills
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group: task oriented training
experimental group will receive session of 30 to 45 min of 3 times a week for eight weeks
|
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.
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.
|
|
Active Comparator: control group : conventional therapy and game based interventions
control group will receive session of 30 to 45 min of 3 times a week for eight weeks
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
baseline, 4th week,8th week
|
|
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)
|
baseline, 4th week,8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sajal Waheed, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR/AHS/25/ Sajal Waheed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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