NCT06943261

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 17, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Down's syndromeVisual motor integrationTask-oriented trainingUpper limb function

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    baseline, 4th week,8th week

Study Arms (2)

Experimental group: task oriented training

EXPERIMENTAL

experimental group will receive session of 30 to 45 min of 3 times a week for eight weeks

Other: task oriented trainingOther: 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

Other: task oriented trainingOther: conventional therapy

Interventions

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.

Experimental group: task oriented trainingcontrol group : conventional therapy and game based interventions

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.

Experimental group: task oriented trainingcontrol group : conventional therapy and game based interventions

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed down syndrome patient
  • Both male and female
  • Age range 5 to 12
  • Children who has poor VM skills

You may not qualify if:

  • Sever intellectual disability
  • Previous participation in similar interventions
  • Uncontrolled medical or psychiatric conditions
  • Low communication skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30774211BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Sajal Waheed, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed,, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will get separated treatment protocol and possible effects will be put to mask the both group about the treatment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 15, 2025

Primary Completion

April 15, 2025

Study Completion

June 16, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share