Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06674928

Enrollment

500

Registered

2024-11-05

Start date

2024-07-01

Completion date

2024-10-31

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetics, Life Participation

Keywords

Developmental delay, Life participation, Quality of life, Whole-exome sequencing, Gene, Children Development

Brief summary

The goal of this observational study is to learn the factors affecting the quality of life in children's development. The main hypothesis for this study is: If the level of well-being increases in age, could the quality of life be enhanced in terms of function and participation? Participant will be given assessment every year for five years in total. No intervention will be given during the whole study period.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 15 Years

Healthy volunteers

Inclusion criteria

Normal developing children Inclusion Criteria: * Agreeing in consent * In the age range of 6-15 years old

Exclusion criteria

* Diseases of Central Nervous System * Diseases of Neuromuscular * Nature deficit disorder * Genetic Disorder * Sensory Integration disorder * Auditory disorder Development delay children Inclusion Criteria: * Agreeing in consent * In the age range of 6-15 years old * Diagnosed of Developmental Delay

Design outcomes

Primary

Measure	Time frame	Description
Score of participation (< 3y)	baseline	Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores means a better outcome.)
Score of participation (3y > 15y)	Baseline	Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)

Secondary

Measure	Time frame	Description
Gene Test	Baseline	Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)

Countries

Taiwan

Outcome results