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RecruitingNCT02930603Updated Jun 24, 2020

A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities

An observational study in Child Development Disorders, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 7 Days to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-24.

Sponsored by Chang Gung Memorial Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
7 Days to 25 Years
Sex
All
01

Study summary

A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities

Read the detailed description

Developmental Disabilities (DD) is defined as a group of neurodevelopmental issues, leading to significant lag in one or more areas (e.g. cognition, speech, motor, self-care and psychosocial function) for various reasons. On the basis of International Classification of Functioning, Disability and Health -Children and Youth Version (ICF-CY) framework, problems related to Developmental Disabilities further limit activities of daily living (ADL) and participation of patients.

02

Conditions studied

  • Child Development Disorders

Keywords

  • Developmental Disabilities
  • Body function and body structure
  • Participation
  • Life activities
  • Quality of Life
03

In context

Developmental Disabilities

285 studies on the registry are indexed under Developmental Disabilities; 64 are open to participants now.

This study's planned enrollment of 800 is above the median of 150 across 80 observational studies indexed under Developmental Disabilities.

Browse Developmental Disabilities studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Days to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Control and experimental groups

Inclusion criteria

  1. Patients with Developmental Disabilities
  2. Age 0-25 y/o
  3. Agree to sign informed consent

Exclusion criteria

Exclusion Criteria:

  1. Active medical condition (e.g. infection)
  2. Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
  3. Concurrent illness or disease not typically associated with DD (e.g. pneumonia)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control

    Control: Healthy child

  • Experimental

    Patients with Developmental Disabilities

06

What researchers measure

Primary outcomes

  1. Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months

    Comprehensive Developmental Inventory for Infants and Toddlers

    Time frame: baseline, 6 months, 12 months

  2. Change from baseline of body function & structures in 6 months and 12 months

    Bruininks- Oseretsky Test of Motor Proficiency II

    Time frame: baseline, 6 months, 12 months

  3. Change from baseline of upper extremity function & structures in 6 months and 12 months

    Quality of upper extremity skills test

    Time frame: baseline, 6 months, 12 months

  4. Change from baseline of lower extremity function & structures in 6 months and 12 months

    Pediatric Balance Scale

    Time frame: baseline, 6 months, 12 months

  5. Change from baseline of Sensory and Perceptual function in 6 months and 12 months

    Sensory Profile

    Time frame: baseline, 6 months, 12 months

Secondary outcomes

  1. Change from baseline of activities in 6 months and 12 months

    Functional Independence Measure for Children

    Time frame: baseline, 6 months, 12 months

  2. Change from baseline of Participation in 6 months and 12 months

    Children Assessment of Participation and Enjoyment, Preferences for Activity of Children

    Time frame: baseline, 6 months, 12 months

  3. Change from baseline of Quality of Life in 6 months and 12 months

    TNO-AZL Child Quality of Life Questionnaire

    Time frame: baseline, 6 months, 12 months

  4. Change from baseline of Personal & Environment factor in 6 months and 12 months

    Parenting Stress Index,

    Time frame: baseline, 6 months, 12 months

  5. Change from baseline of Rehabilitation & community service factor in 6 months and 12 months

    Measure of Processes of Care

    Time frame: baseline, 6 months, 12 months

07

Study locations

1 of 1 sites recruiting
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
    • Chia-Ling Chen, MD, PhD · Contact · clingchen@gmail.com · +886-3-3281200
    • Chia-Ling Chen, MD, PhD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02930603
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Oct 12, 2016
Start date
Apr 2014
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Jun 24, 2020

Study contacts

Chia-Ling Chen, MD, PhD
Contact
clingchen@gmail.com
+886-3-3281200 ext. 8148
Chia-Ling Chen, MD, PhD
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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