NCT02930603

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

June 24, 2020

Status Verified

January 1, 2020

Enrollment Period

11 years

First QC Date

October 3, 2016

Last Update Submit

June 22, 2020

Conditions

Child Development Disorders

Keywords

Developmental DisabilitiesBody function and body structureParticipationLife activitiesQuality of Life

Outcome Measures

Primary Outcomes (5)

  • 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

    baseline, 6 months, 12 months

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

    Bruininks- Oseretsky Test of Motor Proficiency II

    baseline, 6 months, 12 months

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

    Quality of upper extremity skills test

    baseline, 6 months, 12 months

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

    Pediatric Balance Scale

    baseline, 6 months, 12 months

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

    Sensory Profile

    baseline, 6 months, 12 months

Secondary Outcomes (5)

  • Change from baseline of activities in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of Participation in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of Quality of Life in 6 months and 12 months

    baseline, 6 months, 12 months

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

    baseline, 6 months, 12 months

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

    baseline, 6 months, 12 months

Study Arms (2)

Control

Control: Healthy child

Experimental

Patients with Developmental Disabilities

Eligibility Criteria

Age7 Days - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Control and experimental groups

You may qualify if:

  • Patients with Developmental Disabilities
  • Age 0-25 y/o
  • Agree to sign informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Chia-Ling Chen, MD, PhD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen, MD, PhD

CONTACT

+886-3-3281200clingchen@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 12, 2016

Study Start

April 1, 2014

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

June 24, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)