NCT02686931

Brief Summary

Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 18, 2018

Status Verified

November 1, 2017

Enrollment Period

5.9 years

First QC Date

February 25, 2015

Last Update Submit

January 16, 2018

Conditions

Developmental Disabilities

Keywords

Developmental delayedOrthopedic diseaseLongitudinal study

Outcome Measures

Primary Outcomes (1)

  • Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)

    Measurement of CDIIT

    baseline, six months and one year

Secondary Outcomes (8)

  • Change of Chinese Child Developmental Inventory (CCDI)

    baseline, six months and one year

  • Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II)

    baseline, six months and one year

  • Change of Quality of upper extremity skills test(QUEST)

    baseline, six months and one year

  • Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II)

    baseline, six months and one year

  • Change of Pediatric Balance Scale(PBS)

    baseline, six months and one year

  • +3 more secondary outcomes

Study Arms (2)

Control

Control: Normal developmental children with orthopedic disease

Experimental

Experimental: Developmental delayed children

Eligibility Criteria

AgeUp to 20 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:

  • Children with aged 0-20 years
  • Control group: Children with orthopedic disease, Experimental group: Children with Developmental disabilities

You may not qualify if:

  • Low cooperative with follow-up
  • Low cooperative with clinical assessment
  • Low cooperative with questionnaire writing and data collection

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, PhD

    Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Ling Chen, 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

February 25, 2015

First Posted

February 22, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

January 18, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)