The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case

January 16, 2018 updated by: Chang Gung Memorial Hospital

The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case: A Longitudinal Study

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

Study Overview

Status

Unknown

Conditions

Detailed Description

Three fundamental goals of early rehabilitation for children with DD are: optimizing body function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation in their lives. Knowledge of these developmental patterns of FPLA may be helpful in understanding, anticipating, and managing the problems of these patients. The investigators hypothesize that the course of developmental patterns in Function and Participation in Life Activities (FPLA) of patients with DD evolves with their age. The levels of functional recovery included developmental function, activity, participation, and quality of life (QOL). The aim of this study is to investigate the longitudinal outcomes in patients with DD evaluated by developmental function, activity, participation, and QOL. Additionally, the predictors in the initial stage in determining the final developmental patterns in FPLA of these children will be identified.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Control and experimental groups

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Low cooperative with follow-up
  2. Low cooperative with clinical assessment
  3. Low cooperative with questionnaire writing and data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Control: Normal developmental children with orthopedic disease
Experimental
Experimental: Developmental delayed children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
Time Frame: baseline, six months and one year
Measurement of CDIIT
baseline, six months and one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Chinese Child Developmental Inventory (CCDI)
Time Frame: baseline, six months and one year
Measurement of CCDI
baseline, six months and one year
Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II)
Time Frame: baseline, six months and one year
Measurement of BOT-II
baseline, six months and one year
Change of Quality of upper extremity skills test(QUEST)
Time Frame: baseline, six months and one year
Measurement of QUEST
baseline, six months and one year
Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II)
Time Frame: baseline, six months and one year
Measurement of PDMS-II
baseline, six months and one year
Change of Pediatric Balance Scale(PBS)
Time Frame: baseline, six months and one year
Measurement of PBS
baseline, six months and one year
Change of Gross Motor Function Measure, 66 items,(GMFM-66)
Time Frame: baseline, six months and one year
Measurement of GMFM-66
baseline, six months and one year
Change of Modified Ashworth Scale (MAS)
Time Frame: baseline, six months and one year
Measurement of MAS
baseline, six months and one year
Change of Spinal Alignment and Range of Motion Measure (SAROMM)
Time Frame: baseline, six months and one year
Measurement of SAROMM
baseline, six months and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chia-Ling Chen, PhD, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102-0474A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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