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

• Conditions: Developmental Disabilities

• Registration Number: NCT02686931
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Status Verified: 2017-11
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)	baseline, six months and one year	Measurement of CDIIT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan