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Clinical Trials/NCT02686931
NCT02686931
Unknown
N/A

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

Chang Gung Memorial Hospital1 site in 1 country2,000 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Developmental Disabilities
Sponsor
Chang Gung Memorial Hospital
Enrollment
2000
Locations
1
Primary Endpoint
Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
January 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: baseline, six months and one year

Measurement of CDIIT

Secondary Outcomes

  • Change of Pediatric Balance Scale(PBS)(baseline, six months and one year)
  • Change of Gross Motor Function Measure, 66 items,(GMFM-66)(baseline, six months and one year)
  • Change of Modified Ashworth Scale (MAS)(baseline, six months and one year)
  • Change of Spinal Alignment and Range of Motion Measure (SAROMM)(baseline, six months and one year)
  • 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)

Study Sites (1)

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