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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02686931
Collaborator
(none)
2,000
Enrollment
1
Location
72
Duration (Months)
27.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case: A Longitudinal Study
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Jan 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Control: Normal developmental children with orthopedic disease
    Experimental

    Experimental: Developmental delayed children

    Outcome Measures

    Primary Outcome Measures

    1. Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT) [baseline, six months and one year]

      Measurement of CDIIT

    Secondary Outcome Measures

    1. Change of Chinese Child Developmental Inventory (CCDI) [baseline, six months and one year]

      Measurement of CCDI

    2. Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II) [baseline, six months and one year]

      Measurement of BOT-II

    3. Change of Quality of upper extremity skills test(QUEST) [baseline, six months and one year]

      Measurement of QUEST

    4. Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II) [baseline, six months and one year]

      Measurement of PDMS-II

    5. Change of Pediatric Balance Scale(PBS) [baseline, six months and one year]

      Measurement of PBS

    6. Change of Gross Motor Function Measure, 66 items,(GMFM-66) [baseline, six months and one year]

      Measurement of GMFM-66

    7. Change of Modified Ashworth Scale (MAS) [baseline, six months and one year]

      Measurement of MAS

    8. Change of Spinal Alignment and Range of Motion Measure (SAROMM) [baseline, six months and one year]

      Measurement of SAROMM

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang Gung Memorial Hospital Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02686931
    Other Study ID Numbers:
    • 102-0474A3
    First Posted:
    Feb 22, 2016
    Last Update Posted:
    Jan 18, 2018
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Chang Gung Memorial Hospital
    Developmental delayed
    Orthopedic disease
    Longitudinal study
    Additional relevant MeSH terms:
    Developmental Disabilities

    Study Results

    No Results Posted as of Jan 18, 2018