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

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ClinicalTrials.gov Identifier: NCT02686931
Recruitment Status : Unknown
Verified November 2017 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 22, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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

Condition or disease
Developmental Disabilities

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.

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Study Type : Observational
Estimated 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 : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT) [ Time Frame: baseline, six months and one year ]
    Measurement of CDIIT


Secondary Outcome Measures :
  1. Change of Chinese Child Developmental Inventory (CCDI) [ Time Frame: baseline, six months and one year ]
    Measurement of CCDI

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

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

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

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

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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Control and experimental groups
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686931


Contacts
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Contact: Chia-Ling Chen, PhD +886-3-3281200 ext 8147 clingchen@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, PhD    +886-3-3281200 ext 8147    clingchen@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chia-Ling Chen, PhD Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02686931    
Other Study ID Numbers: 102-0474A3
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Gung Memorial Hospital:
Developmental delayed
Orthopedic disease
Longitudinal study
Additional relevant MeSH terms:
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Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders