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A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities

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ClinicalTrials.gov Identifier: NCT02930603
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities

Condition or disease
Child Development Disorders

Detailed Description:
Developmental Disabilities (DD) is defined as a group of neurodevelopmental issues, leading to significant lag in one or more areas (e.g. cognition, speech, motor, self-care and psychosocial function) for various reasons. On the basis of International Classification of Functioning, Disability and Health -Children and Youth Version (ICF-CY) framework, problems related to Developmental Disabilities further limit activities of daily living (ADL) and participation of patients.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
Study Start Date : April 2014
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Control
Control: Healthy child
Experimental
Patients with Developmental Disabilities



Primary Outcome Measures :
  1. Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Comprehensive Developmental Inventory for Infants and Toddlers

  2. Change from baseline of body function & structures in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Bruininks- Oseretsky Test of Motor Proficiency II

  3. Change from baseline of upper extremity function & structures in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Quality of upper extremity skills test

  4. Change from baseline of lower extremity function & structures in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Pediatric Balance Scale

  5. Change from baseline of Sensory and Perceptual function in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Sensory Profile


Secondary Outcome Measures :
  1. Change from baseline of activities in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Functional Independence Measure for Children

  2. Change from baseline of Participation in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Children Assessment of Participation and Enjoyment, Preferences for Activity of Children

  3. Change from baseline of Quality of Life in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    TNO-AZL Child Quality of Life Questionnaire

  4. Change from baseline of Personal & Environment factor in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Parenting Stress Index,

  5. Change from baseline of Rehabilitation & community service factor in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Measure of Processes of Care



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 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. Patients with Developmental Disabilities
  2. Age 0-25 y/o
  3. Agree to sign informed consent

Exclusion Criteria:

  1. Active medical condition (e.g. infection)
  2. Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
  3. Concurrent illness or disease not typically associated with DD (e.g. pneumonia)

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): NCT02930603


Contacts
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Contact: Chia-Ling Chen, MD, PhD +886-3-3281200 ext 8148 clingchen@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, MD, PhD    +886-3-3281200 ext 8147    clingchen@gmail.com   
Principal Investigator: Chia-Ling Chen, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Director: Chia-Ling Chen, MD, PhD Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02930603    
Other Study ID Numbers: 102-5441B
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Gung Memorial Hospital:
Developmental Disabilities
Body function and body structure
Participation
Life activities
Quality of Life
Additional relevant MeSH terms:
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Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders