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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome:

  • 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
  • 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
  • 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
  • Change from baseline of lower extremity function & structures in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Pediatric Balance Scale
  • Change from baseline of Sensory and Perceptual function in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Sensory Profile


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline of activities in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Functional Independence Measure for Children
  • 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
  • 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
  • Change from baseline of Personal & Environment factor in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Parenting Stress Index,
  • 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


Original Secondary Outcome: Same as current

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: October 3, 2016
Date Started: April 2014
Date Completion: March 2017
Last Updated: October 10, 2016
Last Verified: September 2016