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