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

Recruiting

• Conditions: Child Development Disorders

• Registration Number: NCT02930603
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-24
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline of body function & structures in 6 months and 12 months	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	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	baseline, 6 months, 12 months	Pediatric Balance Scale
Change from baseline of Sensory and Perceptual function in 6 months and 12 months	baseline, 6 months, 12 months	Sensory Profile
Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months	baseline, 6 months, 12 months	Comprehensive Developmental Inventory for Infants and Toddlers

Secondary Outcome Measures

Name	Time	Method
Change from baseline of Participation in 6 months and 12 months	baseline, 6 months, 12 months	Children Assessment of Participation and Enjoyment, Preferences for Activity of Children
Change from baseline of Personal & Environment factor in 6 months and 12 months	baseline, 6 months, 12 months	Parenting Stress Index,
Change from baseline of Quality of Life in 6 months and 12 months	baseline, 6 months, 12 months	TNO-AZL Child Quality of Life Questionnaire
Change from baseline of activities in 6 months and 12 months	baseline, 6 months, 12 months	Functional Independence Measure for Children
Change from baseline of Rehabilitation & community service factor in 6 months and 12 months	baseline, 6 months, 12 months	Measure of Processes of Care

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan