A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Child Development Disorders
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Change from baseline of body function & structures in 6 months and 12 months
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with Developmental Disabilities
- •Age 0-25 y/o
- •Agree to sign informed consent
Exclusion Criteria
- •Active medical condition (e.g. infection)
- •Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
- •Concurrent illness or disease not typically associated with DD (e.g. pneumonia)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Change from baseline of Participation in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Personal & Environment factor in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of activities in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Quality of Life in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Rehabilitation & community service factor in 6 months and 12 months(baseline, 6 months, 12 months)