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

Child Development Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02930603
• Other study ID #: 102-5441B
• Status: Recruiting
• Start date: April 2014
• Est. completion date: April 2025

Study information

• Verified date: January 2020
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Ling Chen, MD, PhD
• Phone: +886-3-3281200
• Email: clingchen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Child Development Disorders
• Developmental Disabilities

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months	Comprehensive Developmental Inventory for Infants and Toddlers	baseline, 6 months, 12 months
Primary	Change from baseline of body function & structures in 6 months and 12 months	Bruininks- Oseretsky Test of Motor Proficiency II	baseline, 6 months, 12 months
Primary	Change from baseline of upper extremity function & structures in 6 months and 12 months	Quality of upper extremity skills test	baseline, 6 months, 12 months
Primary	Change from baseline of lower extremity function & structures in 6 months and 12 months	Pediatric Balance Scale	baseline, 6 months, 12 months
Primary	Change from baseline of Sensory and Perceptual function in 6 months and 12 months	Sensory Profile	baseline, 6 months, 12 months
Secondary	Change from baseline of activities in 6 months and 12 months	Functional Independence Measure for Children	baseline, 6 months, 12 months
Secondary	Change from baseline of Participation in 6 months and 12 months	Children Assessment of Participation and Enjoyment, Preferences for Activity of Children	baseline, 6 months, 12 months
Secondary	Change from baseline of Quality of Life in 6 months and 12 months	TNO-AZL Child Quality of Life Questionnaire	baseline, 6 months, 12 months
Secondary	Change from baseline of Personal & Environment factor in 6 months and 12 months	Parenting Stress Index,	baseline, 6 months, 12 months
Secondary	Change from baseline of Rehabilitation & community service factor in 6 months and 12 months	Measure of Processes of Care	baseline, 6 months, 12 months