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

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

Study Overview

• Status: Recruiting
• Conditions: Child Development Disorders

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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Control and experimental groups

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Control: Healthy child
Experimental; Patients with Developmental Disabilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change from baseline of lower extremity function & structures in 6 months and 12 months	Pediatric Balance Scale	baseline, 6 months, 12 months
Change from baseline of Sensory and Perceptual function in 6 months and 12 months	Sensory Profile	baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of activities in 6 months and 12 months	Functional Independence Measure for Children	baseline, 6 months, 12 months
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
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
Change from baseline of Personal & Environment factor in 6 months and 12 months	Parenting Stress Index,	baseline, 6 months, 12 months
Change from baseline of Rehabilitation & community service factor in 6 months and 12 months	Measure of Processes of Care	baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ANTICIPATED): April 1, 2025
• Study Completion (ANTICIPATED): April 1, 2025

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (ESTIMATE): October 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Developmental Disabilities; Participation; Life activities; Body function and body structure
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: 102-5441B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO