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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02930603

Enrollment

800

Registered

2016-10-12

Start date

2014-04-30

Completion date

2025-04-30

Last updated

2020-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development Disorders

Keywords

Developmental Disabilities, Body function and body structure, Participation, Life activities, Quality of Life

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Days to 25 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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 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 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 Personal & Environment factor in 6 months and 12 months	baseline, 6 months, 12 months	Parenting Stress Index,
Change from baseline of Rehabilitation & community service factor in 6 months and 12 months	baseline, 6 months, 12 months	Measure of Processes of Care

Countries

Taiwan

Contacts

Primary ContactChia-Ling Chen, MD, PhD

clingchen@gmail.com+886-3-3281200

Outcome results