Clinical trial NCT02930603: A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
Official title: A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development Disorders
Keywords: Developmental Disabilities
Body function and body structure
Participation
Life activities
Quality of Life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 800
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control and experimental groups

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of body function & structures in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of upper extremity function & structures in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of lower extremity function & structures in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Sensory and Perceptual function in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline of activities in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Participation in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Quality of Life in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Personal & Environment factor in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References: