Child Development DisordersNCT02930603
A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
An observational study of Child Development Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities Read more about this study
- Who is it for?
- Ages 7 days to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development Disorders
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Control and experimental groups
Who may be able to join
- Patients with Developmental Disabilities
- Age 0-25 y/o
- Agree to sign informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Chia-Ling Chen, MD, PhD, +886-3-3281200 ext. 8147, clingchen@gmail.com
Chia-Ling Chen, MD, PhD
About this study
A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities
Read the 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.
- Conditions
- Child Development Disorders
- Keywords
- Developmental Disabilities, Body function and body structure, Participation, Life activities, Quality of Life
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Control: Healthy child | |
| Experimental | Patients with Developmental Disabilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: baseline, 6 months, 12 months
Change from baseline of lower extremity function & structures in 6 months and 12 months
Pediatric Balance Scale
Measured: baseline, 6 months, 12 months
Change from baseline of Sensory and Perceptual function in 6 months and 12 months
Sensory Profile
Measured: baseline, 6 months, 12 months
Secondary outcomes (5)
Change from baseline of activities in 6 months and 12 months
Functional Independence Measure for Children
Measured: 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
Measured: 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
Measured: baseline, 6 months, 12 months
Change from baseline of Personal & Environment factor in 6 months and 12 months
Parenting Stress Index,
Measured: baseline, 6 months, 12 months
Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
Measure of Processes of Care
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startApr 2014
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development DisordersStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930603
- Sponsor's protocol ID
- 102-5441B
- Status last verified
- Jan 2020
- First submitted
- 3 Oct 2016
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT02930603
- Acronym / sponsor ID
- 102-5441B
- Conditions
- Child Development Disorders
- Keywords
- Developmental Disabilities, Body function and body structure, Participation, Life activities, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Control: Healthy child |
| Experimental | – | –Patients with Developmental Disabilities |
Who may qualify
- Ages
- 7 days to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Control and experimental groups
Key inclusion criteria (3 listed)
- Patients with Developmental Disabilities
- Age 0-25 y/o
- Agree to sign informed consent
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
5 secondary outcomes
Change from baseline of activities in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Participation in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Quality of Life in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Personal & Environment factor in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD, PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ling Chen, MD, PhD (+886-3-3281200 ext. 8148, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.