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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02930603
Date of registration:	03/10/2016
Prospective Registration:	No
Primary sponsor:	Chang Gung Memorial Hospital
Public title:	A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
Scientific title:	A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
Date of first enrolment:	April 2014
Target sample size:	800
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02930603
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Taiwan

Contacts

Name:	Chia-Ling Chen, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Chang Gung Memorial Hospital

Name:	Chia-Ling Chen, MD, PhD
Address:
Telephone:	+886-3-3281200
Email:	clingchen@gmail.com
Affiliation:

Name:	Chia-Ling Chen, MD, PhD
Address:
Telephone:	+886-3-3281200
Email:	clingchen@gmail.com
Affiliation:

Key inclusion & exclusion 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)

Age minimum: N/A
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

Child Development Disorders

Intervention(s)

Primary Outcome(s)

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]

Change from baseline of upper extremity function & structures in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of Sensory and Perceptual function in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of body function & structures in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of lower extremity function & structures in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Secondary Outcome(s)

Change from baseline of Participation in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of activities 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 Quality of Life 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]

Secondary ID(s)

102-5441B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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