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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02686931
Other study ID # 102-0474A3
Secondary ID
Status Recruiting
Phase N/A
First received February 25, 2015
Last updated January 16, 2018
Start date January 2013
Est. completion date January 2019

Study information

Verified date November 2017
Source Chang Gung Memorial Hospital
Contact Chia-Ling Chen, PhD
Phone +886-3-3281200
Email clingchen@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study.


Description:

Three fundamental goals of early rehabilitation for children with DD are: optimizing body function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation in their lives. Knowledge of these developmental patterns of FPLA may be helpful in understanding, anticipating, and managing the problems of these patients. The investigators hypothesize that the course of developmental patterns in Function and Participation in Life Activities (FPLA) of patients with DD evolves with their age. The levels of functional recovery included developmental function, activity, participation, and quality of life (QOL). The aim of this study is to investigate the longitudinal outcomes in patients with DD evaluated by developmental function, activity, participation, and QOL. Additionally, the predictors in the initial stage in determining the final developmental patterns in FPLA of these children will be identified.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date January 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 20 Years
Eligibility Inclusion Criteria:

1. Children with aged 0-20 years

2. Control group: Children with orthopedic disease, Experimental group: Children with Developmental disabilities

Exclusion Criteria:

1. Low cooperative with follow-up

2. Low cooperative with clinical assessment

3. Low cooperative with questionnaire writing and data collection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT) Measurement of CDIIT baseline, six months and one year
Secondary Change of Chinese Child Developmental Inventory (CCDI) Measurement of CCDI baseline, six months and one year
Secondary Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II) Measurement of BOT-II baseline, six months and one year
Secondary Change of Quality of upper extremity skills test(QUEST) Measurement of QUEST baseline, six months and one year
Secondary Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II) Measurement of PDMS-II baseline, six months and one year
Secondary Change of Pediatric Balance Scale(PBS) Measurement of PBS baseline, six months and one year
Secondary Change of Gross Motor Function Measure, 66 items,(GMFM-66) Measurement of GMFM-66 baseline, six months and one year
Secondary Change of Modified Ashworth Scale (MAS) Measurement of MAS baseline, six months and one year
Secondary Change of Spinal Alignment and Range of Motion Measure (SAROMM) Measurement of SAROMM baseline, six months and one year
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