The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case

Developmental Disabilities Clinical Trial

Official title:

The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case: A Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02686931
• Other study ID #: 102-0474A3
• 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
• 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

Related Conditions & MeSH terms

• Developmental Disabilities

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