Clinical trial NCT02686931: The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case
Official title: The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Developmental Disabilities
Keywords: Developmental delayed
Orthopedic disease
Longitudinal study
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 2000
Sex: ALL
Maximum age (years): 20
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: Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
timeFrame: baseline, six months and one year
Secondary outcomes:
measure: Change of Chinese Child Developmental Inventory (CCDI)
timeFrame: baseline, six months and one year
measure: Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II)
timeFrame: baseline, six months and one year
measure: Change of Quality of upper extremity skills test(QUEST)
timeFrame: baseline, six months and one year
measure: Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II)
timeFrame: baseline, six months and one year
measure: Change of Pediatric Balance Scale(PBS)
timeFrame: baseline, six months and one year
measure: Change of Gross Motor Function Measure, 66 items,(GMFM-66)
timeFrame: baseline, six months and one year
measure: Change of Modified Ashworth Scale (MAS)
timeFrame: baseline, six months and one year
measure: Change of Spinal Alignment and Range of Motion Measure (SAROMM)
timeFrame: baseline, six months and one year
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
name: Chia-Ling Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: