Effects of Educational Training on Children With Developmental Delay
- Conditions
- Developmental Delay
- Interventions
- Other: individualized educational training
- Registration Number
- NCT04988139
- Lead Sponsor
- Taipei Medical University
- Brief Summary
Using a single-blind, randomized controlled design to investigate the additional therapeutic effects of individualized educational training on traditional rehabilitation programs for preschool children with developmental delays.
- Detailed Description
A total of 20 preschool children with developmental delay who are receiving traditional rehabilitation programs will be enrolled.
The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with individualized educational training: one time per week, 50 min per session, with a total of 4 sessions in one month) and the control group (traditional rehabilitation program without individualized educational training).
Therapeutic effects, including pediatric daily activity, attention, cognitive function, functional performance, quality of life, and physical functional performance at baseline, after one month of treatment, and 3 months after the treatment, will be evaluated.
The evaluators will be blinded to the group's allocation during the whole course of the intervention.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- preschool children with a diagnosis of developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
- age less than 3 or greater than 6 of children diagnosed with developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group individualized educational training traditional rehabilitation programs with additional individualized educational training
- Primary Outcome Measures
Name Time Method changes of attention score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome score assessed by Conners Kiddie Continous Performance Test, 2nd edition
changes of daily activity score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome score assessed by Pediatric Daily Occupation Scale
- Secondary Outcome Measures
Name Time Method changes of family impact score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome score assessed by Child Health Questionnaire, parent form 28
changes of chair climbing speed score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome stairs climbing speed
change of visual motor integration score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome score assessed by Beery-Buktenica Visual Motor Integration
changes of walking speed score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome walking speed
changes of balance and coordination score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome timed up and go test
change of intelligence score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome score assessed by Wechsler Intelligence Scale of children
Changes of functional performance score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome score assessed by Pediatric Outcome Data Collection Instrument
changes of quality of life score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome score assessed by Pediatric Quality of Life Inventory
changes of balance score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome one leg standing time
changes of physical function score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome 5 times sit to stand test
Trial Locations
- Locations (1)
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan