Developmental Delay
Conditions
Keywords
preschool children, developmental delay, educational training, therapeutic effects
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.
Interventions
OTHERindividualized educational training
50 min per session, one session per week, 4 sessions per month, of individualized educational training to preschool children with developmental delays under traditional rehabilitation programs
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes measurements will be performed by researchers who are blind to the groups' allocation.
Intervention model description
A total of 20 children with developmental delays 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 additional educational training) and the control group (traditional rehabilitation program without educational training). The intervention group will receive 1 month of individualized educational training, 50 min per session, 1 session per week, a total of 4 sessions. All of the evaluations will be performed before training, re-evaluated 1 month after completion of treatment, and 3 months after completion of the treatment in the study group. The control group will be evaluated at the baseline, 1 month, and 6 months later, respectively.
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* preschool children with a diagnosis of developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Exclusion criteria
* age less than 3 or greater than 6 of children diagnosed with developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 walking speed | score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome | walking 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 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 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 |
| 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 |
| 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 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 |
Countries
Taiwan
Contacts
Primary ContactRu-Lan Hsieh, MD
Backup ContactRu-Lan Hsieh, MD
Outcome results
None listed