Clinical trial NCT04988139: Effects of Educational Training on Children With Developmental Delay
Official title: Therapeutic Effects of Individualized Educational Training on Preschool Children With Global Developmental Delay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Delay
Keywords: preschool children
developmental delay
educational training
therapeutic effects
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes of daily activity
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of attention
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary outcomes:
measure: change of visual motor integration
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: change of intelligence
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: Changes of functional performance
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of quality of life
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of family impact
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of walking speed
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of chair climbing speed
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of balance
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of balance and coordination
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of physical function
timeFrame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: