Effects of Educational Training on Children With Developmental Delay

Developmental Delay Clinical Trial

Official title:

Therapeutic Effects of Individualized Educational Training on Preschool Children With Global Developmental Delay

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04988139
• Other study ID #: 2021SKHADR032
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886228332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Other:
• individualized 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

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of daily activity	score assessed by Pediatric Daily Occupation Scale	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Primary	changes of attention	score assessed by Conners Kiddie Continous Performance Test, 2nd edition	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	change of visual motor integration	score assessed by Beery-Buktenica Visual Motor Integration	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	change of intelligence	score assessed by Wechsler Intelligence Scale of children	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	Changes of functional performance	score assessed by Pediatric Outcome Data Collection Instrument	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	changes of quality of life	score assessed by Pediatric Quality of Life Inventory	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	changes of family impact	score assessed by Child Health Questionnaire, parent form 28	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	changes of walking speed	walking speed	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	changes of chair climbing speed	stairs climbing speed	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	changes of balance	one leg standing time	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	changes of balance and coordination	timed up and go test	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary	changes of physical function	5 times sit to stand test	score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome