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Clinical Trials/NCT04988139
NCT04988139
Unknown
Not Applicable

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

Taipei Medical University1 site in 1 country10 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Developmental Delay
Sponsor
Taipei Medical University
Enrollment
10
Locations
1
Primary Endpoint
changes of attention
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

changes of attention

Time Frame: 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

Time Frame: 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 Outcomes

  • changes of family impact(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
  • 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)
  • 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)
  • changes of walking speed(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
  • 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)
  • change of intelligence(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
  • Changes of functional performance(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
  • 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)
  • changes of balance(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)
  • changes of physical function(score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome)

Study Sites (1)

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