Effects of Educational Training on Children With Developmental Delay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Developmental Delay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes measurements will be performed by researchers who are blind to the groups' allocation.

Study Groups

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Intervention group

traditional rehabilitation programs with additional individualized educational training

Group Type ACTIVE_COMPARATOR

individualized educational training

Intervention Type OTHER

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

Control group

traditional rehabilitation programs without additional individualized educational training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No