Effects of Virtual Reality System in Children With Developmental Delays

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays.

Detailed Description
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Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in addition to regular rehabilitation programs.

Official Title
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The Additional Therapeutic Effects of Virtual Reality System in Children With Developmental Delays

Conditions
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Developmental Delays

Intervention / Treatment
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* Other: virtual reality system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed to have developmental delays provided informed consent 2 to 12 years old Exclusion Criteria: failed to provide informed consent

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual reality video game<br>Participants received rehabilitation treatment and additional virtual reality system (30 minutes of interactive virtual reality system play, two times per week, in eight sessions over a 4-week span) for 1 month, followed by rehabilitation treatment for 1 month | Other: virtual reality system<br>* The participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month.<br>|
| Placebo Comparator: Virtual reality system<br>received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system (30 minutes of interactive video game play, two times per week, in eight sessions over a 4-week span) during the one month of intervention period. | Other: virtual reality system<br>* The participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health of children (Pediatric Quality of Life Inventory) | Following the recruitment and baseline assessment, outcome measures were assessed before treatment (Time 0), at the end of first intervention in the fourth week (Time 1), and at the end of second intervention in the eighth week (Time 2). | changes from baseline at one and two months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality system, children, developmental delay