Effects of Virtual Reality System in Children With Developmental Delays

Phase 4

Completed

• Conditions: Developmental Delays
• Interventions: Other: virtual reality system

• Registration Number: NCT02184715
• Lead Sponsor: Ru-Lan Hsieh

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-01
• Study Completion: 2011-12
• Status Verified: 2014-07
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-08
• Last Update Submitted: 2014-07-08
• Study First Posted: 2014-07-09
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• confirmed to have developmental delays
• provided informed consent
• 2 to 12 years old

Exclusion Criteria

• failed to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Virtual reality system	virtual reality system	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.
Virtual reality video game	virtual reality system	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

Primary Outcome Measures

Name	Time	Method
health of children (Pediatric Quality of Life Inventory)	changes from baseline at one and two months.	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).

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan