Effects of Virtual Reality System in Children With Developmental Delays

Developmental Delays Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184715
• Other study ID #: HP-01
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2014
• Last updated: July 8, 2014
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2014
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• confirmed to have developmental delays

• provided informed consent

• 2 to 12 years old

Exclusion Criteria:

• failed to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Developmental Delays

Intervention

Other:
• virtual reality system
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ru-Lan Hsieh

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No