The Additional Therapeutic Effects of Virtual Reality System in Children With Developmental Delays
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- health of children (Pediatric Quality of Life Inventory)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •confirmed to have developmental delays
- •provided informed consent
- •2 to 12 years old
Exclusion Criteria
- •failed to provide informed consent
Arms & Interventions
Virtual reality video game
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
Intervention: virtual reality system (Other)
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.
Intervention: virtual reality system (Other)
Outcomes
Primary Outcomes
health of children (Pediatric Quality of Life Inventory)
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Ru-Lan Hsieh
MD
Taipei Medical University