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临床试验/NCT02184715
NCT02184715已完成4 期

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

Ru-Lan Hsieh2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2009年1月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
157
试验地点
2
主要终点
health of children (Pediatric Quality of Life Inventory)

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • failed to provide informed consent

研究组 & 干预措施

Virtual reality video game

Active Comparator

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

干预措施: virtual reality system (Other)

Virtual reality system

Placebo Comparator

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.

干预措施: virtual reality system (Other)

结局指标

主要结局

health of children (Pediatric Quality of Life Inventory)

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Ru-Lan Hsieh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ru-Lan Hsieh

MD

Taipei Medical University

研究点 (2)

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