Feasibility and Usability of a Virtual Reality System to Improve Standardized Rehabilitation in Patients With Moderate Intellectual Disability and Severe Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time
研究概览
简要总结
Intellectual disability (ID) and autism spectrum disorder (ASD) are often co-occurring neurodevelopmental disorders that require composite intervention. However, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. The Virtual Reality Rehabilitation System (VRRS) is a medical device is recognized as one of the most advanced systems to rehabilitate patients with motor, cognitive, linguistic and behavioral disorders. The use of VRRS offers the opportunity to adapting task parameters according to the patient's performance and the virtual system increases engagement and avoids boredom and frustration. the patients underwent a two months experimental intervention integrated into the regular activity of a semi-residential center for autistic adolescents and young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental Group (EG)
The group consists of patients diagnosed with autism spectrum disorder and intellectual disability who underwent treatment with VRRS
干预措施: Rehabilitation with VRRS (Device)
结局指标
主要结局
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time
时间窗: T0 (BASELINE) -T1 (SIX MONTHS)
During the execution of the exercise, the attention time maintained on the screen was recorded.
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: the number of repetitions of the exercises.
时间窗: T0 (BASELINE) -T1 (SIX MONTHS)
During the execution of the exercise, the number of repetitions of the exercises was recorded
Usability questionnaire
时间窗: T0 (BASELINE) - T1 (SIX MONTHS)
The questionnaire used a 5-point ordinal scale, where 5 is the most favorable score and 1 is the least favorable score; the score 3 corresponds to "no opinion". The questionnaire will be completed by all therapists at the end of the treatment.
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters:global scores for exercise.
时间窗: T0 (BASELINE) -T1 (SIX MONTHS)
The total scores obtained were recorded during the execution of the exercise.
次要结局
未报告次要终点
研究者
Francesca Cucinotta
Principal Investigator
IRCCS Centro Neurolesi "Bonino-Pulejo"