Tele-Rehabilitation Solutions With Innovative Cores of Extended Reality Based on Metaverse
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility: Acceptability of Intervention as assessed by TAM3 (Technology Acceptance Model 3) questionnaire.
研究概览
简要总结
The main objective of the TERSICORE project is the development of a new advanced set of exergames in the Metaverse that can be used in all clinical and home rehabilitation devices to improve the cognitive therapy of neurological patients by exploiting the potential of social rehabilitation. Five specific exargames will be developed: a) Cooking therapy (Coordinating in a kitchen to complete a dish through shared activities); b) Escape Room (Exiting a simulated room by solving problems and logic puzzles); c) Nostalgia Bits (Sharing personal reminiscence narratives within simulated spaces); d) NeuroTeam (Mindfulness); and e) Truman Show Exploration of an urban space and role-playing.
All exargames will be validated on a small population of neurological patients according to cognitive profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients:
- •Adult age: 18-85 years
- •Education: at least 5 years
- •Cognitive deficits at routine outpatient clinical neuropsychological assessment (at least one test with p.e. 0/1) in subjects with focal neurological insult - (post-Stroke, post-Cranial Trauma)
- •neurodegenerative disorders - (Multiple Sclerosis, Parkinson's, Mild Cognitive Impairment, AD-like)
排除标准
- •for patients:
- •Severe cognitive impairment MMSE <22
- •Presence of severe deficits in visual acuity, hearing perception, communication and severe dysmetria, such as to interfere with the administration of the activities proposed by TERSICORE
- •Presence of major psychiatric or neurological pathologies other than the inclusion criteria
研究组 & 干预措施
Arm End-Users
Acceptability evaluation of TERSICORE digital platform
干预措施: Cognitive rehabilitation with TERSICORE digital platform (Device)
结局指标
主要结局
Feasibility: Acceptability of Intervention as assessed by TAM3 (Technology Acceptance Model 3) questionnaire.
时间窗: Measured at discharge or 7 days post baseline
Number of participants with high level of behavioral intention (TAM3 score range 1-7), with higher scores indicating greater acceptability of intervention.
Feasibility: Perceived usability of a technological system or application as assessed by SUS (System Usability Scale)
时间窗: Measured at discharge or 7 days post baseline
Number of participants with high level of high level of behavioral intention (SUS score range 1-5), high score indicating greater perceived usability of a technological system or application
Feasibility: User experience of intervention as assessed by UEQ (User Experience Questionnaire)
时间窗: Measured at discharge or 7 days post baseline
Number of participants with high level of comprehensive impression of user experience (UEQ score range 1-7), with higher scores indicating greater impression of user experience.
Feasibility: Intrinsic motivation as assessed by IMI subscale (Intrinsic Motivation Inventory).
时间窗: Measured at discharge or 7 days post baseline
Number of participants with high level of behavioral intention (IMI score range 1-7), with higher scores indicating greater intrinsic motivation.
Feasibility: Sickness elicited by modern virtual reality systems as assessed by SSQ (Simulator Sickness Questionnaire).
时间窗: Measured at discharge or 7 days post baseline
Number of subjects with high level of sickness (SSQ score range 0-3), with higher scores indicating greater simulator sickness.
次要结局
- Language(Measured at baseline and at the end of the rehabilitation sessions (6 weeks))
- Working memory and attention(Measured at before and at the end of the rehabilitation sessions (6 weeks))
- Visual-spatial ability(Measured at before and at the end of the rehabilitation sessions (6 weeks))
- Social metrics(Measure recorded during all rehabilitative sessions (6 weeks))
- Emotional state(Measured at baseline and at the end of the rehabilitation sessions (6 weeks))
- Social cognition(Measured at baseline and at the end the rehabilitation sessions (6 weeks))
- Gross manual dexterity level(Measured at baseline and at the end the rehabilitation sessions (6 weeks))
- Global cognitive functioning(Measured at baseline and at the end the rehabilitation sessions (6 weeks))
- Episodic memory(Measured at baseline and at the end the rehabilitation sessions (6 weeks))
研究者
Antonio Cerasa
Director
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy