Multiple Sclerosis, Neurological Disorder, Parkinson Disease, Stroke, Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
DEVICECognitive rehabilitation with TERSICORE digital platform
Small groups of end-users will participate in various cognitive tasks carried out in common virtual environments (Metaverse).
Sponsors
Istituto per la Ricerca e l'Innovazione Biomedica
H.S.P.I. s.p.a.
Catholic University of the Sacred Heart
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Acceptability of Intervention as assessed by TAM3 (Technology Acceptance Model 3) questionnaire. | 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) | 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) | 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). | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Language | Measured at baseline and at the end of the rehabilitation sessions (6 weeks) | Changes in phonemic/semantic language ability as assessed by Verbal Fluency |
| Working memory and attention | Measured at before and at the end of the rehabilitation sessions (6 weeks) | Changes in executive functioning as assessed by Trial Making Test |
| Visual-spatial ability | Measured at before and at the end of the rehabilitation sessions (6 weeks) | Changes in visual-spatial ability as assessed by Rey Figure |
| Social metrics | Measure recorded during all rehabilitative sessions (6 weeks) | Proximity, frequency of interactions, synchrony and coordination. All these parameters will be measured by sensors |
| Emotional state | Measured at baseline and at the end of the rehabilitation sessions (6 weeks) | Changes in positive and negative affective states as assessed by Positive and Negative Affect Schedule |
| Social cognition | Measured at baseline and at the end the rehabilitation sessions (6 weeks) | Changes in theory of mind ability as assessed by Yoni task-48 |
| Gross manual dexterity level | Measured at baseline and at the end the rehabilitation sessions (6 weeks) | Changes in gross manual dexterity level as assessed by Box and Block |
| Global cognitive functioning | Measured at baseline and at the end the rehabilitation sessions (6 weeks) | Changes in general cognitive funtioning as assessed by MoCA |
| Episodic memory | Measured at baseline and at the end the rehabilitation sessions (6 weeks) | Changes in episodic memory as assessed by FCRST |
Countries
Italy
Outcome results
None listed