Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474871
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-14
Brief Title:
Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury
Sponsor:
Anna Estraneo
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Multicentric Study on Implementation of Virtual Reality for Rehabilitation of Cognitive Functions in Patients With Severe Acquired Brain Injury a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-sABI
Brief Summary:
Considerable evidence exists for using Virtual Reality VR for rehabilitation of acquired brain injury ABI with a particular focus on stroke However to date very little evidence has been collected in patients with ABI with different aetiologies ie traumatic or anoxic brain injury and level of severity ie severe sABI The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes small sample sizes and a lack of randomized controlled trials which can affect the level of evidence and generalizability of results to determine the effectiveness of a non immersive VR-based rehabilitation versus traditional cognitive training TCT
Detailed Description:
Background Virtual Reality VR refers to a computer-generated digital environment that can be experienced and interacted with as if that environment were real VR systems are typically classified as immersive semi-immersive or non-immersive with immersion referring to the level of user perception with regard to being in a virtual environment VE rather than the real world immersive VR systems supply VEs with a changing field of view via head-mounted displays and in which movement is achieved via hardware such as head trackers hand controllers and body motion sensors semi-immersive VR refers to systems that use projection-based systems eg driving simulators and use of shutter glasses non-immersive VR systems include basic desktop displays and videogames
Considerable evidence exists for using VR for rehabilitation of acquired brain injury ABI with a particular focus on stroke The benefits of VR for ABI rehabilitation seem to include enhanced ecological validity the ability to maintain experimental control over assessment and treatment standardization and the control of task complexity Indeed VR can provide relatively naturalistic VEs for repeated practice of functional tasks such as activities of instrumental daily living which may assist with generalizing targeted skills VR can also enhance patient motivation and active participation thanks to visual and auditory feedback which is necessary for neurorehabilitation Furthermore VR tools offer the possibility to adapt the exercises to the patients capabilities and needs and monitor their performance
However to date very little evidence has been collected in patients with ABI with different aetiologies ie traumatic or anoxic brain injury and level of severity ie sABI Moreover current evidence provides some support for using VR for ABI rehabilitation but the quality of the evidence is relatively low and many studies include non-immersive and semi-immersive systems rather than focusing on immersive VR technology For instance a recent study44 investigated the effects of non-immersive VR-based training to improve executive abilities in patients with moderate to severe traumatic brain injury TBI Executive dysfunction is among the most common facets of cognitive impairment following TBI involving about 48 of moderate-to-severe TBI patients Patients received either the standard cognitive training ie paper and pencil or the VR-based cognitive training The authors found that all patients improved their global cognitive and executive function even though those treated with VR achieved better outcomes44 Although this study showed that VR cognitive rehabilitation can be a promising tool to improve executive functions further studies are needed to confirm the value of VR in sABI The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes small sample sizes and a lack of randomized controlled trials which can affect the level of evidence and generalizability of results
Methods Study type interventional Allocation randomized Intervention model parallel assignment 11 28 patients will be randomly assigned to receive either 30 minutes of VR or TCT sessions at the same time each day throughout the experiment 20 VR or TCT sessions will be applied 5 per week for 5 weeks Both groups will receive an additional 60 minute-comprehensive daily rehabilitation programme in the 3 months of the study This programme consists of active limb mobilization training on different cognitive domains occupational therapy language and swallowing therapy based on the patients functional condition
Primary endpoint
-B-A score of the Trail Making Test TMT according to normative data adjusted for age and education Siciliano et al 2019
Secondary endpoints
Total score on the Disability Rating Scale
System usability scale SUS for evaluating the Usability of VR in patients and professionals
modified Barthel Index mBI for functional disability Exploratory endpoints T-otal score on the Italian version of the NeuroPsychiatric Inventory
Quantitative EEG
Blood biomarkers BDNF NFL GFAP
Level of Cognitive Functioning
Total score on the Galveston Orientation and Amnesia Test
Scores on the Broken Hearts task overall accuracy andor Trails task baseline and shifting scores on the Italian version of the Oxford Cognitive Screening
Adverse Events Report emptinessdisorientation nauseafeeling of emptiness headache disorientation dizziness tremorsnauseablurred visiondizziness nausea vertigo and sense of unreality will also be collected weekly in both groups from enrolment through termination of study protocol
Considerable evidence exists for using VR for rehabilitation of acquired brain injury ABI with a particular focus on stroke The benefits of VR for ABI rehabilitation seem to include enhanced ecological validity the ability to maintain experimental control over assessment and treatment standardization and the control of task complexity Indeed VR can provide relatively naturalistic VEs for repeated practice of functional tasks such as activities of instrumental daily living which may assist with generalizing targeted skills VR can also enhance patient motivation and active participation thanks to visual and auditory feedback which is necessary for neurorehabilitation Furthermore VR tools offer the possibility to adapt the exercises to the patients capabilities and needs and monitor their performance
However to date very little evidence has been collected in patients with ABI with different aetiologies ie traumatic or anoxic brain injury and level of severity ie sABI Moreover current evidence provides some support for using VR for ABI rehabilitation but the quality of the evidence is relatively low and many studies include non-immersive and semi-immersive systems rather than focusing on immersive VR technology For instance a recent study44 investigated the effects of non-immersive VR-based training to improve executive abilities in patients with moderate to severe traumatic brain injury TBI Executive dysfunction is among the most common facets of cognitive impairment following TBI involving about 48 of moderate-to-severe TBI patients Patients received either the standard cognitive training ie paper and pencil or the VR-based cognitive training The authors found that all patients improved their global cognitive and executive function even though those treated with VR achieved better outcomes44 Although this study showed that VR cognitive rehabilitation can be a promising tool to improve executive functions further studies are needed to confirm the value of VR in sABI The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes small sample sizes and a lack of randomized controlled trials which can affect the level of evidence and generalizability of results
Methods Study type interventional Allocation randomized Intervention model parallel assignment 11 28 patients will be randomly assigned to receive either 30 minutes of VR or TCT sessions at the same time each day throughout the experiment 20 VR or TCT sessions will be applied 5 per week for 5 weeks Both groups will receive an additional 60 minute-comprehensive daily rehabilitation programme in the 3 months of the study This programme consists of active limb mobilization training on different cognitive domains occupational therapy language and swallowing therapy based on the patients functional condition
Primary endpoint
-B-A score of the Trail Making Test TMT according to normative data adjusted for age and education Siciliano et al 2019
Secondary endpoints
Total score on the Disability Rating Scale
System usability scale SUS for evaluating the Usability of VR in patients and professionals
modified Barthel Index mBI for functional disability Exploratory endpoints T-otal score on the Italian version of the NeuroPsychiatric Inventory
Quantitative EEG
Blood biomarkers BDNF NFL GFAP
Level of Cognitive Functioning
Total score on the Galveston Orientation and Amnesia Test
Scores on the Broken Hearts task overall accuracy andor Trails task baseline and shifting scores on the Italian version of the Oxford Cognitive Screening
Adverse Events Report emptinessdisorientation nauseafeeling of emptiness headache disorientation dizziness tremorsnauseablurred visiondizziness nausea vertigo and sense of unreality will also be collected weekly in both groups from enrolment through termination of study protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None