Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400823
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-19
Brief Title:
Multimodal Platform Combining VR and TENS for Stroke Rehabilitation
Sponsor:
Institute Mihajlo Pupin
Organization:
Institute Mihajlo Pupin
Study Overview
Official Title:
Multimodal Platform Combining VR and TENS for Stroke Rehabilitation
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Stroke is a disabling medical condition annually affecting up to 15 million people worldwide It leads to upper-limb impairments encompassing motor and sensory deficits together with cognitive self-body and space misrepresentation overall limiting the functional independence of 70 of stroke survivors On the motor side stroke could account for hemiparesis weakness or paralysis affecting the side contralateral to the brain lesion muscle weakness spasticity loss of coordination and others On the sensory side especially in the first stages after the stroke occurs stroke could account for sensory loss with the patient not being able to perceive what hes touching with the impaired armOn a cognitive level it has been shown that chronic stroke patients have distorted body representation and space representation They perceive their impaired arm as shorter and the impaired hand as larger
Despite initial evidence of the crucial role of sensory-motor integration toward a restored body representation to promote effective rehabilitation conventional approaches suffer from the bias of prioritizing motor recovery while disregarding stroke-induced sensory and body representation deficits
In this view the creation of a virtual reality VR scenario in which the person is fully immersed could potentially play a significant role in improving stroke patients rehabilitation
Taking this into consideration this project aims to assess whether a multimodal platform combining VR with TENS inducing full-body illusion toward a virtual avatar could positively impact motor performances sensory assessments and self-body and space representation of stroke patients
More into detail the intervention will consist of the patient performing some task-oriented movement within the virtual reality and congruently tactile receiving feedback through transcutaneous electrical nerve stimulation The subject will receive clear instruction within the virtual reality scenario to perform specific actions toward a final goal These actions will be designed to make the subject repeat some crucial movements in their rehabilitation process Depending on the motor impairment of the patient the investigators will adapt the characteristics and the difficulty of the task accordingly
Despite initial evidence of the crucial role of sensory-motor integration toward a restored body representation to promote effective rehabilitation conventional approaches suffer from the bias of prioritizing motor recovery while disregarding stroke-induced sensory and body representation deficits
In this view the creation of a virtual reality VR scenario in which the person is fully immersed could potentially play a significant role in improving stroke patients rehabilitation
Taking this into consideration this project aims to assess whether a multimodal platform combining VR with TENS inducing full-body illusion toward a virtual avatar could positively impact motor performances sensory assessments and self-body and space representation of stroke patients
More into detail the intervention will consist of the patient performing some task-oriented movement within the virtual reality and congruently tactile receiving feedback through transcutaneous electrical nerve stimulation The subject will receive clear instruction within the virtual reality scenario to perform specific actions toward a final goal These actions will be designed to make the subject repeat some crucial movements in their rehabilitation process Depending on the motor impairment of the patient the investigators will adapt the characteristics and the difficulty of the task accordingly
Detailed Description:
None
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