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Multimodal Platform Combining VR and TENS for Stroke Rehabilitation - Trial NCT06400823

Access comprehensive clinical trial information for NCT06400823 through Pure Global AI's free database. This phase not specified trial is sponsored by Institute Mihajlo Pupin and is currently Recruiting. The study focuses on Stroke. Target enrollment is 40 participants.

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NCT06400823
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Trial Details
ClinicalTrials.gov โ€ข NCT06400823
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Multimodal Platform Combining VR and TENS for Stroke Rehabilitation

Study Focus

Stroke

VR+TENS

Interventional

other

Sponsor & Location

Institute Mihajlo Pupin

Belgrade, Serbia

Timeline & Enrollment

N/A

Apr 22, 2024

Jun 01, 2026

40 participants

Primary Outcome

Changes in sensorimotor impairments,Changes in functional performances,Changes in body-representation metrics

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 he's touching with the impaired arm.On 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.

ICD-10 Classifications

Stroke, not specified as haemorrhage or infarction
Sequelae of stroke, not specified as haemorrhage or infarction
Cerebral infarction
Family history of stroke
Cerebral infarction, unspecified

Data Source

ClinicalTrials.gov

NCT06400823

Non-Device Trial