Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06400823

Multimodal Platform Combining VR and TENS for Stroke Rehabilitation

Led by Institute Mihajlo Pupin · Updated on 2024-12-09

40

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

I

Institute Mihajlo Pupin

Lead Sponsor

E

ETH Zurich (Switzerland)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Multimodal Platform Combining VR and TENS for Stroke Rehabilitation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ischemic or haemorrhagic stroke patient
  • At least 3 months after the stroke incident
  • Motor function score (FMUE) between 10 and 60
Not Eligible

You will not qualify if you...

  • Prior neurological or psychiatric disorders
  • Severe cognitive impairment (MoCA score less than 10)
  • Epilepsy
  • Pacemakers or other electronic implants
  • Unable to give informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinic for rehabilitation dr Miroslav Zotovic

Belgrade, Serbia

Actively Recruiting

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Research Team

N

Natalija Secerovic, PhD

CONTACT

G

Giuseppe Valerio Aurucci

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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