Multimodal Platform Combining VR and TENS for Stroke Rehabilitation

Institute Mihajlo Pupin

Status: Enrolling

Conditions: Stroke

Treatments: Other: VR+TENS; Other: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06400823

VRTENSSTROKE

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic or haemorrhagic stroke patient
• At least 3 months after the stroke incident
• 10 <= FMUE <= 60 (motor function)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

VR+TENS

Experimental group

Description:

Patients will undergo goal-oriented movements for upper-limb rehabilitation in a VR scenario. While performing the movement, patients will receive synchronous electrical stimulation targeting the medial nerve. The provided sensation will stimulate the interaction with elements in the virtual world. The intervention phase will last 3 weeks. Patients will undergo a minimum of three sessions per week (of around 60'). During each of these sessions, the first 10' will be employed for the calibration of the Transcutaneous Electrical Nerve Stimulation (TENS). In the remaining part of the session, subjects will perform some of the VR-based task-oriented games targeting different components.

Treatment:

Other: VR+TENS

Conventional rehabilitation

Active Comparator group

Description:

Patients in the control group will perform physical conventional rehabilitation provided by the rehabilitation clinic. The total amount of therapy will be the same as that of the VR+TENS group. The exercises will target the same components of the VR+TENS arm.

Treatment:

Other: Conventional rehabilitation