Virtual Reality and Neurostimulation for Early Stroke Rehabilitation (VR-TENS)

Medical University of Vienna

Status: Enrolling

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06887231

2280/2024

Details and patient eligibility

About

Stroke is one of the leading causes of disability, leaving millions of individuals each year impaired with lasting motor and sensory impairments. In the subacute phase, which goes from the first week to 3 months post-stroke, the patient has the highest recovery, which could be boosted by proper technologies intended for the rehabilitation of the patients. The impairments that the patients experience are extremely heterogeneous and go from muscle weakness to spasticity of the paretic side of the body. Beyond motor deficits, stroke survivors also suffer from sensory impairment (they do not properly feel with the paretic side of their body), impaired body representation (misjudging the size, position, and movement of their affected limb), which can further hinder recovery.

Traditional rehabilitation primarily targets motor function, often without considering at all the role of sensory feedback and body perception in the recovery process. However, growing evidence suggests that the combination of multiple sensory modalities towards a multifaceted rehabilitation can enhance neuroplasticity and improve rehabilitation outcomes.

To address this, the investigators have developed a novel rehabilitation approach that integrates immersive virtual reality (VR) with transcutaneous electrical nerve stimulation (TENS). This system allows stroke patients to interact with a virtual environment while receiving synchronized tactile stimulation, reinforcing sensorimotor integration. Unlike conventional therapy, which relies on passive or repetitive exercises, this approach engages patients in active, goal-oriented movements, tailored to their individual recovery progress.

By focusing on the subacute stroke population, this project aims to leverage the brain's heightened plasticity during early recovery to maximize functional improvements. The VR-based intervention will adapt to each patient's motor abilities, providing real-time feedback to encourage precise movements and enhance sensory processing. Through this multisensory experience, the investigators seek to improve not only motor control but also sensory and body representation measures.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of ischemic or hemorrhagic stroke
• In the subacute phase (from 7 days to 3 months from last stroke onset)
• Fugl-Meyer-Upper Extremity (FMUE) scale for the motor part: FMUE ≥ 10
• Ability to sit in an upright position
• Age between 18 and 80 years

Exclusion criteria

• Other neurological or physical impairment or mental condition that, in the judgment of the investigator, does not allow participation in the study.
• Mini-Mental State Examination (MMSE) < 24
• Epilepsy
• Nausea, headaches or fatigue due to VR-generated environment ("virtual reality motion sickness")
• Peripheral nerve damage in the affected arm or hand
• Pacemaker or other electronic implants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

VR+TENS

Experimental group

Description:

Patients will engage in goal-directed upper-limb rehabilitation exercises within a virtual reality environment. During these exercises, they will receive synchronized electrical stimulation targeting the median nerve. The intervention phase will span three weeks, with patients participating in at least three sessions per week, each lasting approximately 60 minutes.

Treatment:

Other: VR+TENS

Conventional Rehabilitation

Active Comparator group

Description:

Participants will undergo the same therapy duration, engaging in conventional physiotherapy, occupational therapy, or physical therapy. Exercises and movements will be designed to align with those in the experimental group.

Treatment:

Other: Conventional rehabilitation