Virtual Reality (VR) Platform and Transcutaneous Electrical Nerve Stimulation (TENS) for Early Stroke Rehabilitation

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna, Department of Neurology
RECRUITING
Vienna
Contact Information
Primary
Andrea Cimolato, PhD
andrea.cimolato@meduniwien.ac.at
+4314040039224
Backup
Anna Sparapani, MSc
anna.sparapani@meduniwien.ac.at
+4314040039224
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 35
Treatments
Experimental: VR+TENS
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.
Active_comparator: Conventional Rehabilitation
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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov