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NCT06887231Recruiting

Virtual Reality and Neurostimulation for Early Stroke Rehabilitation

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

Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
35 (estimated)
First submitted
14 Mar 2025
Start date
17 Mar 2025
Primary completion date
30 Nov 2026
Lead sponsor
Medical University of Vienna
Diseases
Stroke
NCT number
NCT06887231

What you commit to

  • Study type: Interventional
  • Planned participants: 35
  • From 17 Mar 2025 to the primary completion date, 30 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pacemaker or other electronic implants

Other illness

  • Other neurological or physical impairment or mental condition that, in the judgment of the investigator, does not allow participation in the study.
  • Epilepsy

Other

  • Mini-Mental State Examination (MMSE) \< 24
  • Nausea, headaches or fatigue due to VR-generated environment ("virtual reality motion sickness")
  • Peripheral nerve damage in the affected arm or hand

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna, Department of Neurology
Coordinator of this site? Confirm its status
ViennaAustriaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.