Clinical trial NCT06887231: Virtual Reality and Neurostimulation for Early Stroke Rehabilitation
Official title: Virtual Reality (VR) Platform and Transcutaneous Electrical Nerve Stimulation (TENS) for Early Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Virtual Reality
Transcutaneous Electrical Nerve Stimulation
Multisensory integration
Task oriented movement
Rehabilitation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Changes in functional performances
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in sensorimotor impairments
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in upper limb body representation
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Secondary outcomes:
measure: Changes in degree of assistance required
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in spasticity at hand and elbow level
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in peripersonal space
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in tactile acuity
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in spatial neglect (CBS)
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in spatial neglect (LBT)
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in upper limb kinematics (Velocity)
timeFrame: Every day, from day 1 to day 14
measure: Changes in upper limb kinematics (Smoothness)
timeFrame: Every day, from day 1 to day 14
measure: Changes in upper limb kinematics (Efficiency)
timeFrame: Every day, from day 1 to day 14
measure: Changes in upper limb kinematics (Precision)
timeFrame: Every day, from day 1 to day 14
Other outcomes:
measure: Changes in pain
timeFrame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Treatment Satisfaction
timeFrame: 3 weeks (one day after the last rehabilitation session, T2)
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Neurology
Study officials:
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