Virtual Reality and Neurostimulation for Early Stroke Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06887231
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Study Start: 2025-03-17
• Study First Posted: 2025-03-20
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-11-30
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in functional performances	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)	To assess functional performance of the upper extremity through observational means the investigators will use the Action Research Arm Test (ARAT). The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score goes from 0 to 57. Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test.
Changes in sensorimotor impairments	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)	To assess the sensorimotor impairment in individuals who have had a stroke the investigators will use Fugl-Meyer for upper extremity (FMUE). FMUE assesses reflex activity, movement control, muscle strength, and sensory performances. It comprises items scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Changes in upper limb body representation	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)	To measure the body representation of the subjects the investigators will use body-landmark metric. In VR, the subject is asked to locate the position of specific body landmarks (e.g. elbow, inner wrist, outer wrist, index, ring) describing the proportion of patients' arm while a black panel is on top of his/her arm. The investigators will then compare the real and perceived dimension of patients' arm

Secondary Outcome Measures

Name	Time	Method
Changes in degree of assistance required	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)	To assess the degree of assistance required by an individual on ten mobility and self-care the investigators will use the Barthel Index. The score goes from 0 to 100. It consists of an ordinal scale which measures a person's ability to complete activities of daily living (ADL)
Changes in spasticity at hand and elbow level	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)	The investigators will use Modified Ashworth Scale to test resistance to passive movement about a joint with varying degrees of velocity. This test is performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met).
Changes in peripersonal space	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)	To measure the peri-personal space of stroke patients (the space in which multisensory integration is enhanced). Test Performance: In VR, the subject is sitting on a table and sees balls approaching him. He/she's asked to press a controller whenever he/she feels electrical stimulation.
Changes in tactile acuity	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)	To measure the tactile acuity of patients we will use the Two-Point discrimination test. While blindfolded, the patient is repetitively touched with either one or two pins (fixed distance) and he asked to tell how many pins he/she feels.
Changes in spatial neglect (CBS)	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)	To measure spatial neglect, participants will be assessed using the Catherine Bergego Scale, which comprises 10 everyday tasks observed during self-care activities. A therapist scores the patient on behaviors such as neglecting the left side of the body and difficulties in grooming, eating, movement, and spatial awareness. The CBS uses a 4-point scale (0-3) to rate neglect severity, with a total score of 30.
Changes in spatial neglect (LBT)	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)	To measure spatial neglect, patients will perform a line bisection test. The Line Bisection Test is a test is a quick measure to detect the presence of unilateral spatial neglect (USN). To complete the test, one must place a mark with a pencil through the center of a series of horizontal lines. Usually, a displacement of the bisection mark towards the side of the brain lesion is interpreted as a symptom of neglect.
Changes in upper limb kinematics (Velocity)	Every day, from day 1 to day 14	To assess changes in velocity the investigators will measure kinematic velocity of the patients while performing rehabilitation tasks.
Changes in upper limb kinematics (Smoothness)	Every day, from day 1 to day 14	To assess changes in smoothness the investigators will measure kinematic smoothness of the patients while performing rehabilitation tasks.
Changes in upper limb kinematics (Efficiency)	Every day, from day 1 to day 14	To assess changes in efficiency the investigators will measure the amount and rate of task-oriented movements of the patients.
Changes in upper limb kinematics (Precision)	Every day, from day 1 to day 14	To assess changes in precision the investigators will measure the spatial precision (error with respect to a predefined correct movement) during the task-oriented movements of the patient.

Trial Locations

Locations (1)

Medical University of Vienna, Department of Neurology; 🇦🇹 Vienna, Austria