Virtual Reality and Neurostimulation for Early Stroke Rehabilitation

Официальное название

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

Обзор

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.

Вмешательства

• Другое VR+TENS
  Patients will perform task-oriented movements in an immersive scenario while receiving congruent electrical stimulation. During each session, multiple games will be played, with the type and difficulty calibrated based on the patient's level of impairment.
• Другое Conventional rehabilitation
  Patients will perform dose-matched conventional rehabilitation (aligned with the intervention group), which will include physiotherapy, occupational therapy, and physical therapy.

Первичные конечные точки

• Changes in functional performances [Срок оценки: 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)]
• Changes in sensorimotor impairments [Срок оценки: 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)]
• Changes in upper limb body representation [Срок оценки: 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)]

Вторичные конечные точки (10)

• Changes in degree of assistance required [Срок оценки: 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)]
• Changes in spasticity at hand and elbow level [Срок оценки: 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)]
• Changes in peripersonal space [Срок оценки: 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)]
• Changes in tactile acuity [Срок оценки: 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)]
• Changes in spatial neglect (CBS) [Срок оценки: 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)]
• Changes in spatial neglect (LBT) [Срок оценки: 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)]
• Changes in upper limb kinematics (Velocity) [Срок оценки: Every day, from day 1 to day 14]
• Changes in upper limb kinematics (Smoothness) [Срок оценки: Every day, from day 1 to day 14]
• Changes in upper limb kinematics (Efficiency) [Срок оценки: Every day, from day 1 to day 14]
• Changes in upper limb kinematics (Precision) [Срок оценки: Every day, from day 1 to day 14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• Medical University of Vienna, Department of Neurology — Vienna

Публикации

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31. PMID 1135616
• G. V. Aurucci et al., 'Targeted neural stimulation congruent with immersive reality decreases neuropathic pain - a Randomized Controlled Trial', Dec. 11, 2024, medRxiv. doi: 10.1101/2024.12.10.24318374.
• Aurucci GV, Preatoni G, Damiani A, Raspopovic S. Brain-Computer Interface to Deliver Individualized Multisensory Intervention for Neuropathic Pain. Neurotherapeutics. 2023 Sep;20(5):1316-1329. doi: 10.1007/s13311-023-01396-y. Epub 2023 Jul 5. PMID 37407726
• Bolognini N, Russo C, Edwards DJ. The sensory side of post-stroke motor rehabilitation. Restor Neurol Neurosci. 2016 Apr 11;34(4):571-86. doi: 10.3233/RNN-150606. PMID 27080070
• Perez-Marcos D. Virtual reality experiences, embodiment, videogames and their dimensions in neurorehabilitation. J Neuroeng Rehabil. 2018 Nov 26;15(1):113. doi: 10.1186/s12984-018-0461-0. PMID 30477527
• Hao J, He Z, Yu X, Remis A. Comparison of immersive and non-immersive virtual reality for upper extremity functional recovery in patients with stroke: a systematic review and network meta-analysis. Neurol Sci. 2023 Aug;44(8):2679-2697. doi: 10.1007/s10072-023-06742-8. Epub 2023 Mar 23. PMID 36959332
• Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4. PMID 29156493
• Chen Y, Abel KT, Janecek JT, Chen Y, Zheng K, Cramer SC. Home-based technologies for stroke rehabilitation: A systematic review. Int J Med Inform. 2019 Mar;123:11-22. doi: 10.1016/j.ijmedinf.2018.12.001. Epub 2018 Dec 11. PMID 30654899

Идентификаторы

NCT: NCT06887231 · 2280/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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