Motor and Cognitive Telerehabilitation in a Virtual Environment in Patients With Post-stroke Sequelae and Parkinson's Disease

Официальное название

Telerehabilitation in a Virtual Environment for Sensorimotor and Cognitive Recovery in Patients With Post-stroke Sequelae and Parkinson's Disease: a Pilot Study

Обзор

The goal of this interventional pilot trial is to evaluate whether a telerehabilitation protocol based on immersive virtual reality (VR) is effective and feasible for the recovery of cognitive and/or motor functions in patients with sequelae of ischemic or hemorrhagic stroke or with Parkinson's disease. The main questions it aims to answer are: * Does the VR-based telerehabilitation protocol improve cognitive and/or motor outcomes compared to conventional rehabilitation? * Is the protocol feasible, defined as ≥80% adherence among participants? Is the system acceptable and user-friendly from the patient's perspective? Researchers will compare an interventional arm receiving telerehabilitation via an immersive VR home kit with a control arm receiving conventional rehabilitation according to standard clinical practice. Both groups will receive the same number of sessions, with the same duration and weekly frequency. Outcomes will be assessed at baseline (T0), after 4 weeks of treatment (T1), and at 3-month follow-up (T2).

Подробное описание

Telerehabilitation (TR) is defined as the remote delivery of rehabilitation services through telecommunications technologies. It offers particular advantages for patients with neurological disabilities who require continuous and personalized rehabilitation training, enabling flexible treatment protocols and ongoing clinical-functional monitoring, especially for those residing in remote areas or with limited mobility.

Immersive virtual reality (VR) represents a highly engaging environment in which multiple forms of sensory feedback-auditory, visual, and tactile-can be organized to activate cortical and subcortical neural structures, thereby promoting functional and structural recovery. Evidence on neuroplasticity suggests that immersive VR systems may represent a key element in rehabilitation programs by enhancing motor learning capacity. Through specialized devices, it is possible to recreate and simulate actions in an immersive virtual environment, allowing patients to experience safe and realistic scenarios with real-time responses to stimuli, eliciting physiological and neural activation comparable to real-world experiences.

In patients with stroke sequelae or Parkinson's disease, the combination of TR and immersive VR-compared to conventional therapeutic approaches-allows for interactive, task-specific treatment adapted to individual patient characteristics, delivered over extended periods with adequate patient engagement. This approach may have a positive neuropsychological impact in terms of disability acceptance and usability, improving functional outcomes and quality of life.

The experimental treatment group will perform a personalized cognitive and/or motor rehabilitation protocol using a certified Home Kit including an immersive VR headset, already employed in clinical practice at the coordinating center. After three in-person sessions for technology familiarization, patients will use the Home Kit at home for 50 minutes per day, 5 days per week, asynchronously, with one weekly synchronous session via videoconferencing with the therapist. Continuous remote monitoring of outcomes and timely adjustment of parameters will be ensured throughout the 4-week treatment period.

The control group will receive cognitive and/or motor rehabilitation according to standard clinical practice (individual rehabilitation program, 50-minute sessions, 5 days per week for 4 weeks).

Randomization will be performed by an external collaborator not involved in patient assessment or treatment, using a pre-generated randomization list to ensure allocation concealment.

Patients will be assessed at baseline (T0), at the end of the 4-week treatment (T1), and at 3-month follow-up (T2) using standardized clinical scales evaluating balance, fall risk, walking ability, upper limb impairment, activities of daily living, memory and attention, and quality of life. Acceptability and usability of the VR telerehabilitation system will be assessed at T1 in the experimental group only.

Вмешательства

• Другое VR-based Telerehabilitation with Home Kit
  The proposed intervention uses a certified Home Kit - inclusive of an immersive VR headset - already employed in clinical practice at the coordinating center (IRCCS ISNB, Bologna). The rehabilitation team (physician, speech therapist, physiotherapist) defines an individualized protocol for cognitive and/or motor recovery. The first 3 sessions are conducted in-person to allow technology familiarization. Patients then use the Home Kit at home for 50 minutes/day, 5 days/week, for 4 weeks, in asynch
• Другое Standard Rehabilitation (Conventional Care)
  Patients in the control group receive cognitive and/or motor rehabilitation according to standard clinical practice, as defined by the individual rehabilitation project. Sessions last 50 minutes, are delivered 5 days per week, for 4 weeks, and are conducted in person at the rehabilitation unit. No virtual reality or telerehabilitation technology is used in this arm.

Первичные конечные точки

• Adherence rate to the telerehabilitation protocol [Срок оценки: End of treatment (T1, Week 4)]

Вторичные конечные точки (12)

• Berg Balance Scale (BBS) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Timed Up and Go Test (TUG) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Falls Efficacy Scale (FES) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• 10-Meter Walk Test (10-MWT) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• 6-Minute Walk Test (6-MWT) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Barthel Index (BI) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Trail Making Test (TMT) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• 15-Word Memory Test (15-WMT) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Corsi Span Test (CS) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Digit Span Test (DS) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]
• Short Form Health Survey-36 (SF-36) [Срок оценки: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)]

Критерии участия

Критерии включения

• Age >18 years old, both sex;
• stroke or Parkinson diagnosis > or = 2 months;
• upper limb impairment
• informed consent signed

Критерии исключения

• ongoing clinical instability;
• important cognitive impairment;
• psychiatric, neurological, or internal medicine comorbidities;
• severe rigidity or hypertonia;
• severe visual deficit;
• pregnancy women

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

Организация здравоохранения

Центры проведения

Италия · 1 центр

• IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna — Bologna

Публикации

• Marin-Medina DS, Arenas-Vargas PA, Arias-Botero JC, Gomez-Vasquez M, Jaramillo-Lopez MF, Gaspar-Toro JM. New approaches to recovery after stroke. Neurol Sci. 2024 Jan;45(1):55-63. doi: 10.1007/s10072-023-07012-3. Epub 2023 Sep 11. PMID 37697027
• Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455. PMID 31165721
• Kwon SH, Park JK, Koh YH. A systematic review and meta-analysis on the effect of virtual reality-based rehabilitation for people with Parkinson's disease. J Neuroeng Rehabil. 2023 Jul 20;20(1):94. doi: 10.1186/s12984-023-01219-3. PMID 37475014
• Cano Porras D, Siemonsma P, Inzelberg R, Zeilig G, Plotnik M. Advantages of virtual reality in the rehabilitation of balance and gait: Systematic review. Neurology. 2018 May 29;90(22):1017-1025. doi: 10.1212/WNL.0000000000005603. Epub 2018 May 2. PMID 29720544
• Alashram AR, Annino G, Padua E, Romagnoli C, Mercuri NB. Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. J Clin Neurosci. 2019 Aug;66:209-219. doi: 10.1016/j.jocn.2019.04.026. Epub 2019 May 10. PMID 31085075
• Aida J, Chau B, Dunn J. Immersive virtual reality in traumatic brain injury rehabilitation: A literature review. NeuroRehabilitation. 2018;42(4):441-448. doi: 10.3233/NRE-172361. PMID 29660958
• Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016. PMID 27124611
• De Luca R, Maggio MG, Naro A, Portaro S, Cannavo A, Calabro RS. Can patients with severe traumatic brain injury be trained with cognitive telerehabilitation? An inpatient feasibility and usability study. J Clin Neurosci. 2020 Sep;79:246-250. doi: 10.1016/j.jocn.2020.07.063. Epub 2020 Aug 17. PMID 33070905

Идентификаторы

NCT: NCT07582497 · HOMEVIRTUAL REHAB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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