Pimenta Silva Daniela, Pona-Ferreira Filipa, Santos Beatriz, Campo-Prieto Pablo, Bouça-Machado Raquel, Ferreira Joaquim J
Centro de Estudos Egas Moniz, Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisbon, Portugal.
Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisbon, Portugal.
Sensors (Basel). 2024 Dec 22;24(24):8188. doi: 10.3390/s24248188.
Virtual reality (VR) has been used in research and clinical practice in the management of Parkinson's disease (PD), potentially enhancing physiotherapy. Adverse events (AEs) associated with VR applications in PD have been poorly explored. We conducted a randomized controlled trial to compare two 12-week interventions using physiotherapy and immersive VR, and analyzed the frequency and type of AEs occurring in 30 people with PD. We reported 144 AEs (8.4% of the sessions), predominantly classified as mild and unrelated to the interventions. Two were serious AEs, one leading to study discontinuation. Notably, discomfort/pain, motor fluctuations, and falls were the most frequently reported, accounting for 63% of the total AEs. Five falls were definitely associated with the 'sense of presence' provided by the fully immersive VR system, which underscores the necessity for careful game selection when designing interventions for PD. Motor fluctuations may have been associated with various factors, which merit further investigation. We also explored the role of SSQ as a measure of cybersickness in PD. In conclusion, it is important to closely monitor and characterize AEs to ensure safety and efficacy in clinical practice as AEs may be more common than previously recognized in VR interventions in PD.
虚拟现实（VR）已被用于帕金森病（PD）管理的研究和临床实践中，可能会增强物理治疗效果。与VR应用于PD相关的不良事件（AE）尚未得到充分探索。我们进行了一项随机对照试验，比较了使用物理治疗和沉浸式VR的两种为期12周的干预措施，并分析了30名PD患者中发生的AE的频率和类型。我们报告了144起AE（占疗程的8.4%），主要分类为轻度且与干预措施无关。有两起是严重AE，其中一起导致研究中止。值得注意的是，不适/疼痛、运动波动和跌倒的报告最为频繁，占AE总数的63%。有五次跌倒肯定与完全沉浸式VR系统提供的“临场感”有关，这突出了在为PD设计干预措施时谨慎选择游戏的必要性。运动波动可能与多种因素有关，值得进一步研究。我们还探讨了SSQ作为PD中晕动病测量指标的作用。总之，密切监测和描述AE对于确保临床实践中的安全性和有效性很重要，因为在PD的VR干预中，AE可能比以前认识到的更为常见。
