一项改善儿童和青少年偏视并发脑肿瘤患者视觉感知的远程康复计划:单臂可行性和概念验证试验。

IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-11-29 eCollection Date: 2024-12-01 DOI:10.1016/j.eclinm.2024.102955
Mariana Misawa, Inci Yaman Bajin, Bill Zhang, Monica Daibert-Nido, Danielle Tchao, Eduardo Garcia-Giler, Kyle Cheung, Lora Appel, Pi Nasir, Arun Reginald, Uri Tabori, Ute Bartels, Vijay Ramaswamy, Samuel N Markowitz, Eric Bouffet, Michael Reber
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引用次数: 0

摘要

背景:儿童脑肿瘤可导致偏视,即意识视力丧失,严重影响儿童的发育和生活质量,但目前尚无有效的干预措施。本研究旨在探讨沉浸式虚拟现实(3D-MOT-IVR)中基于家庭的视听刺激改善视觉功能和功能视觉的可行性、安全性和潜在有效性。方法:在2022年7月至2023年10月进行的一项2a期、开放标记、非随机、单臂研究(NCT05065268)中,10名患有稳定性偏盲的儿童和青少年被招募,每隔一天在家中进行20分钟的3D-MOT-IVR治疗,持续6周。我们通过监测采用率、依从性和完成率、远程数据传输和定性反馈来评估可行性。使用有效的晕屏问卷对安全性进行评估。在干预前和干预后按照标准化低视力评估程序进行全面的视力评估,并在1个月和6个月进行随访。结果:基于家庭的3D-MOT-IVR干预被证明是可行和安全的,没有报告的不良事件。所有参与者均完成了规定的刺激和干预前后的评估点,90%的参与者完成了随访。十名参与者中有九名在视觉功能和/或功能性视力方面表现出临床意义上的增强,即双目视野恢复和阅读速度加快,但两名参与者同时表现出单眼视野恶化。这些积极的影响在6个月的随访中得以维持。探索性结果显示,3D-MOT-IVR干预的表现与双眼视野测试的视觉感知之间存在显著的正相关。解释:我们的研究结果强调了沉浸式虚拟现实中基于家庭的视听刺激作为一种潜在的干预措施的可行性和安全性,可以改善儿童/青少年偏视伴儿童脑肿瘤患者的视觉感知。这些有希望的结果为更大规模的随机对照试验奠定了坚实的基础,为这一弱势群体的视力康复带来了有意义的突破。资助:Meagan Bebenek基金会和大学健康网络基金会。
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A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumor: a single-arm feasibility and proof-of-concept trial.

Background: Brain tumor in children can induce hemianopia, a loss of conscious vision, profoundly impacting their development and quality of life, yet no effective intervention exists for this pediatric population. This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT-IVR) to improve visual function and functional vision.

Methods: In a phase 2a, open-labeled, nonrandomized, single-arm study, conducted from July 2022 to October 2023 (NCT05065268), 10 children and adolescents with stable hemianopia were enrolled to perform 20-min sessions of 3D-MOT-IVR every other day for six weeks from home. We assessed feasibility by monitoring adoption, adherence and completion rates, remote data transfer and qualitative feedback. Safety was evaluated using validated cybersickness questionnaires. Comprehensive vision assessments following standardized low-vision evaluation procedures were conducted pre- and post-intervention, with follow-ups at 1- and 6 months.

Findings: The home-based 3D-MOT-IVR intervention proved both feasible and safe, with no reported adverse events. All participants completed the prescribed stimulations and the pre- and post-intervention assessment points, 90% completed the follow-ups. Nine out of ten participants showed clinically meaningful enhancement in visual function and/or functional vision, namely binocular visual field restoration and increased reading speed, but two showed concomitant deterioration in monocular visual field. These positive effects were sustained at the 6-month follow-up. Exploratory outcomes revealed a significant positive correlation between the performance at the 3D-MOT-IVR intervention and the visual perception at the binocular visual field test.

Interpretation: Our findings underscore the feasibility and safety of home-based audiovisual stimulation in immersive virtual-reality as a potential intervention for improving visual perception in children/adolescents with hemianopia consecutive to a pediatric brain tumor. These promising results lay a strong foundation for a larger randomized controlled trial, offering hope for a meaningful breakthrough in visual rehabilitation for this vulnerable population.

Funding: Meagan Bebenek Foundation and University Health Network Foundation.

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来源期刊
EClinicalMedicine
EClinicalMedicine Medicine-Medicine (all)
CiteScore
18.90
自引率
1.30%
发文量
506
审稿时长
22 days
期刊介绍: eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
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