远程康复对严重获得性脑损伤患者的益处:使用非沉浸式虚拟现实技术的多中心随机对照试验的可喜结果。
Benefits of Telerehabilitation for Patients With Severe Acquired Brain Injury: Promising Results From a Multicenter Randomized Controlled Trial Using Nonimmersive Virtual Reality.
机构信息
Istituto di Ricovero e Cura a Carattere Scientifico Centro Neurolesi Bonino Pulejo, Messina, Italy.
Laboratory of Healthcare Innovation Technology, Istituto di Ricovero e Cura a Carattere Scientifico San Camillo Hospital, Venezia, Italy.
出版信息
J Med Internet Res. 2023 Aug 21;25:e45458. doi: 10.2196/45458.
BACKGROUND
In neurorehabilitation, the use of innovative technologies offers many opportunities to monitor and improve the health status of patients with severe acquired brain injury (SABI). Telerehabilitation allows for continuity of service through the entire rehabilitation cycle, including assessment, intervention, consultation, and education, affording early reintegration and positively enhancing the quality of life (QoL).
OBJECTIVE
The main purpose of this multicenter randomized controlled trial was to test the effectiveness of advanced training provided using a nonimmersive virtual reality rehabilitation system (ie, the VRRS HomeKit device) in improving functional outcomes in patients with SABI.
METHODS
In total, 40 patients with SABI and their 40 caregivers visiting 2 Italian rehabilitation centers were enrolled in the study protocol and randomized into 2 groups. Of the 40 patients, 20 (50%) underwent the experimental training using the VRRS HomeKit (teleneuro-VRRS group), whereas the other 20 (50%) were administered usual territorial rehabilitative treatments (UTRTs; control group). To investigate motor and neuropsychological functioning, patients with SABI were evaluated before (T0) and at the end of (T1) each training session by a multispecialist team through a complete clinical and psychometric battery: the Barthel Index (BI), the Tinetti Scale (TS), the Modified Ashworth Scale (MAS), the Montreal Cognitive Assessment (MoCa), the Frontal Assessment Battery (FAB), the Beck Depression Inventory II (BDI-II), the Short Form Health Survey 36 (SF-36), and the Psychological General Well-Being Index (PGWBI). In addition, the Caregiver Burden Inventory (CBI) was administered to each caregiver to investigate the emotional burden status.
RESULTS
The teleneuro-VRRS group achieved a statistically significant improvement in both general and motor outcomes, as well as psychological well-being and QoL, compared to the control group. In particular, the BI (P<.001), FAB (P<.001), and BDI-II (P<.001) were the outcome scales with the best improvement. The burden of caregivers also significantly improved in the teleneuro-VRRS group (CBI; P<.004). Between-group analysis showed statistical differences in the anxiety (effect size [ES]=0.85, P<.02) and self-control (ES=0.40, P<.03) subtests of the PGWBI and in the social role functioning (ES=0.85, P<.02) subtest of the SF-36, confirmed by quite medium and large ESs.
CONCLUSIONS
Our results suggest that the VRRS is a suitable alternative tool or complementary tool or both to improve motor (level of functional independence) and cognitive (frontal/executive abilities) outcomes, reducing behavioral alterations (anxiety and depression symptoms) in patients with SABI, with a beneficial impact also on the caregivers' burden distress management, mitigating distress and promoting positive aspects of caring.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03709875; https://classic.clinicaltrials.gov/ct2/show/NCT03709875.
背景
在神经康复中,创新技术的应用为监测和改善严重获得性脑损伤(SABI)患者的健康状况提供了许多机会。远程康复允许通过整个康复周期提供连续性服务,包括评估、干预、咨询和教育,实现早期重新融入,并积极提高生活质量(QoL)。
目的
本多中心随机对照试验的主要目的是测试使用非沉浸式虚拟现实康复系统(即 VRRS HomeKit 设备)进行高级培训对 SABI 患者功能结果的有效性。
方法
共有 40 名 SABI 患者及其 40 名护理人员在意大利的 2 个康复中心参与了研究方案并被随机分为 2 组。40 名患者中,20 名(50%)接受了 VRRS HomeKit(远程神经-VRRS 组)的实验训练,而其他 20 名(50%)接受了常规区域康复治疗(UTRTs;对照组)。为了研究运动和神经心理学功能,SABI 患者在每次训练结束前(T0)和结束时(T1)由多专科团队通过全面的临床和心理计量学评估:巴氏指数(BI)、Tinetti 量表(TS)、改良 Ashworth 量表(MAS)、蒙特利尔认知评估(MoCa)、额叶评估量表(FAB)、贝克抑郁量表 II(BDI-II)、36 项简短健康调查(SF-36)和一般心理幸福感指数(PGWBI)。此外,对每位护理人员进行了照顾者负担量表(CBI)评估,以调查其情绪负担状况。
结果
与对照组相比,远程神经-VRRS 组在一般和运动结果以及心理幸福感和生活质量方面均取得了统计学上的显著改善。特别是 BI(P<.001)、FAB(P<.001)和 BDI-II(P<.001)是改善效果最好的量表。远程神经-VRRS 组的护理人员负担也显著改善(CBI;P<.004)。组间分析显示,PGWBI 的焦虑(效应量[ES]=0.85,P<.02)和自我控制(ES=0.40,P<.03)子测验以及 SF-36 的社会角色功能(ES=0.85,P<.02)子测验有统计学差异,这在相当大和中等的 ES 中得到了证实。
结论
我们的结果表明,VRRS 是一种合适的替代工具或补充工具,可改善 SABI 患者的运动(功能独立性水平)和认知(额叶/执行能力)结果,减少行为改变(焦虑和抑郁症状),对护理人员的负担也有有益的影响,减轻了护理人员的困扰,并促进了积极的护理方面。
试验注册
ClinicalTrials.gov NCT03709875; https://classic.clinicaltrials.gov/ct2/show/NCT03709875.