面向康复的虚拟现实设备对缺血性卒中早期亚急性恢复期患者的影响:一项III期、单盲、随机、对照临床试验的研究方案

IF 2.6 Q2 CLINICAL NEUROLOGY Journal of Central Nervous System Disease Pub Date : 2020-01-21 eCollection Date: 2020-01-01 DOI:10.1177/1179573519899471
Nima Ahmed, Vitor A Queiroz Mauad, Olga Gomez-Rojas, Ammu Sushea, Gelanys Castro-Tejada, Janet Michel, Juan Manuel Liñares, Loise Pedrosa Salles, Ludmilla Candido Santos, Ming Shan, Rami Nassir, Raul Montañez-Valverde, Ronaldo Fabiano, Sofia Danyi, Seyed Hassan Hosseyni, Seerat Anand, Usman Ahmad, William Augusto Casteleins, Alma Tamara Sanchez, Ahmed Fouad, Alvaro Jacome, Mariana Sanali Moura de Oliveira Paiva, Ana Gabriela Saavedra Ruiz, Rubens A Grochowski, Mayumi Toyama, Hibatalla Nagi, Marcella Zanini Sarvodelli, Alexandra Halalau
{"title":"面向康复的虚拟现实设备对缺血性卒中早期亚急性恢复期患者的影响:一项III期、单盲、随机、对照临床试验的研究方案","authors":"Nima Ahmed, Vitor A Queiroz Mauad, Olga Gomez-Rojas, Ammu Sushea, Gelanys Castro-Tejada, Janet Michel, Juan Manuel Liñares, Loise Pedrosa Salles, Ludmilla Candido Santos, Ming Shan, Rami Nassir, Raul Montañez-Valverde, Ronaldo Fabiano, Sofia Danyi, Seyed Hassan Hosseyni, Seerat Anand, Usman Ahmad, William Augusto Casteleins, Alma Tamara Sanchez, Ahmed Fouad, Alvaro Jacome, Mariana Sanali Moura de Oliveira Paiva, Ana Gabriela Saavedra Ruiz, Rubens A Grochowski, Mayumi Toyama, Hibatalla Nagi, Marcella Zanini Sarvodelli, Alexandra Halalau","doi":"10.1177/1179573519899471","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and rationale: </strong>Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase.</p><p><strong>Method: </strong>This is a randomized, controlled trial that will assign 262 patients to tailor-made standard rehabilitation (TMSR) or TMSR plus immersive VR device. The trial will be conducted in an urban rehabilitation clinic in the United States with expertise in the management of poststroke patients. Patients will be 18 to 70 years of age and in the early subacute period (30-90 days post ischemic stroke). The primary outcome will be the change of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score, measured at baseline and 13 weeks after randomization. The secondary outcome will be the change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score at the same time points.</p><p><strong>Discussion: </strong>If the use of VR in the rehabilitation of patients with stroke proves to have a significant impact on their motor recovery, it will constitute an extremely important step into decreasing the functional impairment associated with stroke and the related health care expense burden.</p>","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":"12 ","pages":"1179573519899471"},"PeriodicalIF":2.6000,"publicationDate":"2020-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1179573519899471","citationCount":"6","resultStr":"{\"title\":\"The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.\",\"authors\":\"Nima Ahmed, Vitor A Queiroz Mauad, Olga Gomez-Rojas, Ammu Sushea, Gelanys Castro-Tejada, Janet Michel, Juan Manuel Liñares, Loise Pedrosa Salles, Ludmilla Candido Santos, Ming Shan, Rami Nassir, Raul Montañez-Valverde, Ronaldo Fabiano, Sofia Danyi, Seyed Hassan Hosseyni, Seerat Anand, Usman Ahmad, William Augusto Casteleins, Alma Tamara Sanchez, Ahmed Fouad, Alvaro Jacome, Mariana Sanali Moura de Oliveira Paiva, Ana Gabriela Saavedra Ruiz, Rubens A Grochowski, Mayumi Toyama, Hibatalla Nagi, Marcella Zanini Sarvodelli, Alexandra Halalau\",\"doi\":\"10.1177/1179573519899471\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and rationale: </strong>Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase.</p><p><strong>Method: </strong>This is a randomized, controlled trial that will assign 262 patients to tailor-made standard rehabilitation (TMSR) or TMSR plus immersive VR device. The trial will be conducted in an urban rehabilitation clinic in the United States with expertise in the management of poststroke patients. Patients will be 18 to 70 years of age and in the early subacute period (30-90 days post ischemic stroke). The primary outcome will be the change of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score, measured at baseline and 13 weeks after randomization. The secondary outcome will be the change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score at the same time points.</p><p><strong>Discussion: </strong>If the use of VR in the rehabilitation of patients with stroke proves to have a significant impact on their motor recovery, it will constitute an extremely important step into decreasing the functional impairment associated with stroke and the related health care expense burden.</p>\",\"PeriodicalId\":15218,\"journal\":{\"name\":\"Journal of Central Nervous System Disease\",\"volume\":\"12 \",\"pages\":\"1179573519899471\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2020-01-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1177/1179573519899471\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Central Nervous System Disease\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/1179573519899471\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2020/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Central Nervous System Disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/1179573519899471","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 6

摘要

背景和理由:中风被认为是成人残疾的最常见原因。强化康复方案优于非强化康复方案。亚急性中风期是恢复的潜在窗口期。虚拟现实(VR)已被证明提供了一个更刺激的环境,允许增加患者的依从性。然而,目前比较VR与标准疗法的文献质量有限。我们的目的是衡量VR与标准治疗对早期亚急性恢复期中风患者上肢运动功能恢复的影响。方法:这是一项随机对照试验,将262名患者分配到量身定制的标准康复(TMSR)或TMSR加沉浸式VR设备。该试验将在美国的一家城市康复诊所进行,该诊所具有中风后患者管理方面的专业知识。患者年龄为18 ~ 70岁,处于早期亚急性期(缺血性卒中后30 ~ 90天)。主要结果将是Fugl-Meyer评估-上肢(FMA-UE)评分的变化,在基线和随机化后13周测量。次要结果将是在同一时间点英国功能独立测量和功能评估测量(UK FIM-FAM)评分的变化。讨论:如果在脑卒中患者康复中使用VR被证明对其运动恢复有显著影响,这将是减少脑卒中相关功能障碍和相关医疗费用负担的极其重要的一步。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

摘要图片

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.

Background and rationale: Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase.

Method: This is a randomized, controlled trial that will assign 262 patients to tailor-made standard rehabilitation (TMSR) or TMSR plus immersive VR device. The trial will be conducted in an urban rehabilitation clinic in the United States with expertise in the management of poststroke patients. Patients will be 18 to 70 years of age and in the early subacute period (30-90 days post ischemic stroke). The primary outcome will be the change of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score, measured at baseline and 13 weeks after randomization. The secondary outcome will be the change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score at the same time points.

Discussion: If the use of VR in the rehabilitation of patients with stroke proves to have a significant impact on their motor recovery, it will constitute an extremely important step into decreasing the functional impairment associated with stroke and the related health care expense burden.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
6.90
自引率
0.00%
发文量
39
审稿时长
8 weeks
期刊最新文献
Association of high-sensitivity cardiac troponin T with territorial middle cerebral artery brain infarctions and dynamic cerebral autoregulation. Enriched environment may improve secondary brain injury after traumatic brain injury by regulating the TLR2/NF-κB signaling pathway. Letter re: Aseptic pleocytosis can only be classified as a phenotypic manifestation of MNGIE after exclusion of all differential causes. Decompressive craniectomy versus craniotomy for acute subdural hematoma: A systematic review and meta-analysis with an adjusted subgroup analysis. Hemorrhagic stroke in children.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1