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一项基于信息技术的干预措施在失语症中风患者中支持言语和语言治疗的实施与效果:虚拟随机对照试验方案

Implementation and Effects of an Information Technology-Based Intervention to Support Speech and Language Therapy Among Stroke Patients With Aphasia: Protocol for a Virtual Randomized Controlled Trial.

作者信息

Kim Esther S, Laird Laura, Wilson Carlee, Bieg Till, Mildner Philip, Möller Sebastian, Schatz Raimund, Schwarz Stephanie, Spang Robert, Voigt-Antons Jan-Niklas, Rochon Elizabeth

机构信息

Department of Communication Sciences and Disorders, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, AB, Canada.

Department of Speech-Language Pathology, University of Toronto, Toronto, ON, Canada.

出版信息

JMIR Res Protoc. 2021 Jul 2;10(7):e30621. doi: 10.2196/30621.

Abstract

BACKGROUND

Mobile app-based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia as adjuncts or substitutes for traditional in-person therapy approaches. These apps can increase the intensity of treatment and have resulted in meaningful outcomes across several domains.

OBJECTIVE

VoiceAdapt is a mobile therapy app designed with user and stakeholder feedback within a user-centered design framework. VoiceAdapt uses two evidence-based lexical retrieval treatments to help people with aphasia in improving their naming abilities through interactions with the app. The purpose of the randomized controlled trial (RCT) proposed here is to examine the feasibility and clinical efficacy of training with VoiceAdapt on the language and communication outcomes of people with aphasia.

METHODS

A multicenter RCT is being conducted at two locations within Canada. A total of 80 people with aphasia will be recruited to participate in a two-arm, waitlist-controlled, crossover group RCT. After baseline assessment, participants will be randomized into an intervention group or a waitlist control group. The intervention group participants will engage in 5 weeks of training with the app, followed by posttreatment and follow-up assessments after an additional 5 weeks. Those in the waitlist control group will have no training for 5 weeks; this is followed by pretreatment assessment, training for 5 weeks, and posttreatment assessment. All trial procedures are being conducted remotely given the COVID-19 pandemic.

RESULTS

Recruitment of participants started in September 2020, and the study is expected to be completed by March 2022. Publication of results is expected within 6 months of study completion.

CONCLUSIONS

The results of the RCT will provide information on evidence-based practice using technology-based solutions to treat aphasia. If positive results are obtained from this RCT, the VoiceAdapt app can be recommended as an efficacious means of improving lexical retrieval and communicative functioning in people with aphasia in an easily accessible and a cost-effective manner. Moreover, the implementation of this RCT through remote assessment and delivery can provide information to therapists on telerehabilitation practices and monitoring of app-based home therapy programs.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04108364; https://clinicaltrials.gov/ct2/show/NCT04108364.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30621.

摘要

背景

基于移动应用程序的疗法越来越多地被言语病理学家用于失语症患者的康复治疗,作为传统面对面治疗方法的辅助手段或替代方法。这些应用程序可以提高治疗强度,并在多个领域产生了有意义的结果。

目的

VoiceAdapt是一款移动治疗应用程序,它是在以用户为中心的设计框架内,根据用户和利益相关者的反馈设计而成。VoiceAdapt采用两种基于证据的词汇检索疗法,通过与应用程序的交互帮助失语症患者提高命名能力。本文提出的随机对照试验(RCT)的目的是检验使用VoiceAdapt进行训练对失语症患者语言和沟通结果的可行性和临床疗效。

方法

在加拿大的两个地点进行一项多中心随机对照试验。总共将招募80名失语症患者参加一项双臂、等待列表对照、交叉组随机对照试验。在基线评估后,参与者将被随机分为干预组或等待列表对照组。干预组参与者将使用该应用程序进行5周的训练,随后在另外5周后进行治疗后评估和随访评估。等待列表对照组的参与者将有5周不进行训练;然后进行治疗前评估、5周训练和治疗后评估。鉴于COVID-19大流行,所有试验程序均通过远程方式进行。

结果

参与者招募于2020年9月开始,该研究预计于2022年3月完成。预计在研究完成后6个月内公布结果。

结论

随机对照试验的结果将提供有关使用基于技术的解决方案治疗失语症的循证实践的信息。如果该随机对照试验获得阳性结果,VoiceAdapt应用程序可以被推荐为一种以易于获取且具有成本效益的方式改善失语症患者词汇检索和沟通功能的有效手段。此外,通过远程评估和实施该随机对照试验,可以为治疗师提供有关远程康复实践和基于应用程序的家庭治疗计划监测的信息。

试验注册

ClinicalTrials.gov NCT04108364;https://clinicaltrials.gov/ct2/show/NCT04108364。

国际注册报告识别码(IRRID):DERR1-10.2196/30621。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95f3/8285741/6056f28cf2c6/resprot_v10i7e30621_fig1.jpg

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