增强和替代沟通干预对卒中后失语症住院患者的影响：一项平行组、实用随机对照试验的研究方案。

Augmentative and alternative communication intervention for in-patient individuals with post-stroke aphasia: study protocol of a parallel-group, pragmatic randomized controlled trial.

机构信息

Department of Rehabilitation Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110 Ganhe Road, Hongkou District, Shanghai, 200437, China.

Department of Communication Sciences and Disorders , University of New Hampshire, 4 Library Way, Hewitt Hall, Room 144, Durham, NH, USA, 03824.

出版信息

Trials. 2021 Nov 24;22(1):837. doi: 10.1186/s13063-021-05799-0.

DOI:10.1186/s13063-021-05799-0

PMID:34819130

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8611624/

Abstract

BACKGROUND

People with post-stroke aphasia commonly receive speech-language therapy (SLT) when they are admitted to hospitals. Commonly, these patients reported communication difficulties in in-patient settings. Augmentative and alternative communication (AAC) has been reported as an effective treatment approach to improve communication effectiveness, language performance, decreasing depression, and improving quality of life for this population. However, little evidence has demonstrated the use of AAC intervention (AACT) in early recovery from people with post-stroke aphasia in in-patient rehabilitation settings for improving these patients' communication effectiveness. The pilot randomized controlled trial (RCT) will explore the effectiveness and feasibility of including AACT in regular SLT for in-patient people with post-stroke aphasia.

METHOD

This pilot RCT is a single-blind, randomized controlled trial with two parallel groups. Both groups receive a 1-h treatment session, including either both AACT and SLT or SLT only for ten consecutive days. We aim to include 22 in-patient participants with post-stroke aphasia in each group. Participants will be assessed at pre- and post-intervention and 2 weeks after intervention. The primary outcomes are the ability of communication measured by the communication of basic needs subtest in the Functional Assessment of Communication Skills for Adult (FACS) and the overall language performance measured by the Chinese Standard Aphasia Battery (ABC). The secondary outcomes include a 10-min conversation, the 10-item Hospital version of the Stroke Aphasic Depression Questionnaire (SADQH-10), the Stroke-Specific Quality of Life Scale (SS-QOL), and a patient and caregiver satisfaction questionnaire.

DISCUSSION

This pilot RCT will contribute to new scientific evidence to the field of aphasia rehabilitation in early recovery during the in-patient period. The paper describes the trial, which will explore the effect of combining AACT and SLT and SLT only, our choice of primary and secondary outcome measures, and proposed analyses. The study results will provide information for implementing AACT in the regular in-patient SLT of future RCTs.

TRIAL REGISTRATION

Chinese Clinical Trial Registry database (ChiCTR) ChiCTR2000028870 . Registered on 5 January 2020.

摘要

背景

患有卒中后失语症的人在住院时通常会接受言语语言治疗（SLT）。通常，这些患者在住院环境中会报告沟通困难。增龄和替代沟通（AAC）已被报道为一种有效治疗方法，可提高沟通效率、语言表现、降低抑郁程度，并提高该人群的生活质量。然而，几乎没有证据表明在住院康复环境中，将 AAC 干预（AACT）用于早期卒中后失语症患者可提高这些患者的沟通效率。这项试点随机对照试验（RCT）将探讨在常规 SLT 中纳入 AACT 对住院卒中后失语症患者的有效性和可行性。

方法

这是一项单盲、随机对照试验，采用两平行组设计。两组均接受 1 小时的治疗，连续 10 天接受 AACT 和 SLT 联合治疗或仅接受 SLT 治疗。我们计划在每组中纳入 22 名住院的卒中后失语症患者。参与者将在干预前、干预后和干预后 2 周进行评估。主要结局是使用成人沟通功能评估（FACS）中的基本需求沟通测验和中国标准失语症测验（ABC）中的整体语言表现来衡量的沟通能力。次要结局包括 10 分钟的对话、医院版卒中后失语症抑郁问卷（SADQH-10）的 10 项、卒中特异性生活质量量表（SS-QOL）和患者和护理人员满意度问卷。