IRCCS Stella Maris Foundation, Pisa, Italy.
Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
BMC Neurol. 2022 Jul 6;22(1):246. doi: 10.1186/s12883-022-02771-6.
Children with cerebral palsy (CP) often have communication impairments, including speech altered intelligibility. Multiple levels of disrupted speech have been reported in CP, which negatively impact on participation and quality of life, with increase of care needs. Augmentative Alternative Communication (AAC) is an option, with debated benefits and limitations, in particular for its functional use. This is supported by a substantial lack of defined evidences in favor of direct speech articulation intervention in CP. Motor learning-based interventions are effective in CP and are the basis of speech motor interventions such as PROMPT (Prompts for Restructuring Oral Muscular Phonetic Targets). The PROMPT speech motor treatment provides tactile-kinesthetic inputs to facilitate articulatory movements by dynamic modelling, resulting in more efficient motor patterns that can be integrated into speech and communication. In CP, exploratory evidences support the feasibility and preliminarily advantages on intelligibility of motor speech treatments, such as PROMPT, with increased speech motor control, also documented by kinematic analyses.
A randomized waitlist-control trial will be conducted in children aged between 3- and 10-years having CP and dysarthria (estimated sample size = 60 children). Children will be allocated in the immediate intervention or in the waitlist control group. The intervention consists of an intensive 3 weeks period of twice-a-day administration of PROMPT. Standard care will be administered in the control (waitlist) group. After repeated baseline assessments (T0), the PROMPT treated group will undergo the experimental 3-week intervention period, with T1 assessment at the end. A further T2 assessment will be provided at medium term (3 months after the end of the intervention) for evaluating the stability of intervention. Primary and secondary speech clinical and kinematics outcome measures will be collected at T0, T1 and T2.
This paper describes the study protocol consisting of a RCT with two main objectives: (1) to evaluate the or short-term benefits of an intensive speech motor intervention on speech and intelligibility in children with CP and the stability of the intervention at medium term; (2) to describe the kinematic correlates of speech motor control modifications.
Trial registration date 06/12/2019; ClinicalTrials.gov Identifier: NCT04189159 .
脑瘫儿童(CP)常伴有沟通障碍,包括言语清晰度受损。CP 患者存在多个层面的言语障碍,这对其参与度和生活质量产生负面影响,导致其需要更多的护理。辅助沟通是一种选择,其具有一定的争议性,特别是在功能使用方面。这是因为目前缺乏支持 CP 患者直接言语发音干预的明确证据。基于运动学习的干预措施在 CP 中是有效的,并且是言语运动干预的基础,如 PROMPT(用于重构口腔肌肉发音目标的提示)。PROMPT 言语运动治疗通过动态建模提供触觉 - 运动输入,以促进发音运动,从而产生更有效的运动模式,这些模式可以整合到言语和交流中。在 CP 中,探索性证据支持运动言语治疗的可行性和初步优势,例如 PROMPT,其可以提高言语运动控制能力,这也可以通过运动分析来证明。
将对年龄在 3 至 10 岁之间患有脑瘫和构音障碍的儿童进行一项随机、等待期对照试验(预计样本量为 60 名儿童)。将儿童随机分配到即刻干预组或等待期对照组。干预措施包括密集的 3 周内每天两次 PROMPT 治疗。对照组(等待期)将接受标准护理。在基线重复评估(T0)后,PROMPT 治疗组将进行为期 3 周的实验干预,在结束时进行 T1 评估。在中期(干预结束后 3 个月)将进行 T2 评估,以评估干预的稳定性。将在 T0、T1 和 T2 时收集主要和次要的言语临床和运动学评估结果。
本文描述了一项 RCT 的研究方案,该 RCT 有两个主要目标:(1)评估强化言语运动干预对 CP 儿童言语和清晰度的短期益处,以及中期的干预稳定性;(2)描述言语运动控制改变的运动学相关性。
试验注册日期为 2019 年 12 月 6 日;临床试验.gov 标识符:NCT04189159。