Department of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Division of Speech-Language-Hearing Therapy, Rehabilitation Center, Kawasaki Medical School Hospital, Kurashiki, Japan.
BMJ Open. 2022 Jul 14;12(7):e060040. doi: 10.1136/bmjopen-2021-060040.
Palatal augmentation prosthesis (PAP) is used in patients with articulation and swallowing disorders caused by postoperative loss of tongue tissue due to tongue cancer, cerebrovascular disease sequelae and age-related hypofunction. We have previously reported a newly designed soft PAP fabricated using an thermoplastic material that is particularly appropriate for early intervention. However, the effect of soft PAP on oral function improvement remains to be elucidated. The aim of this study is to investigate whether soft PAP can improve dysarthria and dysphagia occurring as cerebrovascular disease sequelae.
This prospective, randomised, controlled trial will compare the immediate and training effects of rehabilitation using soft PAP with those of rehabilitation without using it. Primary outcomes are the single-word intelligibility test score and pharyngeal transit time (PTT). Secondary outcomes are tongue function (evaluated based on maximum tongue pressure, repetitions of tongue pressure and endurance of tongue pressure), articulation function (evaluated based on speech intelligibility, oral diadochokinesis, Voice-Related Quality of Life (V-RQOL)) and swallowing function (evaluated using Eating Assessment Tool-10). The study results will help determine the efficacy of Soft PAP in improving functional outcomes of word intelligibility and PTT. We hypothesised that early rehabilitation using Soft PAP would more effectively improve articulation and swallowing function compared with conventional rehabilitation without using soft PAP.
Ethical approval was obtained from the Okayama University Certified Review Board. The study findings will be published in an open access, peer-reviewed journal and presented at relevant conferences and research meetings.
jRCTs062200054.
腭部增宽假体（PAP）用于因舌癌、脑血管病后遗症和年龄相关功能减退导致术后舌组织丧失而引起发音和吞咽障碍的患者。我们之前报道了一种使用热塑性材料制成的新型软 PAP，特别适合早期干预。然而，软 PAP 对改善口腔功能的效果仍有待阐明。本研究旨在探讨软 PAP 是否能改善因脑血管病后遗症引起的构音障碍和吞咽困难。
这是一项前瞻性、随机、对照试验，将比较使用软 PAP 进行康复治疗与不使用软 PAP 进行康复治疗的即时和训练效果。主要结局是单字清晰度测试评分和咽通过时间（PTT）。次要结局是舌功能（基于最大舌压、舌压重复次数和舌压耐力评估）、发音功能（基于语音清晰度、口腔交替运动、嗓音相关生活质量（V-RQOL）评估）和吞咽功能（使用进食评估工具-10 评估）。研究结果将有助于确定软 PAP 改善单词清晰度和 PTT 功能结局的疗效。我们假设早期使用软 PAP 进行康复治疗比不使用软 PAP 的常规康复治疗更有效地改善发音和吞咽功能。
伦理批准已获得冈山大学认证审查委员会批准。研究结果将在开放获取、同行评议的期刊上发表，并在相关会议和研究会议上展示。
jRCTs062200054。
