Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial
Introduction 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 f...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e060040.full |
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| author | Naoki Kodama Tomonori Yokoyama Takao Mukai Kana Takao Takashi Hiraoka Nobuyuki Arai Jitsuro Yano Hiroaki Nagatsuka Yousuke Manda Kozo Hanayama Shogo Minagi |
| author_facet | Naoki Kodama Tomonori Yokoyama Takao Mukai Kana Takao Takashi Hiraoka Nobuyuki Arai Jitsuro Yano Hiroaki Nagatsuka Yousuke Manda Kozo Hanayama Shogo Minagi |
| author_sort | Naoki Kodama |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number jRCTs062200054. |
| format | Article |
| id | doaj-art-a9ec9eb3a92147cdbacbd3e2506863a1 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a9ec9eb3a92147cdbacbd3e2506863a12025-01-31T05:55:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-060040Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trialNaoki Kodama0Tomonori Yokoyama1Takao Mukai2Kana Takao3Takashi Hiraoka4Nobuyuki Arai5Jitsuro Yano6Hiroaki Nagatsuka7Yousuke Manda8Kozo Hanayama9Shogo Minagi10Division of Psychosomatic Medicine, Department of Neurology, University of Occupational and Environmental Health, Kitakyushu, JapanDepartment of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, JapanDivision of Oral Surgery, Kawasaki Medical School Hospital, Kurashiki, JapanDivision of Oral Surgery, Kawasaki Medical School Hospital, Kurashiki, JapanDepartment of Rehabilitation Medicine, Kawasaki Medical School, Kurashiki, JapanDepartment of Rehabilitation Medicine, Kawasaki Medical School, Kurashiki, JapanDepartment of Speech-Language Pathology and Audiology, Faculty of Rehabilitation, Kawasaki University of Medical Welfare, Kurashiki, JapanDepartment of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, JapanDepartment of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, JapanDepartment of Rehabilitation Medicine, Kawasaki Medical School, Kurashiki, JapanDepartment of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, JapanIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number jRCTs062200054.https://bmjopen.bmj.com/content/12/7/e060040.full |
| spellingShingle | Naoki Kodama Tomonori Yokoyama Takao Mukai Kana Takao Takashi Hiraoka Nobuyuki Arai Jitsuro Yano Hiroaki Nagatsuka Yousuke Manda Kozo Hanayama Shogo Minagi Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial BMJ Open |
| title | Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial |
| title_full | Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial |
| title_fullStr | Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial |
| title_full_unstemmed | Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial |
| title_short | Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial |
| title_sort | efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia a protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e060040.full |
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