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. 2022 Jul 14;12(7):e060040.
doi: 10.1136/bmjopen-2021-060040.

Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial

Tomonori Yokoyama  1   2 , Takao Mukai  3 , Naoki Kodama  4 , Kana Takao  3 , Takashi Hiraoka  5 , Nobuyuki Arai  5 , Jitsuro Yano  6 , Hiroaki Nagatsuka  1   7 , Yousuke Manda  1 , Kozo Hanayama  5 , Shogo Minagi  1
Affiliations

Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial

Tomonori Yokoyama et al. BMJ Open. .

Abstract

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.

Keywords: geriatric medicine; oral medicine; rehabilitation medicine.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Soft palatal augmentation prosthesis.
Figure 2
Figure 2
Study flow chart. PAP, palatal augmentation prosthesis.
Figure 3
Figure 3
Soft palatal augmentation prosthesis (soft PAP) used in the SP group: type 1 and type 2.
Figure 4
Figure 4
Outcome measures and time points. PAP, palatal augmentation prosthesis.
Figure 5
Figure 5
The tongue pressure measurement device (TPM-01, JMS, Hiroshima) is connected to a personal computer. Measurements are performed with real-time visual feedback on the screen.
Figure 6
Figure 6
An example of measurements obtained when 50% of Pmax is considered the target tongue pressure.
Figure 7
Figure 7
Measurement of the endurance of tongue pressure (ETP): A, B and C show a schematic sample of the endpoint of ETP. A: Tongue pressure decreased between 40% and 50% of Pmax for 2 s with subsequent pressure recovery to >50% of Pmax. B: Tongue pressure decreased below 40% of Pmax for 0.5 s with subsequent pressure recovery to >50 of % Pmax. C: Tongue pressure decreased below 50% of Pmax without any subsequent recovery to >50% of Pmax.
See this image and copyright information in PMC

References

    1. Practice Guidelines for palatal augmentation prosthesis (PAP) for Dysphagia and Dysarthria in Japan 2020. Available: https://hotetsu.com/files/files_536.pdf
    1. Ueda K, Mukai Y, Morita M. The effectiveness of palatal augmentation prosthesis for dysphagia. Jap J Dysphag Rehabil 2012;16:32–41.
    1. Bernhardt J, Dewey H, Thrift A, et al. . A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility. Stroke 2008;39:390–6. 10.1161/STROKEAHA.107.492363 - DOI - PubMed
    1. Marunick M, Tselios N. The efficacy of palatal augmentation prostheses for speech and swallowing in patients undergoing glossectomy: a review of the literature. J Prosthet Dent 2004;91:67–74. 10.1016/j.prosdent.2003.10.012 - DOI - PubMed
    1. Wheeler RL, Logemann JA, Rosen MS. Maxillary reshaping prostheses: effectiveness in improving speech and swallowing of postsurgical oral cancer patients. J Prosthet Dent 1980;43:313–9. 10.1016/0022-3913(80)90408-4 - DOI - PubMed

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