Study on the effectiveness of soft PAP

Phase 2

Recruiting

• Conditions: Dysarthria, Dysphagia; Dysarthria; D004401

• Registration Number: JPRN-jRCTs062200054
• Lead Sponsor: Kodama Naoki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Less than 2 weeks after the beginning of speech/swallow rehabilitation in acute hospital
2) dysarthria patient with speech intelligibility higher than 2, or swallowing disorder patient with preparatory stage, oral stage or pharyngeal stage disorder
3) patients aged 20 years or older at the time of acquiring consent
4) patient with written agreement for participating this study after receiving full explanation on this study and understanding the meaning

Exclusion Criteria

1) patient with consciousness disorder with Japan Coma Scale of II or III
2) patient of upper edentulous and who can not wear soft PAP
3) patient with residual teeth of high mobility which causes difficulty in taking dental impression
4) patient who can not follow the instructions necessary for the evaluation of tongue function and speech function
5) patient whom principal Investigator considered inappropriate to participate this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PTT(Pharyngeal transit time)<br>Single-word Intelligibility Test

Secondary Outcome Measures

Name	Time	Method
tongue function (maximal tongue pressure, iteration count of tongue movement, maximal tongue pressing duration), speech function (speech intelligibility, Oral DDK, V-RQOL), EAT-10 score