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Clinical Trials/JPRN-jRCTs062200054
JPRN-jRCTs062200054
Recruiting
Phase 2

Study on the effectiveness of rehabilitation using Soft-PAP for oral hypofunction in patients with dysarthria and dysphagia - Study on the effectiveness of soft PAP

Kodama Naoki0 sites100 target enrollmentFebruary 16, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dysarthria, Dysphagia
Sponsor
Kodama Naoki
Enrollment
100
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 16, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kodama Naoki

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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