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Study on the effectiveness of soft PAP

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062200054
Enrollment
100
Registered
2021-02-16
Start date
2021-09-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysarthria, Dysphagia Dysarthria

Interventions

Insertion of soft PAP

Sponsors

Kodama Naoki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
PTT(Pharyngeal transit time) Single-word Intelligibility Test

Secondary

MeasureTime frame
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

Contacts

Public ContactShogo Minagi

Okayama University Hospital

minagi@md.okayama-u.ac.jp+81-86-235-6685

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026