UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028655 |
|---|---|
| Receipt number | R000032507 |
| Scientific Title | A Study on the Effectiveness of Soft PAP for Dysarthria and Dysphagia |
| Date of disclosure of the study information | 2017/09/19 |
| Last modified on | 2019/08/20 10:27:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Effectiveness of Soft PAP for Dysarthria and Dysphagia
Acronym
Study on the effectiveness of soft PAP
Scientific Title
A Study on the Effectiveness of Soft PAP for Dysarthria and Dysphagia
Scientific Title:Acronym
Study on the effectiveness of soft PAP
Region
| Japan |
Condition
Condition
Disorder of tongue movement
Classification by specialty
| Neurology | Oto-rhino-laryngology | Oral surgery |
| Neurosurgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to examine the effectiveness of soft PAP used for dysarthria and eating dysphagia with impaired tongue movement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Verify the immediate effect of soft PAP. Compare the tongue movement function, articulation function, swallowing function between wearing and non-wearing conditions.
Key secondary outcomes
Verify the training effect every week through the hospitalization period. We evaluate the tongue motion function, articulation function and swallowing function when soft PAP is not attached.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group
Soft PAP is made, evaluate the articulation function and the swallowing function under the condition of wearing and not wearing, and verify the immediate effect. Also, evaluate when not wearing soft PAP every week through the hospitalization period and examine the training effect of soft PAP
Interventions/Control_2
Control group
Soft PAP is not produced. Evaluation is performed for the same period as in the intervention group, and treatment is performed with conventional rehabilitation.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Dysarthria and Dysphagia with movement disorder of the tongue
2) Patients aged 20 years or older at the time of acquiring consent
Key exclusion criteria
1) Patient with consciousness disorder
2) Patients who can not wear soft PAP
3) When implementing the evaluation content, patients who can not understand
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1,Shikata-cho, kita-ku, Okayama
TEL
086-235-6685
minagi@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1,Shikata-cho, kita-ku, Okayama
TEL
086-235-6685
Homepage URL
minagi@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032507
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
