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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028655
Receipt No. 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 2018/08/17

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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
Email 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
Email minagi@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
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
2018 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.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


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