UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040537 |
|---|---|
| Receipt number | R000042529 |
| Scientific Title | Construction of remote swallowing rehabilitation using web conference system |
| Date of disclosure of the study information | 2020/05/27 |
| Last modified on | 2023/05/30 17:14:55 |
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Basic information
Public title
Construction of remote swallowing rehabilitation using web conference system
Acronym
Construction of remote swallowing rehabilitation
Scientific Title
Construction of remote swallowing rehabilitation using web conference system
Scientific Title:Acronym
Construction of remote swallowing rehabilitation
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of "promoting intervention of self-training" on the continuation rate of self-training using Web conferencing system
To clarify whether the tongue muscle strength training under face-to-face / remote combined condition is as effective as face-to-face condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Persistence rate of self-training for patients with dysphagia
Changes in maximum tongue pressure before and after training
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To perform "self-training facilitative intervention" using Web conferencing system
Interventions/Control_2
Tongue muscle strength training is performed under two conditions: face-to-face condition and face-to-face / remote combination condition.
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inpatients or outpatients who are diagnosed dysphagia
Key exclusion criteria
Patients who can not communicate
Patients with tube feeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Fumitaka |
| Middle name | |
| Last name | Omori |
Organization
Fukuoka Dental College Hospital
Division name
Department of Otorhinolaryngology
Zip code
8140175
Address
2-15-1, Tamura, Sawara-ku, Fukuoka, Japan
TEL
0928010411
omori@college.fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Fumitaka |
| Middle name | |
| Last name | Omori |
Organization
Fukuoka Dental College Hospital
Division name
Department of Otorhinolaryngology
Zip code
8140175
Address
2-15-1, Tamura, Sawara-ku, Fukuoka, Japan
TEL
0928010411
Homepage URL
omori@college.fdcnet.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Fukuoka Dental College Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Dental College
Address
2-15-1, Tamura, Sawara-ku, Fukuoka, Japan
Tel
0928010411
shomu@college.fdcnet.ac.jp
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
| 2020 | Year | 05 | Month | 27 | 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
| Delay expected |
Results Delay Reason
Data collection has been delayed due to COVID 19.
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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042529
