UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044056 |
|---|---|
| Receipt number | R000049740 |
| Scientific Title | Effect of high and low frequency neuromuscular electrical stimulation therapy for swallowing function |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2021/04/27 19:27:12 |
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Basic information
Public title
Effect of high and low frequency neuromuscular electrical stimulation therapy for swallowing function
Acronym
Effect of high and low frequency neuromuscular electrical stimulation therapy for swallowing function
Scientific Title
Effect of high and low frequency neuromuscular electrical stimulation therapy for swallowing function
Scientific Title:Acronym
Effect of high and low frequency neuromuscular electrical stimulation therapy for swallowing function
Region
| Japan |
Condition
Condition
healthy elderly
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarifie the effective intervention frequency of neuromuscular electrical stimulation therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Videofluorography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Three times interventions a week(4 weeks)
Interventions/Control_2
Weekly intervention(4 weeks)
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
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly people without dysphagia
Key exclusion criteria
artificial cardiac pacemaker user,dysphagia,cognitive function decline,tracheolytic openings,digestive tract,acute bleeding,blockage
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | maya |
| Middle name | |
| Last name | nakahira |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
7838505
Address
Kohasu, Okou, Nankoku, Kochi, Japan.
TEL
0888802490
jm-nakahira-m@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | maya |
| Middle name | |
| Last name | nakahira |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
7838505
Address
Kohasu, Okou, Nankoku, Kochi, Japan.
TEL
0888802490
Homepage URL
jm-nakahira-m@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Kochi Medical School
Address
Kohasu, Okou, Nankoku, Kochi, Japan.
Tel
088-880-2180
is21@kochi-u.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
| 2021 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2021 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049740
