UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023473 |
|---|---|
| Receipt number | R000027046 |
| Scientific Title | The effect of neuromuscular electrical stimulation for dysphagia: A before-and after study |
| Date of disclosure of the study information | 2016/08/04 |
| Last modified on | 2016/08/04 10:54:59 |
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Basic information
Public title
The effect of neuromuscular electrical stimulation for dysphagia: A before-and after study
Acronym
The NMES for dysphagia
Scientific Title
The effect of neuromuscular electrical stimulation for dysphagia: A before-and after study
Scientific Title:Acronym
The NMES for dysphagia
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of neuromuscular electrical stimulation (NMES) for healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Video analysis of swallowing function
Key secondary outcomes
fNIRS, questionnnaire, blood pressure, heart rate, SpO2, adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Neuromuscular electrical stimulation
Interventions/Control_2
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) normal swallowing function
2) age is over 20 years
Key exclusion criteria
1) history of neurological disease
2) severe arrhythmia or pacemaker implantation
3) severe higher cortical dysfunction, dementia, loss of consciousness
4) severe sensory disturbance or skin disease
5) patients who disagree to participate in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
shushu@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
Homepage URL
shushu@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
| 2016 | Year | 08 | Month | 04 | 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
Date of protocol fixation
| 2016 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 04 | 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
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2016 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027046
