UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061593 |
|---|---|
| Receipt number | R000070473 |
| Scientific Title | Immediate impact of interferential current electrical stimulation in patients with dysphagia: a randomized crossover study |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/16 00:18:54 |
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Basic information
Public title
Immediate impact of interferential current electrical stimulation in patients with dysphagia
Acronym
Interferential current electrical stimulation in patients with dysphagia
Scientific Title
Immediate impact of interferential current electrical stimulation in patients with dysphagia: a randomized crossover study
Scientific Title:Acronym
Immediate impact of interferential current electrical stimulation in patients with dysphagia
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to investigate both immediate and sustained effects of interferential current electrical stimulation (IFCS) from multiple perspectives by assessing small- and large-volume water intakes, saliva swallowing, and cough test (reflecting laryngeal sensation).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cough frequency and latency time of cough test
repetitive saliva swallowing test
modified water swallowing test
100-mL water swallowing test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment |
Interventions/Control_1
Interferential current stimulation: Stimulation intensity was 3.0mA
Interventions/Control_2
Interferential current stimulation: Stimulation intensity was 0.1mA
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Disturbances of deglutition as reflected by an Eating Assessment Tool-10 (EAT-10) score >= 3 and a Functional Oral Intake Scale (FOIS) =< 6
Key exclusion criteria
1.dry mouth syndrome
2.head and neck cancer
3.severe cognitive impairment to the extent of being unable to comprehend instructions
4.asthma
5.epilepsy
6.use of a pacemaker
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Yoichiro |
| Middle name | |
| Last name | Aoyagi |
Organization
Nippon Medical School
Division name
Department of Rehabilitation Medicine, Graduate School of Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
yyy@rc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Aoyagi |
Organization
Nippon Medical School
Division name
Department of Rehabilitation Medicine, Graduate School of Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
Homepage URL
yyy@rc5.so-net.ne.jp
Sponsor or person
Institute
Akashi Rehabilitation Hospital
Institute
Department
Personal name
Eiji Shumeno
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
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
Akashi Rehabilitation Hospital
Address
685-3 Nishifutami, Futamicho, Akashi, Hyogo
Tel
+81-78-941-6161
Shumeno.eiji.st@gmail.com
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
| 2026 | Year | 05 | Month | 18 | 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
33
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
| 2023 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 16 | Day |
Last modified on
| 2026 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070473
