UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060229 |
|---|---|
| Receipt number | R000068888 |
| Scientific Title | Effects of Swallowing Rehabilitation Using an Interferential Current-Type Low-Frequency Electrical Stimulation Device |
| Date of disclosure of the study information | 2026/01/17 |
| Last modified on | 2025/12/29 11:05:27 |
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Basic information
Public title
Effects of Swallowing Rehabilitation Using an Interferential Current-Type Low-Frequency Electrical Stimulation Device
Acronym
Effects of Swallowing Rehabilitation Using an Interferential Current-Type Low-Frequency Electrical Stimulation Device
Scientific Title
Effects of Swallowing Rehabilitation Using an Interferential Current-Type Low-Frequency Electrical Stimulation Device
Scientific Title:Acronym
Effects of Swallowing Rehabilitation Using an Interferential Current-Type Low-Frequency Electrical Stimulation Device
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Medicine in general | Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of electrical stimulation intervention using an interferential current-type low-frequency therapy device (GentleStim EX) on
Swallowing-related muscle strength (neck muscle strength, maximum tongue pressure)
Swallowing function (FILS, FOIS)
in adult patients with dysphagia, compared to conventional swallowing rehabilitation methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neck muscle strength
Maximum tongue pressure
Key secondary outcomes
FILS (Functional Intake Level Scale)
FOIS (Functional Oral Intake Scale)
Intervention continuity and presence of discomfort
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Electrical Stimulation Using the GentleStim EX (FGM01) Interference Current Type Low-Frequency Therapy Device
In addition to the above
Conventional Swallowing Rehabilitation (Head Elevation Training, Neck Resistance Exercise Training, Tongue Resistance Exercise Training, Respiratory Muscle Training, etc.)
Interventions/Control_2
Only conventional swallowing rehabilitation is performed. Conventional methods of dysphagia 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults with dysphagia at Numata Neurosurgery and Cardiology Hospital
Individuals receiving dysphagia rehabilitation
Individuals who received a thorough explanation of the research content and provided written consent
Key exclusion criteria
Implantable electronic medical device (pacemaker, etc.) wearers
Pregnant women and new mothers
Individuals with poor skin condition on the neck
Individuals who meet the contraindications listed in the device package insert
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | TETSURO |
| Middle name | |
| Last name | SAKAI |
Organization
Gunma Paz University
Division name
Faculty of Rehabilitation Department of Speech-Language-Hearing Sciences
Zip code
3700006
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
TEL
0272127046
t-sakai@paz.ac.jp
Public contact
Name of contact person
| 1st name | TETSURO |
| Middle name | |
| Last name | SAKAI |
Organization
Gunma Paz University
Division name
Faculty of Rehabilitation Department of Speech-Language-Hearing Sciences
Zip code
3700006
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
TEL
0272127046
Homepage URL
t-sakai@paz.ac.jp
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
Tel
0273653366
t-sakai@paz.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
群馬パース大学
沼田脳神経外科循環器科病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 17 | 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
| 2025 | Year | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068888
