UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019478 |
|---|---|
| Receipt number | R000022194 |
| Scientific Title | The Study on Swallowing ability by INterferential current frequency Electrical Stimulation (SINE Stim Study) |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2018/07/17 15:29:56 |
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Basic information
Public title
The Study on Swallowing ability by INterferential current frequency Electrical Stimulation
(SINE Stim Study)
Acronym
Interferential current and swallowing (SINE Stim study)
Scientific Title
The Study on Swallowing ability by INterferential current frequency Electrical Stimulation
(SINE Stim Study)
Scientific Title:Acronym
Interferential current and swallowing (SINE Stim study)
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of neuro-muscular electrical stimulation with interferential current frequency in dysphagic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Silent aspiration assessed by cough test.
(One night and 7 days after intervention period)
Key secondary outcomes
Swallowing ability assessed by Functional Oral Intake Scale.
Amount of nutritional intake by mouth.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ICF (2000Hz, 2050Hz), 2-3mA, 15 min./session
2 sessions/day
5 days/week
2 weeks (total 20 sessions)
Interventions/Control_2
ICF (2000Hz, 2050Hz), 0.0mA, 15 min./session
2 sessions/day
5 days/week
2 weeks (total 20 sessions)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dyaphagic inpatients whom SLP gives dysphagia rehabilitation and who are expected to receive rehabilitation for 3 or more weeks.
Key exclusion criteria
Patients who do not consent to entry.
Patients who can not keep still during the stimulation.
Patients who don't provoke cough reflex with citric acid cough test.
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Maeda |
Organization
Tamana Regional Health Medical Center
Division name
Department of Nutrition and Dysphagia Rehabilitation
Zip code
Address
2172 Tamana, Tamana, Kumamoto, Japan
TEL
+81968725111
maeda4work@tng.bbiq.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Maeda |
Organization
Tamana Regional Health Medical Center
Division name
Department of Nutrition and Dysphagia Rehabilitation
Zip code
Address
2172 Tamana, Tamana, Kumamoto, Japan
TEL
+81968725111
Homepage URL
maeda4work@tng.bbiq.jp
Sponsor or person
Institute
Tamana Regional Health Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
玉名地域保健医療センター（熊本県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 07 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 23 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022194
