UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Study on Swallowing ability by INterferential current frequency Electrical Stimulation (SINE Stim Study)
Title of the study (Brief title)	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	Keisuke Maeda
Organization	Tamana Regional Health Medical Center
Division name	Department of Nutrition and Dysphagia Rehabilitation
Address	2172 Tamana, Tamana, Kumamoto, Japan
TEL	+81968725111
Email	maeda4work@tng.bbiq.jp

Public contact
Name of contact person	Keisuke Maeda
Organization	Tamana Regional Health Medical Center
Division name	Department of Nutrition and Dysphagia Rehabilitation
Address	2172 Tamana, Tamana, Kumamoto, Japan
TEL	+81968725111
Homepage URL
Email	maeda4work@tng.bbiq.jp

Sponsor
Institute	Tamana Regional Health Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022194