UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.
Title of the study (Brief title)	Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.
Region	Japan

Condition
Condition	Patients with dysphagia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify of effectiveness using neuromuscular electrical stimulation for patients with dysphagia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Videofluorography
Key secondary outcomes	Videoendoscopy High-resolution manometry Surface electromyogram

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	swallowing rehabilitation only
Interventions/Control_2	Neuromuscular electrical stimulation Duration of a treatment session: 30 minutes Duration of the treatment: 5days/week for 2 weeks
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	Patients with pharyngeal dysphagia.
Key exclusion criteria	1) Severe higher cortical dysfunction 2) Dementia 3) Neuromuscular diseases 4) Patients with tracheotomy 5) Patients with a pacemaker
Target sample size	60

Research contact person
Name of lead principal investigator	Maya Nakahira
Organization	Kochi Medical School University
Division name	Rehabilitation Center
Address	Kohasu, Oko-cho, Nankoku City,Kochi, 783-8505 JAPAN
TEL	088-880-2490
Email	jm-nakahira-m@kochi-u.ac.jp

Public contact
Name of contact person	Maya Nakahira
Organization	Kochi Medical School University
Division name	Rehabilitation Center
Address	Kohasu, Oko-cho, Nankoku City,Kochi, 783-8505 JAPAN
TEL	088-880-2490
Homepage URL
Email	jm-nakahira-m@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School University
Institute
Department

Funding Source
Organization	Japan science and technology agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	高知大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 12 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 11 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032268