UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the efficacy of swallowing rehabilitation between that with interferential current stimulation and that with VitalStim therapy
Acronym	Efficacy of interferential current stimulation and VitalStim therapy
Scientific Title	Comparison of the efficacy of swallowing rehabilitation between that with interferential current stimulation and that with VitalStim therapy
Scientific Title:Acronym	Efficacy of interferential current stimulation and VitalStim therapy
Region	Japan

Condition
Condition	patients with dysphagia
Classification by specialty	Neurology Geriatrics Oto-rhino-laryngology Oral surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the efficacy of swallowing rehabilitation for stable patients with dysphagia between that with interferential current stimulation and that with VitalStim therapy over that without additional therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Swallowing function assessment by videofluorography
Key secondary outcomes	Mann Assessment of Swallowing Ability (MASA), Simple two step swallowing provocation test, tongue pressure, Manual Muscle Testing (MMT) of quadriceps femoris

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	swallowing rehabilitation only
Interventions/Control_2	swallowing rehabilitation with interferential current stimulation
Interventions/Control_3	swallowing rehabilitation with VitalStim therapy
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	Patients in recovery beds with dysphagia within three months after the onset of disease, who are treated with swallowing rehabilitation
Key exclusion criteria	1. Respiratory, chest wall, and mediastinal disturbances due to aspiration greater than grade 2 (Common Terminology Criteria for Adverse Events (CTCAE) v4.0) 2. Severe dementia (MMSE < 10) 3. Those who cannot report sensations associated with electrical stimulation 4. Those who are judged by a medical stuff in charge as inappropriate candidates
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshitaka Oku
Organization	Hyogo College of Medicine
Division name	Division of Physiome, Department of Medicine
Zip code
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL	0798-45-6385
Email	yoku@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshitaka Oku
Organization	Hyogo College of Medicine
Division name	Division of Physiome, Department of Medicine
Zip code
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL	0798-45-6385
Homepage URL
Email	kobayuu1@hyo-med.ac.jp

Sponsor
Institute	Kyoto University Hospital Clinical Research Center for Medical Equipment Development
Institute
Department

Funding Source
Organization	J Craft Co.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	わかくさ竜間リハビリテーション病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 15 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	Terminated
Date of protocol fixation	2013 Year 12 Month 27 Day
Date of IRB	2014 Year 05 Month 15 Day
Anticipated trial start date	2014 Year 05 Month 15 Day
Last follow-up date	2018 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	2014 Year 04 Month 16 Day
Last modified on	2019 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016029