UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023473
Receipt No. R000027046
Scientific Title The effect of neuromuscular electrical stimulation for dysphagia: A before-and after study
Date of disclosure of the study information 2016/08/04
Last modified on 2016/08/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of neuromuscular electrical stimulation for dysphagia: A before-and after study
Acronym The NMES for dysphagia
Scientific Title The effect of neuromuscular electrical stimulation for dysphagia: A before-and after study
Scientific Title:Acronym The NMES for dysphagia
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of neuromuscular electrical stimulation (NMES) for healthy subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Video analysis of swallowing function
Key secondary outcomes fNIRS, questionnnaire, blood pressure, heart rate, SpO2, adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Neuromuscular electrical stimulation
Interventions/Control_2
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 1) normal swallowing function
2) age is over 20 years
Key exclusion criteria 1) history of neurological disease
2) severe arrhythmia or pacemaker implantation
3) severe higher cortical dysfunction, dementia, loss of consciousness
4) severe sensory disturbance or skin disease
5) patients who disagree to participate in this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Email shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Homepage URL
Email shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization N/A
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 04 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
Date of protocol fixation
2016 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2016 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027046

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.