UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028189
Receipt number R000032268
Scientific Title Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.
Date of disclosure of the study information 2017/07/12
Last modified on 2017/07/11 21:24:23

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Basic information

Public title

Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.

Acronym

Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.

Scientific Title

Effectiveness of neuromuscular electrical stimulation therapy combined with traditional dysphagia therapy for patients with dysphagia.

Scientific Title:Acronym

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

1st name
Middle name
Last name Maya Nakahira

Organization

Kochi Medical School University

Division name

Rehabilitation Center

Zip code


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

1st name
Middle name
Last name Maya Nakahira

Organization

Kochi Medical School University

Division name

Rehabilitation Center

Zip code


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 or person

Institute

Kochi Medical School University

Institute

Department

Personal name



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)



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

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


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

Preinitiation

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032268


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name