UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031824
Receipt No. R000036347
Scientific Title Effect of repetitive peripheral magnetic stimulation for suprahyoid muscles - A randomized controlled trial in healthy individuals -
Date of disclosure of the study information 2018/03/21
Last modified on 2019/01/06

* 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 Effect of repetitive peripheral magnetic stimulation for suprahyoid muscles - A randomized controlled trial in healthy individuals -
Acronym A randomized controlled trial for suprahyoid muscles by peripheral magnetic stimulation
Scientific Title Effect of repetitive peripheral magnetic stimulation for suprahyoid muscles - A randomized controlled trial in healthy individuals -
Scientific Title:Acronym A randomized controlled trial for suprahyoid muscles by peripheral magnetic stimulation
Region
Japan

Condition
Condition healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of peripheral magnetic stimulation for suprahyoid muscles with head raising exercise
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the strength of suprahyoid muscles after 2 weeks exercise
Key secondary outcomes Changes in muscle fatigue, tongue strength, hyoid movement and pressure of upper esophageal sphincter after 2 weeks exercise

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Two weeks peripheral magnetic stimulation: 10 minutes stimulation for 3 times per day, 5 days per week
Interventions/Control_2 Two weeks head raising exercise: Three repetitive 1-min sustained head raisings in the supine position, interrupted by a 1-min rest period followed by 30 consecutive repetitions of head raisings for 3 times per day, 5 days per week
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

Not applicable
Gender Male and Female
Key inclusion criteria Individuals aged 20 years or older who had no history of stroke or neuromuscular, pharynx, larynx, upper gastrointestinal, and pulmonary diseases who gave informed consent were recruited
Key exclusion criteria Individuals who used cardiac pacemaker, had magnetic materials near the suprahyoid muscles, had difficulty in head raising due to neck diseases, a history of epilepsy, pregnant women, and showed less than 5.3mm hyoid forward displacement during magnetic stimulation were excluded.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Saitoh
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mao Ogawa
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Homepage URL
Email rehabmed@fujita-hu.ac.jp

Sponsor
Institute Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

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
2018 Year 03 Month 21 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 22 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
2018 Year 03 Month 21 Day
Last modified on
2019 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.