UMIN-CTR Clinical Trial

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 Eiichi Middle name Last name Saitoh
Organization	Fujita Health University
Division name	Department of Rehabilitation Medicine I, School of Medicine
Zip code	470-1192
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 Mao Middle name Last name Ogawa
Organization	Fujita Health University
Division name	Department of Rehabilitation Medicine I, School of Medicine
Zip code	470-1192
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	Fujita Health University
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
Tel	0562-93-2167
Email	rehabmed@fujita-hu.ac.jp

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
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	Completed
Date of protocol fixation	2018 Year 03 Month 19 Day
Date of IRB	2018 Year 03 Month 19 Day
Anticipated trial start date	2018 Year 03 Month 22 Day
Last follow-up date	2021 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	2018 Year 03 Month 21 Day
Last modified on	2021 Year 06 Month 09 Day

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