UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031824 |
|---|---|
| Receipt number | 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 | 2021/06/09 09:39:56 |
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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
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
rehabmed@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036347
