UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016997 |
|---|---|
| Receipt number | R000019721 |
| Scientific Title | Effect of power-assisted electrical stimulation for suprahyoid muscles in healthy subjects |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2018/06/03 16:38:25 |
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Basic information
Public title
Effect of power-assisted electrical stimulation for suprahyoid muscles in healthy subjects
Acronym
Power-assisted electrical stimulation for suprahyoid muscles
Scientific Title
Effect of power-assisted electrical stimulation for suprahyoid muscles in healthy subjects
Scientific Title:Acronym
Power-assisted electrical stimulation for suprahyoid muscles
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check whether or not the power assisted electrical stimulation in addition to usual muscle strengthening program increase the muscle forces in suprahyoid muscles
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
isometric muscle force
Integrated electromyography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
muscle strengthening exercise
Interventions/Control_2
muscle strengthening exercise +electrical stimulation
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
healthy subjects
Key exclusion criteria
dysphagia
stroke
neuromuscular disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Saitoh |
Organization
Fujita Health University
Division name
Rehabilitation I
Zip code
Address
1-98 Dengakugakubo, Kutsukake,Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2167
esaitoh@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Kagaya |
Organization
Fujita Health University
Division name
Rehabilitation I
Zip code
Address
1-98 Dengakugakubo, Kutsukake,Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2167
Homepage URL
hkagaya2@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019721
