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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031516
Receipt No. R000035985
Scientific Title Efficacy of electric field therapy in muscle flexibility and joint range of motion
Date of disclosure of the study information 2018/02/28
Last modified on 2019/03/04

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Basic information
Public title Efficacy of electric field therapy in muscle flexibility and joint range of motion
Acronym Effect of EF in muscle flexibility and joint range of motion
Scientific Title Efficacy of electric field therapy in muscle flexibility and joint range of motion
Scientific Title:Acronym Effect of EF in muscle flexibility and joint range of motion
Region
Japan

Condition
Condition Frailty and Sarcopenia, muscular pain
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of electric field therapy on the muscle flexibility
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes long seat body anteflexion before and after electric filed treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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
Device,equipment Behavior,custom
Interventions/Control_1 Sham,washout,EF
Interventions/Control_2 EF,washout,Sham
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Healthy male and female aged between 18 and 65 years old
Key exclusion criteria Subjects who are diagnosed with heart disease and are restricted from extreme exercise in daily life.
Subjects who is using electrical equipment susceptible to electromagnetic interference.
Subjects who is using wearable type electrical equipment.
Subjects who have malignant tumor.
Subjects who have heart disease.
Subjects at early pregnancy or shortly after delivery.
Subjects with a body temperature above 38 degrees Celsius.
Subjects who need rest.
Subject who have a acute pain.
Subjects with perceptual disorder.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Harakawa
Organization National University Corporation Obihiro University of Agriculture and Veterinary Medicine
Division name Bio-Self-Regulating Science Laboratory
Zip code
Address 11 Nishi 2, Inadacho, Obihiro, Hokkaido
TEL 0155-49-5644
Email sharakawa_hakuju@obihiro.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Harakawa
Organization National University Corporation Obihiro University of Agriculture and Veterinary Medicine
Division name Bio-Self-Regulating Science Laboratory
Zip code
Address 11 Nishi 2, Inadacho, Obihiro, Hokkaido
TEL 0155-49-5644
Homepage URL
Email sharakawa_hakuju@obihiro.ac.jp

Sponsor
Institute Obihiro University of Agriculture and Veterinary Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 28 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 28 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 02 Month 28 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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