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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024889
Receipt No. R000028583
Scientific Title The quantitative evaluation of muscle responses upon Belt electrode - Skeletal muscle Electrical Stimulation (B-SES), Study 1
Date of disclosure of the study information 2016/11/18
Last modified on 2019/03/29

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Basic information
Public title The quantitative evaluation of muscle responses upon Belt electrode - Skeletal muscle Electrical Stimulation (B-SES), Study 1
Acronym The standardization of protocol for B-SES, Study 1
Scientific Title The quantitative evaluation of muscle responses upon Belt electrode - Skeletal muscle Electrical Stimulation (B-SES), Study 1
Scientific Title:Acronym The standardization of protocol for B-SES, Study 1
Region
Japan

Condition
Condition Muscle weakness in lower limbs, femoral neck fracture, vertebral fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether Belt electrode - Skeletal muscle Electrical Stimulation (B-SES) induces humoral factors related to muscle strengthening in dose dependent manner.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Immediate changes in lactic acid and growth hormone in blood samples between pre- and post-stimulation.
Key secondary outcomes muscle power in lower limbs, Chair stand test, Thigh and Calf circumference, the actual stimulation value

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Lower limb muscle stimulation using Belt electrode - Skeletal muscle Electrical Stimulation is performed for 3 days as pre-test training. Then the stimulation is applied at "very strong" level for 20 min.
Interventions/Control_2 Lower limb muscle stimulation using Belt electrode - Skeletal muscle Electrical Stimulation is performed for 3 days as pre-test training. Then the stimulation is applied at "Strong" level for 20 min.
Interventions/Control_3 Lower limb muscle stimulation using Belt electrode - Skeletal muscle Electrical Stimulation is performed for 3 days as pre-test training. Then the stimulation is applied at "Moderate" level for 20 min.
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with lower limb muscle weakness, or risk of it, including patients with femoral neck fracture or vertebral fracture.
Key exclusion criteria Patients with pacemaker
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Ogata
Organization National Rehabilitation Center for Persons with Disabilities
Division name Center for Sport Science and Health Promotion
Zip code 359-8555
Address 4-1, Namiki, Tokorozawa, Saitama, Japan
TEL +81-4-2995-3100
Email toogata-tky@umin.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Ogata
Organization National Rehabilitation Center for Persons with Disabilities
Division name Center for Sport Science and Health Promotion
Zip code 359-8555
Address 4-1, Namiki, Tokorozawa, Saitama, Japan
TEL +81-4-2995-3100
Homepage URL
Email toogata-tky@umin.ac.jp

Sponsor
Institute National Rehabilitation Center for Persons with Disabilities
Institute
Department

Funding Source
Organization Japanese Research Society of Skeletal muscle Electrical Stimulation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Ethical committee, National Rehabilitation Center for Persons with Disabilities
Address 4-1, Namiki, Tokorozawa, Saitama
Tel 04-2995-3100
Email kikakurinri@rehab.go.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 新上三川病院(栃木県)、武蔵台病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 18 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 35
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
2016 Year 08 Month 08 Day
Date of IRB
2016 Year 03 Month 01 Day
Anticipated trial start date
2016 Year 09 Month 16 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 18 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028583

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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