UMIN-CTR Clinical Trial

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
Last 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
1st 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