UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024889
Receipt number 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 10:46:01

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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 or person

Institute

National Rehabilitation Center for Persons with Disabilities

Institute

Department

Personal name



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

Value
https://center6.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