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
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
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
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
