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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048113
Receipt No. R000054836
Scientific Title The effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction
Date of disclosure of the study information 2022/08/01
Last modified on 2022/06/20

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Basic information
Public title The effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction
Acronym The effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction
Scientific Title The effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction
Scientific Title:Acronym The effects of intrinsic foot muscle strengthening training with neuromuscular electrical stimulation and blood flow restriction
Region
Japan

Condition
Condition Impairment of the foot
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of a training method that combines blood flow restriction and neuromuscular electrical stimulation as a muscle strengthening exercise for the intrinsic foot muscles.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle cross-sectional area
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Neuromuscular electrical stimulation with blood flow restriction
Interventions/Control_2 Neuromuscular electrical stimulation
Interventions/Control_3 Plasebo with blood flow restriction
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
30 years-old >=
Gender Male and Female
Key inclusion criteria Healthy college student
Key exclusion criteria Abnormal blood pressure
Anemia
Exercise restrictions by doctors
Cardiovascular disease
Varicose vein
Lymphedema
Diabetes
Cancer
Kidney disease
History of stroke or seizure
Infection
Skin fragility
Lower limb injury
Surgical history less than a year ago
During menstruation / pregnancy (women only)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazunori
Middle name
Last name Okamura
Organization Prefectural University of Hiroshima
Division name Faculty of Health and Welfare
Zip code 7230053
Address 1-1 Gakuen-cho, Mihara-shi, Hiroshima
TEL 0848601225
Email k-okamura@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name Kazunori
Middle name
Last name Okamura
Organization Prefectural University of Hiroshima
Division name Faculty of Health and Welfare
Zip code 723-0053
Address 1-1 Gakuen-cho, Mihara-shi, Hiroshima
TEL 0848601225
Homepage URL
Email k-okamura@pu-hiroshima.ac.jp

Sponsor
Institute Prefectural University of Hiroshima
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Prefectural University of Hiroshima
Address 1-1 Gakuen-cho, Mihara-shi, Hiroshima
Tel 0848601225
Email k-okamura@pu-hiroshima.ac.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

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2022 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 20 Day
Last modified on
2022 Year 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054836

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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