UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019012 |
|---|---|
| Receipt number | R000021991 |
| Scientific Title | The study of association between the muscle tone and tissue hemodynamics, and the study of effect of high intensity pulse irradiation with linear polarized near-infrared rays on muscle strength and tissue hemodynamics |
| Date of disclosure of the study information | 2015/09/20 |
| Last modified on | 2020/03/19 13:13:55 |
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Basic information
Public title
The study of association between the muscle tone and tissue hemodynamics, and the study of effect of high intensity pulse irradiation with linear polarized near-infrared rays on muscle strength and tissue hemodynamics
Acronym
The study of association between the muscle tone and tissue hemodynamics, and the study of effect of HI-LPNR on muscle strength and tissue hemodynamics
Scientific Title
The study of association between the muscle tone and tissue hemodynamics, and the study of effect of high intensity pulse irradiation with linear polarized near-infrared rays on muscle strength and tissue hemodynamics
Scientific Title:Acronym
The study of association between the muscle tone and tissue hemodynamics, and the study of effect of HI-LPNR on muscle strength and tissue hemodynamics
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the association between the muscle tone and tissue hemodynamics.
Verify the effect of HI-LPNR irradiation on muscle strength and tissue hemodynamics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue hemodynamics at pre and post intervention.
Key secondary outcomes
Range of motion and muscle strength at pre and post intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
HI-LPNR irradiation of the muscle (5 min)
Interventions/Control_2
HI-LPNR irradiation of the nerve (5 min)
Interventions/Control_3
control
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Those who have a history of disease in the lower extremities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma
TEL
027-352-1291
ntakeuchi@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma
TEL
027-352-1291
Homepage URL
ntakeuchi@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 09 | Month | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021991
