UMIN-CTR Clinical Trial

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
Email	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
Email	ntakeuchi@takasaki-u.ac.jp

Sponsor
Institute	Takasaki University of Health and Welfare
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021991