UMIN-CTR Clinical Trial

Basic information
Public title	Effects of acupuncture stimulation of the thighs and buttocks on gait
Acronym	Effects of acupuncture stimulation of the thighs and buttocks on gait
Scientific Title	Effects of acupuncture stimulation of the thighs and buttocks on gait
Scientific Title:Acronym	Effects of acupuncture stimulation of the thighs and buttocks on gait
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to examine whether acupuncture stimulation on the thighs and buttocks has any effect on gait in healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Three-dimensional motion analysis
Key secondary outcomes	Spine alignment, Salivary serotonin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Acupuncture
Interventions/Control_2	No Treatment
Interventions/Control_3
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Subjects who are healthy adult, aged 20 to 69 years. 2.Subjects who give informed consent.
Key exclusion criteria	The exclusion criteria are (i) diseases, symptoms, medical abnormalities, or medical histories that would affect the results of this study; (ii) use of drugs or dietary supplements with the potential to affect the results of this study; and (iii) lifestyle-related diseases.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shuhei Middle name Last name Kawaguchi
Organization	Meiji University of Integrative Medicine
Division name	Graduate School of Acupuncture and Moxibustion
Zip code	6290392
Address	Hiyoshi, Nantan, Kyoto
TEL	0771721181
Email	20191302@meiji-u.ac.jp

Public contact
Name of contact person	1st name Shuhei Middle name Last name Kawaguchi
Organization	Meiji University of Integrative Medicine
Division name	Graduate School of Acupuncture and Moxibustion
Zip code	6290392
Address	Hiyoshi, Nantan, Kyoto
TEL	0771721181
Homepage URL
Email	20191302@meiji-u.ac.jp

Sponsor
Institute	Meiji University of Integrative Medicine
Institute
Department

Funding Source
Organization	Meiji University of Integrative Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Meiji University of Integrative Medicine
Address	Hiyoshi, Nantan, Kyoto
Tel	0771721181
Email	20191302@meiji-u.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	2021 Year 04 Month 16 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	2021 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 16 Day
Last follow-up date	2022 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	2021 Year 04 Month 16 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050196