UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043949
Receipt number R000050196
Scientific Title Effects of acupuncture stimulation of the thighs and buttocks on gait
Date of disclosure of the study information 2021/04/16
Last modified on 2021/04/16 15:17:33

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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 or person

Institute

Meiji University of Integrative Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050196


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name