UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052062
Receipt number R000059405
Scientific Title the mechanism of the effect of static stretching intervention for joint stiffness
Date of disclosure of the study information 2023/08/31
Last modified on 2025/03/02 19:12:15

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Basic information

Public title

the effect of static stretching for joint stiffness

Acronym

the effect of static stretching for joint stiffness

Scientific Title

the mechanism of the effect of static stretching intervention for joint stiffness

Scientific Title:Acronym

the mechanism of the effect of static stretching intervention for joint stiffness

Region

Japan


Condition

Condition

not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to investigate the soft tissue of which stiffness is related to the change of joint stiffness due to static stretching intervention.

Basic objectives2

Others

Basic objectives -Others

to investigate mechanism

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

we will measure range of motion, joint stiffness, shear modulus, and slack angle at the start of the intervention and 4 and 8 weeks after the start point.

Key secondary outcomes



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

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

2 minutes * 3 sets per day static stretching of ankle dorsiflexion is performed everyday. the participants performed the stretching as their home exercise. they performed it by putting their foot of intervention side and dorsiflexing their ankle until they feel the largest stretch that they were willing to tolerate.

Interventions/Control_2

any stretching maneuver for stretching is not performed.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

people who have neither orthopedic disease nor pain by passive or active movement of upper or lower limb.

Key exclusion criteria

people who have orthopedic disease or pain by passive or active movement of upper or lower limb.

Target sample size

54


Research contact person

Name of lead principal investigator

1st name Noriaki
Middle name
Last name Ichihashi

Organization

Kyoto University graduate school of medicine

Division name

Human Health Science

Zip code

606-8397

Address

53 Shogoin-Kawahara-cho, Kyoto

TEL

075-751-3951

Email

ichihashi.noriaki.5z@kyoto-u.ac.jp


Public contact

Name of contact person

1st name Hiyu
Middle name
Last name Mukai

Organization

Kyoto University graduate school of medicine

Division name

Human Health Science

Zip code

606-8397

Address

53 Shogoin-Kawahara-cho, Kyoto

TEL

080-2998-8328

Homepage URL


Email

mukai.hiyuu.75s@st.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University graduate school of medicine

Institute

Department

Personal name

Ichihashi Noriaki


Funding Source

Organization

Kyoto University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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

2023 Year 08 Month 31 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

2023 Year 08 Month 30 Day

Date of IRB

2023 Year 10 Month 03 Day

Anticipated trial start date

2023 Year 10 Month 31 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

2023 Year 08 Month 30 Day

Last modified on

2025 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059405