UMIN-CTR Clinical Trial

Basic information
Public title	Involvement of autonomic nervous system regulation in modulation of joint position sense by an above-knee compression garment
Acronym	Compression garment effect on joint position sense and autonomic nervous system
Scientific Title	Involvement of autonomic nervous system regulation in modulation of joint position sense by an above-knee compression garment
Scientific Title:Acronym	Compression garment effect on joint position sense and autonomic nervous system
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines whether emotional changes that transiently modulate autonomic nervous activity may be involved in the joint position sense effect of compression garment.
Basic objectives2	Others
Basic objectives -Others	An above knee compression garment was identified as to blunt joint position sense. This study examines whether emotional changes that transiently modulate autonomic nervous activity may be involved in the joint position sense effect of compression garment.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Joint position sense
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Above knee compression garment
Interventions/Control_2	emotional stimulus (music)
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	45 years-old >
Gender	Male and Female
Key inclusion criteria	No neuromotor deficit, No musculoskeletal deficit RIght handed
Key exclusion criteria	Neuromotor deficit, Musculoskeletal deficit Left handed
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL	022-717-8586
Email	nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL	022-717-8586
Homepage URL
Email	nagatomi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Biomedical Engineering
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	Seiryo 2-1, Aoba-ku, Sendai, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2022 Year 09 Month 15 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	2022 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 15 Day
Last follow-up date	2023 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	2022 Year 09 Month 02 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055596