UMIN-CTR Clinical Trial

Basic information
Public title	Changes in lower limb muscle activity and trunk acceleration during walking due to different footwear.
Acronym	Changes in lower limb muscle activity and trunk acceleration during walking due to different footwear.
Scientific Title	Changes in lower limb muscle activity and trunk acceleration during walking due to different footwear.
Scientific Title:Acronym	Changes in lower limb muscle activity and trunk acceleration during walking due to different footwear.
Region	Japan

Condition
Condition	Healthy female college student
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to investigate the relationship between types of footwear and changes in lower limb muscle activity and trunk acceleration.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	lower limb tendon activity, trunk acceleration, gait speed, step length
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <=
Age-upper limit	40 years-old >
Gender	Female
Key inclusion criteria	Healthy female college student
Key exclusion criteria	people with severe deformity, pain, history of trauma, surgery, neurological symptoms, in the lower extremities that may affect walking
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuuka Middle name Last name Yasuura
Organization	Kio University Graduate School
Division name	Department of Health Sciences
Zip code	635-0832
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL	0745541601
Email	P1311071@kio.ac.jp

Public contact
Name of contact person	1st name Yuuka Middle name Last name Yasuura
Organization	Kio University Graduate School
Division name	Department of Health Sciences
Zip code	635-0832
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL	0745541601
Homepage URL
Email	P1311071@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
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	Kio University
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel	0745541601
Email	P1311071@kio.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 12 Month 01 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	30
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 09 Month 01 Day
Date of IRB	2022 Year 11 Month 30 Day
Anticipated trial start date	2022 Year 12 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Data collected through March 31, 2024 will be used.

Management information
Registered date	2022 Year 11 Month 08 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056310