UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of insoles with a toe-grip bar on toe function and standing balance in healthy individuals
Title of the study (Brief title)	Insoles with toe-grip bar improve toe function and standing balance
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of insoles with a toe-grip bar on toe function and standing balance in healthy individuals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Toe-grip strength, toe flexibility, total trajectory length, envelop area, and functional reach
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	Other
Interventions/Control_1	Insoles with toe-grip bar
Interventions/Control_2	Standard insoles
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	19 years-old <=
Age-upper limit	22 years-old >
Gender	Female
Key inclusion criteria	Healthy women
Key exclusion criteria	Orthopedic disease, Neurological disease, Psychiatric disease
Target sample size	30

Research contact person
Name of lead principal investigator	Shin Murata
Organization	Kyoto Tachibana University
Division name	Faculty of Health Science
Address	34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto
TEL	+81-75-571-1111
Email	murata-s@tachibana-u.ac.jp

Public contact
Name of contact person	Hideki Nakano
Organization	Kyoto Tachibana University
Division name	Faculty of Health Science
Address	34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto
TEL	+81-75-571-1111
Homepage URL
Email	nakano-h@tachibana-u.ac.jp

Sponsor
Institute	Kyoto Tachibana University
Institute
Department

Funding Source
Organization	Kyoto Tachibana University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 03 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 19 Day
Anticipated trial start date	2016 Year 07 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 25 Day
Last modified on	2017 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030651