UMIN-CTR Clinical Trial

Basic information
Public title	Morphologic Relationship between Toe Exercises and Medial Longitudinal Arch
Acronym	Morphologic Relationship between Toe Exercises and Medial Longitudinal Arch
Scientific Title	Effect of 'Toe Exercises' and 'morphological variation of the foot and walking' in kinematic study
Scientific Title:Acronym	Effect of 'Toe Exercises' and 'morphological variation of the foot and walking' in kinematic study
Region	Japan

Condition
Condition	flat foot,pes planus
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate the relationship between toe exercises and morphological variations of the medial longitudinal arch of the foot.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the Modified navicular drop test arch height index
Key secondary outcomes	range of dorsiflexion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	towel curl exercise group 3 times a day for 3 min Period:5weeks
Interventions/Control_2	great toe exercise group Repetition: the exercise in sets of 10, 3 times a day. Period:5weeks
Interventions/Control_3	lesser toe exercise group Repetition: the exercise in sets of 10, 3 times a day. Period:5weeks
Interventions/Control_4	control group Period:5weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	A sample of 40 subjects (20 men and 20 women) volunteered for the study. None of the subjects had prior personal experience with the toe exercise training utilized in the study.
Key exclusion criteria	The study exclusion criteria were any sign of leg pain, medical history, and evidence of musculoskeletal disease or neurological disease within the previous 6 months that could affect the motor function.
Target sample size	180

Research contact person
Name of lead principal investigator	1st name takashi Middle name Last name shiroshita
Organization	Gunma PAZ University
Division name	School of Physical Therapy, Faculty of Health Science,
Zip code	370-0006
Address	1-7-1 Tonyamachi, Takasaki-shi 370-0006, Gunma, Japan
TEL	027-388-0952
Email	shiroshita@paz.ac.jp

Public contact
Name of contact person	1st name takashi Middle name Last name shiroshita
Organization	Gunma PAZ University
Division name	School of Physical Therapy, Faculty of Health Science,
Zip code	370-0006
Address	603Lab 1-7-1 Tonyamachi, Takasaki-shi 370-0006, Gunma, Japan
TEL	027-388-0952
Homepage URL
Email	shiroshita@paz.ac.jp

Sponsor
Institute	Gunma PAZ University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	ethics review committee on research with human subjects gunma paz university
Address	1-7-1 Tonyamachi, Takasaki-shi 370-0006, Gunma, Japan
Tel	027-365-3366
Email	naka@paz.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	群馬パース大学保健科学部理学療法学科

Other administrative information
Date of disclosure of the study information	2019 Year 07 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	78
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	We analyze data many times at present and are preparing for this paper submitting.
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	2013 Year 01 Month 16 Day
Date of IRB	2012 Year 10 Month 28 Day
Anticipated trial start date	2013 Year 01 Month 16 Day
Last follow-up date	2018 Year 12 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 15 Day
Last modified on	2019 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042518