UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037378
Receipt number R000042518
Scientific Title Effect of 'Toe Exercises' and 'morphological variation of the foot and walking' in kinematic study
Date of disclosure of the study information 2019/07/16
Last modified on 2019/07/15 00:05:35

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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 or person

Institute

Gunma PAZ University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042518


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name