UMIN-CTR Clinical Trial

Public title

The characteristic of arch height and influence of dynamic balance by intervention of exercise in flatfoot.

Acronym

The characteristic of arch height and influence by intervention of exercise in flatfoot.

Scientific Title

The characteristic of arch height and influence of dynamic balance by intervention of exercise in flatfoot.

Scientific Title:Acronym

The characteristic of arch height and influence by intervention of exercise in flatfoot.

Region

Japan

Condition

flatfoot

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. The investigation of characteristic of arch height in ages and habit of exercise.
2. The investigation of persistent effect after the intervention by short foot exercise.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1.Questionnaire:name,gender,age,dominant side,history of exercise,medical history
2.Height
3.Weight
4.Foot shape
5.Center of pressure in testing Y-Balance Test(Before intervention and after four weeks)

Key secondary outcomes

None

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Measurement periods set of this research are 3 times, and is total of 6 weeks. Short foot exercise is guided in the 1st time of measurement for classified flat foot group. Short foot exercise is the movement that the contraction of foot intrinsic muscle which shortens foot assembly. The movement maintain for 10 seconds, take a rest for 5 seconds and repeat in 30 minutes. Doing this exercise 3 times a week until the 2nd time of measurement for 4 weeks. The 3rd time will be measured 2 weeks later. Make sure that flat foot group won't do Short foot exercise after the 2nd time of measurement until the 3rd time of measurement.

Interventions/Control_2

Measurement periods set of this research are 3 times, and is total of 6 weeks. No intervention is guided in the 1st time of measurement for control group.The 2nd time of measurement will be measured 4 weeks later.The 3rd time will be measured 2 weeks later of The 2nd time of measurement.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

30

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Can stand independently.
2.No history of fructure in lower extremity.
3.No sport training in lower extremity.
4.No systemic disease.

Key exclusion criteria

When the person in charge or the object judges that couldn't continue the measurment, the measurment is stopped immediately.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	KUO SHU HAN

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

Address

2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan

TEL

070-2178-3657

Email

shokan0714@hotmail.com

Name of contact person

1st name
Middle name
Last name	KUO SHU HAN

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

Address

2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan

TEL

070-2178-3657

Homepage URL

Email

shokan0714@hotmail.com

Institute

Waseda University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

The relationship between arch height index and age is increasing before age of 40, and starts to decline from age of 40, and the relationship between arch height index and BMI is declined in excess weight.
The arch height index in male was higher than in females.
The trail of COP in the ML direction of flatfoot was narrower than that of neutral foot.The intervention of SFE for four weeks could effectively improve the arch height and maintain the height for at least three weeks.

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

01

Month

30

Day

Date of IRB

Anticipated trial start date

2018

Year

04

Month

30

Day

Last follow-up date

2019

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

04

Month

20

Day

Last modified on

2019

Year

02

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036642