UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032761
Receipt number R000037374
Scientific Title The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait
Date of disclosure of the study information 2018/05/31
Last modified on 2020/02/05 19:52:10

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Basic information

Public title

The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait

Acronym

The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait

Scientific Title

The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait

Scientific Title:Acronym

The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait

Region

Japan


Condition

Condition

Flat Foot

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of intrinsic foot muscle training on medial longitudinal arch dynamics
during gait.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Medial longitudinal arch dynamics
during gait assessed by the three dimensional motion analysis.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Intrinsic foot muscle training

Interventions/Control_2

no treatment

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

Male and Female

Key inclusion criteria

Flat foot

Key exclusion criteria

pain, neurologic disease

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kazunori
Middle name
Last name Okamura

Organization

Prefectural University of Hiroshima

Division name

Faculty of Health and Welfare

Zip code

723-0053

Address

1-1 Gakuen-cho, Mihara-shi, Hiroshima 723-0053, Japan

TEL

0848-60-1225

Email

k-okamura@pu-hiroshima.ac.jp


Public contact

Name of contact person

1st name Kazunori
Middle name
Last name Okamura

Organization

Prefectural University of Hiroshima

Division name

Faculty of Health and Welfare

Zip code

723-0053

Address

1-1 Gakuen-cho, Mihara-shi, Hiroshima 723-0053, Japan

TEL

0848-60-1225

Homepage URL


Email

k-okamura@pu-hiroshima.ac.jp


Sponsor or person

Institute

Prefectural University of Hiroshima

Institute

Department

Personal name



Funding Source

Organization

Prefectural University of Hiroshima

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

Ethics Committee of the Prefectural University of Hiroshima

Address

1-1 Gakuen-cho, Mihara-shi

Tel

0848-60-1120

Email

k-okamura@pu-hiroshima.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

2018 Year 05 Month 31 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

20

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

Open public recruiting

Date of protocol fixation

2018 Year 05 Month 30 Day

Date of IRB

2018 Year 08 Month 29 Day

Anticipated trial start date

2018 Year 08 Month 30 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 29 Day

Last modified on

2020 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037374


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name