UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042189
Receipt number R000048161
Scientific Title Intrinsic versus extrinsic foot muscles exercises for flexible flatfoot in adolescents: Randomized controlled trial
Date of disclosure of the study information 2020/12/01
Last modified on 2020/10/21 14:45:37

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Basic information

Public title

Intrinsic versus extrinsic foot muscles exercises for flexible flatfoot in adolescents: Randomized controlled trial

Acronym

Exercises for flatfoot

Scientific Title

Intrinsic versus extrinsic foot muscles exercises for flexible flatfoot in adolescents: Randomized controlled trial

Scientific Title:Acronym

Exercises for flatfoot

Region

Asia(except Japan)


Condition

Condition

Flatfoot

Classification by specialty

Rehabilitation medicine Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

compare the effectiveness of extrinsic and intrinsic foot muscle exercises in improving the medial longitudinal arch in adolescents with flat foot.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Navicular Drop

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

corrective exercises for eight weeks focusing on the extrinsic (EEG)

Interventions/Control_2

corrective exercises for eight weeks focusing on the intrinsic (IEG) muscles

Interventions/Control_3

No treatment

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

12 years-old <=

Age-upper limit

16 years-old >=

Gender

Male and Female

Key inclusion criteria

The inclusion criteria included the difference in the foot arch height of more than 10 mm in the weight-bearing and non-weight-bearing conditions, healthy weight, and no use of insole and orthoses or other therapeutic and exercise interventions that coincide with the current study.

Key exclusion criteria

excluded criteria were having a history of neurological, orthopedic, cardiovascular disease, and BMI outside the normal range.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Mehdi
Middle name
Last name Gheitasi

Organization

Shahid Beheshti University

Division name

Faculty of Sport Science & Health

Zip code

19839 69411

Address

Faculty of Sport Science & Health, Shahid Beheshti University, Velenjak, Daneshjoo Blvd., Tehran, Iran

TEL

+989123547613

Email

m_gheitasi@sbu.ac.ir


Public contact

Name of contact person

1st name Mohammad
Middle name
Last name Bayattork

Organization

University of Hormozgan

Division name

Faculty of Humanities Science

Zip code

7916193145

Address

Faculty of Humanities Science, University of Hormozgan, Bandar Abbas, Iran

TEL

+989155521005

Homepage URL


Email

mohammadbayat82@gmail.com


Sponsor or person

Institute

Azad University

Institute

Department

Personal name



Funding Source

Organization

No

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

Shahid Beheshti University

Address

Shahid Beheshti University, Velenjak, Daneshjoo Blvd., Tehran, Iran

Tel

021 29901

Email

m_gheitasi@sbu.ac.ir


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

2020 Year 12 Month 01 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

36

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

Completed

Date of protocol fixation

2019 Year 01 Month 01 Day

Date of IRB

2019 Year 10 Month 01 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2020 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 21 Day

Last modified on

2020 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048161


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name