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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042189
Receipt No. 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

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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
Institute Azad University
Institute
Department

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
URL(English) https://upload.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


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