UMIN-CTR Clinical Trial

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