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
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
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
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
