UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061739 |
|---|---|
| Receipt number | R000070657 |
| Scientific Title | The Effect of a Six-Week Corrective Exercise Program on Plantar Pressure Distribution and Dynamic Balance in Young Male Soccer Players with Flexible Pes Planus |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/05/29 17:16:57 |
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Basic information
Public title
The Effect of a Six-Week Corrective Exercise Program on Plantar Pressure Distribution and Dynamic Balance in Young Male Soccer Players with Flexible Pes Planus
Acronym
The Effect of a Six-Week Corrective Exercise Program on Plantar Pressure Distribution and Dynamic Balance in Young Male Soccer Players with Flexible Pes Planus
Scientific Title
The Effect of a Six-Week Corrective Exercise Program on Plantar Pressure Distribution and Dynamic Balance in Young Male Soccer Players with Flexible Pes Planus
Scientific Title:Acronym
The Effect of a Six-Week Corrective Exercise Program on Plantar Pressure Distribution and Dynamic Balance in Young Male Soccer Players with Flexible Pes Planus
Region
| Asia(except Japan) |
Condition
Condition
pre-post
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is a two-arm, parallel-group, randomized controlled trial designed to evaluate the effect of a six-week corrective exercise program on plantar pressure distribution and dynamic balance in young male soccer players with flexible flatfoot. Participants (n=40) aged 10 to 15 years were randomly assigned to either a corrective exercise group (n=20) or a control group (n=20). The primary outcomes are peak plantar pressure (kPa) in the forefoot and heel regions and the Center of Pressure Excursion Index (CPEI). The secondary outcome is dynamic balance measured by the Y Balance Test composite score. All outcomes were assessed at baseline and immediately post-intervention (6 weeks).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in peak plantar pressure (kPa) in the forefoot region (forefoot) measured by a plantar pressure plate (PT-Scan, Payafzafan Ferdowsi, Iran) during static standing.Change in peak plantar pressure (kPa) in the heel region (rearfoot) measured by a plantar pressure plate during static standing.
Key secondary outcomes
Change in dynamic balance assessed by the Y Balance Test (YBT) composite score (normalized to limb length).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the experimental group performed a six week corrective exercise program
Interventions/Control_2
Participants in the control group
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male
Key inclusion criteria
Male sex
Age 10 to 15 years
Active participation in a football club or school team for at least two years, with a minimum of three training sessions per week
Confirmed flexible flatfoot based on both.
Key exclusion criteria
Presence of systemic or neuromuscular disorders (cerebral palsy, spina bifida, peripheral neuropathy, vestibular disorders, rheumatoid arthritis, lupus, diabetes mellitus)
History of severe lower extremity injury within the past year (fracture) or within the past two years (anterior cruciate ligament rupture, meniscus tear, ankle dislocation)
Obvious lower limb deformities such as cavus foot, knee varus valgus (abnormal Q angle), or leg length discrepancy greater than cm confirmed by an orthopedic specialist
Limited ankle dorsiflexion range of motion (less than with knee fully extended).
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Sogand |
| Middle name | |
| Last name | Alizadeh |
Organization
shomal university
Division name
SU
Zip code
4717647745
Address
Amol, Iran
TEL
989115964156
Sogand.aliiz@gmail.com
Public contact
Name of contact person
| 1st name | Sogand |
| Middle name | |
| Last name | Alizadeh |
Organization
Shomal university
Division name
sh
Zip code
4717647745
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
Sogand.aliiz@gmail.com
Sponsor or person
Institute
self funding
Institute
Department
Personal name
Funding Source
Organization
self funding
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
phyical education
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
Tel
989336487376
amirehsanbakhshandeh@gmail.com
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
| 2026 | Year | 06 | Month | 16 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070657
