UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061327 |
|---|---|
| Receipt number | R000070174 |
| Scientific Title | Effects of Short Foot Exercises With and Without Blood Flow Restriction on Foot Posture Index, Sensory Organization, and Center of Pressure Displacement in Middle-Aged Women With Flexible Flatfoot: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/21 00:38:05 |
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Basic information
Public title
Effects of Short Foot Exercises With and Without Blood Flow Restriction on Foot Posture Index, Sensory Organization, and Center of Pressure Displacement in Middle-Aged Women With Flexible Flatfoot: A Randomized Controlled Trial
Acronym
Effects of Short Foot Exercises With and Without Blood Flow Restriction on Foot Posture Index, Sensory Organization, and Center of Pressure Displacement in Middle-Aged Women With Flexible Flatfoot: A Randomized Controlled Trial
Scientific Title
Effects of Short Foot Exercises With and Without Blood Flow Restriction on Foot Posture Index, Sensory Organization, and Center of Pressure Displacement in Middle-Aged Women With Flexible Flatfoot: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Short Foot Exercises With and Without Blood Flow Restriction on Foot Posture Index, Sensory Organization, and Center of Pressure Displacement in Middle-Aged Women With Flexible Flatfoot: A Randomized Controlled Trial
Region
| Asia(except Japan) | South America | Australia |
Condition
Condition
per-post test
Classification by specialty
| Neurology | Blood transfusion | Rehabilitation medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this randomized controlled trial was to compare the effects of six weeks of short foot exercises (SFE) performed with and without blood flow restriction (BFR) on the Foot Posture Index in middle-aged women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Foot Posture Index (FPI)
Key secondary outcomes
Sensory Organization and Balance Scores
Composite equilibrium score and individual scores in the six conditions of the Sensory Organization Test (SOT) using NeuroCom dynamic posturography.
Center of Pressure (COP) Displacement
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
| Medicine |
Interventions/Control_1
short foot exercises (SFE) performed with blood flow restriction (BFR)
Interventions/Control_2
short foot exercises (SFE) performed without blood flow restriction (BFR)
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
| 35 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Flexible flatfoot with Foot Posture Index more 6,No history of lower limb surgery or severe deformity, No neurological or musculoskeletal disorders affecting balance or gait, No contraindications to blood flow restriction training
Key exclusion criteria
History of foot/ankle surgery,Lower limb pain or injury,
Severe foot deformities (e.g., hallux valgus, rigid flatfoot), Neurological or neuromuscular disorders, Hypertension, varicose veins, or vascular diseases,Chronic ankle instability or degenerative joint disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Qazal |
| Middle name | |
| Last name | Marvastinia |
Organization
Islamic Azad University, East Tehran Branch, Tehran
Division name
IAUETB
Zip code
1491115719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989123547613
Qazal.marvastinia@gmail.com
Public contact
Name of contact person
| 1st name | Ghazal |
| Middle name | |
| Last name | Marvastinia |
Organization
Islamic Azad University, East Tehran Branch, Tehran
Division name
IAUETB
Zip code
1491115719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
Qazal.marvastinia@gmail.com
Sponsor or person
Institute
IAUETB
Institute
Department
Personal name
Funding Source
Organization
SELF FUNDING
Organization
Division
Category of Funding Organization
Self funding
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
Qazal.marvastinia@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 | 04 | Month | 30 | 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 | 02 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 25 | 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 | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070174
