Flexible FlatfootNCT06861322
Effects of Short Foot Exercise on Knee Pain, Muscle Tone, Balance, and Quality of Life in Flexible Flatfoot Patients
A study testing Short Foot Exercise and Conventional Physical Therapy in people with Flexible Flatfoot and Knee Pain, run by Sahmyook University at 1 site in South Korea.
Trial summary
This study was a clinical trial to investigate the effects of Short Foot Exercise (SFE) and standard physical therapy on knee muscle tone, knee pain and function, balance ability, and quality of life in adults with flexible flat feet and knee pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Flexible Flatfoot, Knee Pain, Balance Impairment
- What is being tested?
- Short Foot Exercise and Conventional Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI (Body Mass Index): If between 18 and 25 kg/m²
- Litigation period: If knee pain lasted for more than 6 weeks
- Navicular drop test: If it was 10 mm or more
- Numerical assessment scale: If knee pain was 4 or more
- Health status: If you are a person without health problems and are trying to participate in the experiment
Who cannot join
- History of knee surgery: If you have had knee surgery
- Treatment history: If you have received physical therapy for knee pain in the 4 weeks before the start of the study
- Mental status: If you have a psychological disorder that may interfere with your participation in the study
- Injury status: If you have a current serious injury affecting the lower extremity joints and foot
- Lower extremity alignment abnormalities and specific conditions: If you have structural flat foot, scoliosis
- Diseases and other conditions: If you have diabetes, rheumatoid arthritis, or menopause
- Neurological disorders: If you have experienced a neurological disorder within the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samyuk University
Seoul, Nowon-gu, 01795
lee eungjoon, +8201028850431, dmdwns777@naver.com
About this study
Official title: The Effects of Short Foot Exercises on Knee Muscle Tone, Knee Pain and Function, Balance, and Quality of Life in Patients with Flexible Flat Foot with Knee Pain
This study was a clinical trial to investigate the effects of Short Foot Exercise (SFE) and standard physical therapy on knee muscle tone, knee pain and function, balance ability, and quality of life in adults with flexible flat feet and knee pain.
Read the detailed description
This study aims to determine whether strengthening foot intrinsic muscles through SFE can reduce knee pain, improve muscle function, enhance balance, and improve quality of life in individuals with flexible flatfoot. Results may provide evidence-based rehabilitation strategies for managing knee pain in these patients.
- Being tested
- Short Foot Exercise, Conventional Physical Therapy
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Foot ExerciseBehavioural
- Description: Short Foot Exercise is a therapeutic exercise designed to strengthen intrinsic foot muscles and improve medial longitudinal arch stability.
- Procedure: Participants will perform Short Foot Exercise twice daily, five times per week for four weeks. The exercise consists of progressive phases, starting with basic foot activation and advancing to resistance-based strengthening using bands.
- Purpose: To determine if strengthening the foot's intrinsic muscles positively impacts knee pain, muscle function, and balance in individuals with flexible flatfoot.
Conventional Physical TherapyBehavioural
- Description: Standard non-invasive physical therapy aimed at reducing knee pain, improving muscle relaxation, and enhancing lower limb function.
- Procedure: Participants will receive twice-weekly conventional physical therapy for ten minutes per session over four weeks. Treatment includes soft tissue mobilization, muscle relaxation techniques, and neuromuscular stimulation, as appropriate for knee pain relief.
- Purpose: To evaluate its effectiveness as a standalone treatment compared to the addition of Short Foot Exercise.
| Study group | Role | What they receive |
|---|---|---|
| Short Foot Exercise + Conventional Physical Therapy | Experimental | Participants in this group will receive Short Foot Exercise (SFE) combined with Conventional Physical Therapy for four weeks.
This intervention combination aims to determine whether Short Foot Exercise, in addition to conventional physical therapy, provides greater improvements in knee pain, muscle tone, balance, and quality of life compared to physical therapy alone. Receives: Behavioral: Short Foot Exercise; Behavioral: Conventional Physical Therapy |
| Conventional Physical Therapy | Active comparator | Participants in this group will receive Conventional Physical Therapy only for four weeks.
This control group serves as a baseline comparator, allowing researchers to assess whether adding Short Foot Exercise to conventional therapy provides additional benefits for knee pain, muscle function, balance, and quality of life. Receives: Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Muscle Tension from Baseline to 4 Weeks (Measured by Myoton Pro - Frequency in Hz)
- Description: This outcome measure assesses changes in muscle tension (tone) in the knee region before and after the intervention.
- Measurement Tool: Myoton Pro
- Unit of Measure: Frequency (Hz)
- Assessment Method: Myoton Pro applies a gentle mechanical impulse to the skin overlying the Vastus Medialis, Biceps Femoris, Gastrocnemius Medialis, and Tibialis Anterior muscles, recording oscillation frequency as an indicator of muscle tone.
Measured: From enrollment to the end of treatment at 4 weeks
Change in Knee Muscle Stiffness from Baseline to 4 Weeks (Measured by Myoton Pro - Stiffness in N/m)
- Description: This measure evaluates changes in muscle stiffness, reflecting muscle resistance to external force.
- Measurement Tool: Myoton Pro
- Unit of Measure: Newton per meter (N/m)
- Assessment Method: Stiffness is quantified by Myoton Pro by applying a controlled impulse and measuring the muscle's resistance to deformation.
Measured: From enrollment to the end of treatment at 4 weeks
Change in Knee Muscle Elasticity from Baseline to 4 Weeks (Measured by Myoton Pro - Logarithmic Decrement)
- Description: This measure evaluates changes in muscle elasticity, which indicates the muscle's ability to return to its original shape after deformation.
- Measurement Tool: Myoton Pro
- Unit of Measure: Logarithmic decrement
- Assessment Method: The Myoton Pro records how quickly oscillations in the muscle dampen after a mechanical impulse, representing its elasticity.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (4)
Change in Dynamic Balance from Baseline to 4 Weeks (Measured by Y-Balance Test - Reach Distance in cm)
- Description: This measure assesses changes in lower limb balance and stability using the Y-Balance Test (YBT).
- Measurement Tool: Y-Balance Test (YBT)
- Unit of Measure: Reach distance (cm)
- Assessment Method: Participants will perform three reach directions (anterior, posteromedial, posterolateral) while maintaining single-leg stance. The maximum reach distance for each direction is recorded and averaged.
Measured: From enrollment to the end of treatment at 4 weeks
Change in Quality of Life from Baseline to 4 Weeks (Measured by EQ-5D-5L - Score on a 5-Dimension Scale)
- Description: This outcome measure evaluates self-reported quality of life in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
- Measurement Tool: EQ-5D-5L
- Unit of Measure: Score on a 5-Dimension Scale
- Assessment Method: Participants rate their health status on a 5-level Likert scale (1 = No problems, 5 = Extreme problems). A total EQ-5D-5L index score is calculated using a weighted algorithm.
Measured: From enrollment to the end of treatment at 4 weeks
Change in Knee Pain from Baseline to 4 Weeks (Measured by WOMAC Pain Subscale - Score on a 5-Point Likert Scale)
- Description: This measure evaluates knee pain severity before and after treatment.
- Measurement Tool: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale
- Unit of Measure: Score on a 5-Point Likert Scale
- Assessment Method: Participants rate pain intensity across five activities (e.g., walking, climbing stairs) using a 0-4 scale (0 = No pain, 4 = Extreme pain).
Measured: From enrollment to the end of treatment at 4 weeks
Change in Knee Function from Baseline to 4 Weeks (Measured by WOMAC Function Subscale - Score on a 5-Point Likert Scale)
- Description: This measure assesses changes in functional ability and movement limitations.
- Measurement Tool: WOMAC - Function Subscale
- Unit of Measure: Score on a 5-Point Likert Scale
- Assessment Method: Participants rate functional difficulty in 17 daily activities (e.g., rising from a chair, bending) on a 0-4 scale (0 = No difficulty, 4 = Extreme difficulty).
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start2 Mar 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EUNGJOON LEE, Sahmyook University
- Investigators
- eungjoon lee, Study director, Samyuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861322
- Sponsor's protocol ID
- SYU 2025-01-016-003
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short Foot Exercises on Knee Muscle Tone, Knee Pain and Function, Balance, and Quality of Life in Patients with Flexible Flat Foot with Knee Pain
- ClinicalTrials.gov ID
- NCT06861322
- Acronym / sponsor ID
- SYU 2025-01-016-003
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 2 Mar 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a clinical trial to investigate the effects of Short Foot Exercise (SFE) and standard physical therapy on knee muscle tone, knee pain and function, balance ability, and quality of life in adults with flexible flat feet and knee pain.
Detailed description
This study aims to determine whether strengthening foot intrinsic muscles through SFE can reduce knee pain, improve muscle function, enhance balance, and improve quality of life in individuals with flexible flatfoot. Results may provide evidence-based rehabilitation strategies for managing knee pain in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Foot Exercise + Conventional Physical Therapy | Experimental | Behavioral: Short Foot Exercise, Behavioral: Conventional Physical TherapyParticipants in this group will receive Short Foot Exercise (SFE) combined with Conventional Physical Therapy for four weeks. This intervention combination aims to determine whether Short Foot Exercise, in addition to conventional physical therapy, provides greater improvements in knee pain, muscle tone, balance, and quality of life compared to physical therapy alone. |
| Conventional Physical Therapy | Active comparator | Behavioral: Conventional Physical TherapyParticipants in this group will receive Conventional Physical Therapy only for four weeks. This control group serves as a baseline comparator, allowing researchers to assess whether adding Short Foot Exercise to conventional therapy provides additional benefits for knee pain, muscle function, balance, and quality of life. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI (Body Mass Index): If between 18 and 25 kg/m²
- Litigation period: If knee pain lasted for more than 6 weeks
- Navicular drop test: If it was 10 mm or more
- Numerical assessment scale: If knee pain was 4 or more
- Health status: If you are a person without health problems and are trying to participate in the experiment
Key exclusion criteria (7 listed)
- History of knee surgery: If you have had knee surgery
- Treatment history: If you have received physical therapy for knee pain in the 4 weeks before the start of the study
- Mental status: If you have a psychological disorder that may interfere with your participation in the study
- Injury status: If you have a current serious injury affecting the lower extremity joints and foot
- Lower extremity alignment abnormalities and specific conditions: If you have structural flat foot, scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Foot Exercise* Description: Short Foot Exercise is a therapeutic exercise designed to strengthen intrinsic foot muscles and improve medial longitudinal arch stability. * Procedure: Participants will perform Short Foot Exercise twice daily, five times per week for four weeks. The exercise consists of progressive phases, starting with basic foot activation and advancing to resistance-based strengthening using bands. * Purpose: To determine if strengthening the foot's intrinsic muscles positively impacts knee pain, muscle function, and balance in individuals with flexible flatfoot. | Behavioural | Short Foot Exercise + Conventional Physical Therapy |
| Conventional Physical Therapy* Description: Standard non-invasive physical therapy aimed at reducing knee pain, improving muscle relaxation, and enhancing lower limb function. * Procedure: Participants will receive twice-weekly conventional physical therapy for ten minutes per session over four weeks. Treatment includes soft tissue mobilization, muscle relaxation techniques, and neuromuscular stimulation, as appropriate for knee pain relief. * Purpose: To evaluate its effectiveness as a standalone treatment compared to the addition of Short Foot Exercise. | Behavioural | Conventional Physical Therapy, Short Foot Exercise + Conventional Physical Therapy |
Primary outcome
Change in Knee Muscle Tension from Baseline to 4 Weeks (Measured by Myoton Pro - Frequency in Hz)
Time frame: From enrollment to the end of treatment at 4 weeks
* Description: This outcome measure assesses changes in muscle tension (tone) in the knee region before and after the intervention. * Measurement Tool: Myoton Pro * Unit of Measure: Frequency (Hz) * Assessment Method: Myoton Pro applies a gentle mechanical impulse to the skin overlying the Vastus Medialis, Biceps Femoris, Gastrocnemius Medialis, and Tibialis Anterior muscles, recording oscillation frequency as an indicator of muscle tone.
Change in Knee Muscle Stiffness from Baseline to 4 Weeks (Measured by Myoton Pro - Stiffness in N/m)
Time frame: From enrollment to the end of treatment at 4 weeks
* Description: This measure evaluates changes in muscle stiffness, reflecting muscle resistance to external force. * Measurement Tool: Myoton Pro * Unit of Measure: Newton per meter (N/m) * Assessment Method: Stiffness is quantified by Myoton Pro by applying a controlled impulse and measuring the muscle's resistance to deformation.
Change in Knee Muscle Elasticity from Baseline to 4 Weeks (Measured by Myoton Pro - Logarithmic Decrement)
Time frame: From enrollment to the end of treatment at 4 weeks
* Description: This measure evaluates changes in muscle elasticity, which indicates the muscle's ability to return to its original shape after deformation. * Measurement Tool: Myoton Pro * Unit of Measure: Logarithmic decrement * Assessment Method: The Myoton Pro records how quickly oscillations in the muscle dampen after a mechanical impulse, representing its elasticity.
4 secondary outcomes
Change in Dynamic Balance from Baseline to 4 Weeks (Measured by Y-Balance Test - Reach Distance in cm)
Time frame: From enrollment to the end of treatment at 4 weeks
Change in Quality of Life from Baseline to 4 Weeks (Measured by EQ-5D-5L - Score on a 5-Dimension Scale)
Time frame: From enrollment to the end of treatment at 4 weeks
Change in Knee Pain from Baseline to 4 Weeks (Measured by WOMAC Pain Subscale - Score on a 5-Point Likert Scale)
Time frame: From enrollment to the end of treatment at 4 weeks
Change in Knee Function from Baseline to 4 Weeks (Measured by WOMAC Function Subscale - Score on a 5-Point Likert Scale)
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Flexible Flatfoot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
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Active, not recruitingObservational study
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
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Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
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Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
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Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
eungjoon lee study director
Samyuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Foot Exercise and Conventional Physical Therapy in people with Flexible Flatfoot and Knee Pain, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lee eungjoon (+8201028850431, dmdwns777@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Muscle Tension from Baseline to 4 Weeks (Measured by Myoton Pro - Frequency in Hz) (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.