ClinicalTrials.gg
Not yet recruitingNCT06861322Updated Mar 6, 2025

Effects of Short Foot Exercise on Knee Pain, Muscle Tone, Balance, and Quality of Life in Flexible Flatfoot Patients

An interventional study of Short Foot Exercise and Conventional Physical Therapy in Flexible Flatfoot, Knee Pain and Balance Impairment, sponsored by Sahmyook University. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by Sahmyook University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Flexible Flatfoot
  • Knee Pain
  • Balance Impairment
  • Quality of Life (QOL)

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03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 44 is close to the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Sahmyook University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Short Foot Exercise + Conventional Physical Therapy

    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.

    Behavioral: Short Foot Exercise · Behavioral: Conventional Physical Therapy

  • Active comparator
    Conventional Physical Therapy

    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.

    Behavioral: Conventional Physical Therapy

Interventions

  • BehavioralShort 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.

  • BehavioralConventional 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 4 weeks

  3. 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.

    Time frame: From enrollment to the end of treatment at 4 weeks

Secondary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 4 weeks

  3. 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).

    Time frame: From enrollment to the end of treatment at 4 weeks

  4. 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).

    Time frame: From enrollment to the end of treatment at 4 weeks

07

Study locations

1 site
  • Samyuk University
    Seoul, Nowon-gu 01795, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2025; primary completion for Apr 2025, 1 month later.

Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 1 month is below that.

Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2025
First posted
Mar 6, 2025
StartEst.
Mar 2, 2025
Primary completionEst.
Apr 30, 2025
CompletionEst.
Jun 30, 2025
Last update
Mar 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06861322
Lead sponsor
Sahmyook University
Responsible party
EUNGJOON LEE (Principal investigator, Sahmyook University) — Principal investigator
First posted
Mar 6, 2025
Start date
Mar 2, 2025 (estimated)
Primary completion
Apr 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 6, 2025

Study contacts

lee eungjoon
Contact
dmdwns777@naver.com
+8201028850431
lee Seungwon
Contact
swlee@syu.ac.kr
+8201062492135
eungjoon lee
study director · Samyuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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