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

February 28, 2025 updated by: EUNGJOON LEE, Sahmyook University

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

  • 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.
  • 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.
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.

  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
  • 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.
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
  • 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.
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
  • 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).
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
  • 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).
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: eungjoon lee, Samyuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2025

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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