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NCT Number: NCT06861322

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

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.

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Key information

Conditions

Flexible Flatfoot Balance Impairment Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Knee Pain Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Quality of Life (QOL) Talipes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short Foot Exercise

Behavioral
  • 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 Therapy

Behavioral
  • 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

lee Seungwon

CONTACT

[email protected]

+8201062492135

lee eungjoon

CONTACT

[email protected]

+8201028850431

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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