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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06861322
• Lead Sponsor: Sahmyook University

Brief 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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study Start: 2025-03-02
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Knee Muscle Tension from Baseline to 4 Weeks (Measured by Myoton Pro - Frequency in Hz)	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)	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)	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 Outcome Measures

Name	Time	Method
Change in Dynamic Balance from Baseline to 4 Weeks (Measured by Y-Balance Test - Reach Distance in cm)	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.
Change in Quality of Life from Baseline to 4 Weeks (Measured by EQ-5D-5L - Score on a 5-Dimension Scale)	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.
Change in Knee Pain from Baseline to 4 Weeks (Measured by WOMAC Pain Subscale - Score on a 5-Point Likert Scale)	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).
Change in Knee Function from Baseline to 4 Weeks (Measured by WOMAC Function Subscale - Score on a 5-Point Likert Scale)	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).

Trial Locations

Locations (1)

Samyuk University; 🇰🇷 Seoul, Nowon-gu, Korea, Republic of