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

NCT06861322 | Not Yet Recruiting

• 1 other identifier: SYU 2025-01-016-003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  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)

  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)

  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)

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

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.

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.

Behavioral: Conventional Physical Therapy

Interventions

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.

Short Foot Exercise + Conventional Physical Therapy

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.

Conventional Physical Therapy; Short Foot Exercise + Conventional Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Samyuk University

Seoul, Nowon-gu, 01795, South Korea

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• eungjoon lee

  Samyuk University

  STUDY DIRECTOR

Central Study Contacts

lee eungjoon

CONTACT

+8201028850431; dmdwns777@naver.com

lee Seungwon

CONTACT

+8201062492135; swlee@syu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: March 2, 2025
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)