The Effect of Lateral Wedge Insoles on Lower Limb Biomechanics, Muscle Activity and Knee Adduction Moment During Walking and Running

NCT07639411 | Not Yet Recruiting DMC

• 2 other identifiers: AnkaraYBU2026-1/10TDK-2026-2976
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this prospective, randomized, single-group interventional study is to use quantitative methods to investigate the acute effects of using lateral-wedge insoles on lower extremity biomechanics, muscle activation patterns, and knee adduction moment during walking and running activities in healthy individuals aged 18-40. The primary research questions it seeks to answer are as follows:

• Do lateral wedge insoles cause a significant change in knee adduction moment?
• Do lateral wedge insoles change lower extremity biomechanics during walking and running?
• Do lateral wedge insoles change the activation patterns of lower extremity muscles during walking and running? To compare the effectiveness of lateral wedge insoles, participants will randomly use insoles with 0 (neutral), 5, and 10-degree angles. Participants will do the following:
• Put on the shoes and insoles provided to you in the motion analysis laboratory and complete the walking and running protocols, each taking 1 minute, on the treadmill.
• While walking at your normal walking speed, step so that your dominant leg is positioned over the force plate.
• Repeat all of this for the insoles at the other two angles.

Conditions

Biomechanical Changes; Gait Biomechanics; Gait Analysis in Healthy Subjects; Running Kinematics; EMG

Keywords

Lateral Wedges İnsoles; Knee Adduction Moment; Gait Analysis; Running Analysis; EMG Activity

Outcome Measures

Primary Outcomes (1)

• Peak External Knee Adduction Moment (Peak KAM)

  The peak external knee adduction moment in the frontal plane will be calculated during walking. Kinematic data will be captured using a 3D motion analysis system, and kinetic data will be obtained via integrated force plates. The peak value will be extracted using inverse dynamics software. Unit of Measure: Nm/kg.

  İmmediately after the intervention (In every insole intervention)

Secondary Outcomes (2)

• Lower Extremity Joint Kinematics

  İmmediately after the intervention (In every insole intervention)

• Muscle Activation

  İmmediately after the intervention (In every insole intervention)

Study Arms (3)

Control: Neutral Insole (0°)

PLACEBO COMPARATOR

Participants will wear a flat, neutral insole with 0 degrees of inclination inside a standardized shoe. This arm serves as the baseline/control condition to measure natural gait and running biomechanics without any lateral wedging.

Device: 3D Movement Analysis; Device: Force Plate; Device: Electromyography (EMG)

5-Degree Lateral Wedge Insole

EXPERIMENTAL

Participants will wear a 5-degree lateral wedge insole placed inside a standardized shoe. The wedge is designed to provide a lateral tilt to the rearfoot. During gait and running, kinematic, kinetic, and EMG data will be collected to assess the biomechanical changes compared to the neutral condition.

Device: 3D Movement Analysis; Device: Force Plate; Device: Electromyography (EMG)

10-Degree Lateral Wedge Insole

EXPERIMENTAL

Participants will wear a 10-degree lateral wedge insole placed inside a standardized shoe. This arm aims to evaluate the effects of a higher degree of lateral inclination on lower extremity joint loading and muscle activation patterns during walking and running.

Device: 3D Movement Analysis; Device: Force Plate; Device: Electromyography (EMG)

Interventions

3D Movement Analysis DEVICE

Qualysis optoelectronic motion capture system (Gothenburg, Sweden) with 8 high-speed cameras will be used to record kinematic data at 2000 Hz. 32 reflective markers will be placed on anatomical landmarks. For the walking test, the participant will be asked to walk on a treadmill at a speed of 4 km/h on a 0° incline for 1 minute. For the running test, the participant will be asked to run at a speed of 8 km/h on a 0° incline for 1 minute. During walk and run, the following parameters will be measured and recorded using this gait analysis system: changes in tibial rotation, the degree of anterior-posterior and lateral pelvic tilt, pelvic height, pelvic rotation, changes in range of motion at the knee, hip, and ankle joints, and changes in the dynamic Q angle.

Also known as: insole, lateral wedge, biomechanics

10-Degree Lateral Wedge Insole; 5-Degree Lateral Wedge Insole; Control: Neutral Insole (0°)

Electromyography (EMG) DEVICE

The study will evaluate how EMG values change during walking and running protocols when the participant uses insoles. The Noraxon Ultium EMG (Noraxon, USA) device will be used for this purpose. The selection, localization, and application method of the electrodes to be used in surface EMG will be carried out in accordance with the recommendations of the Surface EMG for Non-invasive Muscle Assessment (SENIAM) guidelines. For EMG, wireless surface electrodes will be placed on the semimembranosus, biceps femoris, rectus femoris, lateral head of the gastrocnemius, soleus, tibialis anterior, erector spinae, and multifidus muscles at the L5 level on the dominant side. Participants will be fitted with 1 cm wide Ag/AgCl EMG/ECG electrodes. The activation values of these muscles will be recorded as mV values using the SEMG method.

Also known as: EMG

10-Degree Lateral Wedge Insole; 5-Degree Lateral Wedge Insole; Control: Neutral Insole (0°)

Force Plate DEVICE

An integrated force plate device (BERTEC FP4060, ABD) will be used to measure ground reaction forces (GRF) at 1200Hz to calculate joint moments through inverse dynamics. The knee adduction moment will be calculated in Newton-meters (Nm) as the product of the GRF's horizontal force and the length of the moment arm. The highest value of the knee adduction moment during walking will be recorded as the 'peak knee adduction moment' (pKAM).

Also known as: knee moments, adduksiyon moment

10-Degree Lateral Wedge Insole; 5-Degree Lateral Wedge Insole; Control: Neutral Insole (0°)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being able to walk and run 10 meters without assistance
• Not having sustained any injury to the lower extremities, pelvis, or trunk within the past 12 months
• Not having received any treatment for the lower extremities, pelvis, or trunk within the past 6 months
• Shoe size must be between EU 36 (22 cm) and EU 45 (28 cm) according to European Union (EU) standards
• Must have scored between 0 and +5 on the Foot Posture Index scale for both feet
• Have scored between 0 and 20 on the Revised Foot Function Index questionnaire
• Have a body mass index (BMI) between 18 and 25 kg/m²

You may not qualify if:

• Having cognitive impairment, vision or hearing problems, or a systemic disease that could affect overall health
• Having deformities, contractures, or any other abnormalities in the trunk or lower extremities that could affect participation
• Having a diagnosed foot or ankle deformity (e.g., pes planus, pes cavus, hallux valgus, etc.)
• Having any neurological or muscular disorder
• Being an active professional athlete
• Failure to sign the informed consent form

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (2)

Laboratories of the Center for Applied Sports Sciences and Research

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Laboratories of the Center for Applied Sports Sciences and Research

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (8)

• Yagci G, Erel S, Okunakol V. Validation of the Turkish version of the Revised Foot Function Index for patients with foot and ankle disorders. Foot Ankle Surg. 2020 Aug;26(6):624-629. doi: 10.1016/j.fas.2019.08.002. Epub 2019 Aug 12.

  PMID: 31431327 BACKGROUND

• Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.

  PMID: 16182419 BACKGROUND

• Brandon SCE, Brown MJ, Clouthier AL, Campbell A, Richards JD, Deluzio KJ. Contributions of muscles and external forces to medial knee load reduction due to osteoarthritis braces. Knee. 2019 Jun;26(3):564-577. doi: 10.1016/j.knee.2019.04.006. Epub 2019 May 14.

  PMID: 31097362 BACKGROUND

• Souza TR, Pinto RZ, Trede RG, Kirkwood RN, Pertence AE, Fonseca ST. Late rearfoot eversion and lower-limb internal rotation caused by changes in the interaction between forefoot and support surface. J Am Podiatr Med Assoc. 2009 Nov-Dec;99(6):503-11. doi: 10.7547/0990503.

  PMID: 19917736 BACKGROUND

• Edo M, Nishizawa G, Matsumura Y, Nemoto N, Yotsumoto N, Kojima S. The Relationship Between the Effects of Lateral Wedge Insoles and Kinematic Chain Dynamics Between the Hindfoot and Lower Leg in Patients With Osteoarthritis of the Knee. Cureus. 2023 Apr 15;15(4):e37624. doi: 10.7759/cureus.37624. eCollection 2023 Apr.

  PMID: 37200635 BACKGROUND

• Ulrich B, Hoffmann L, Jolles BM, Favre J. Changes in ambulatory knee adduction moment with lateral wedge insoles differ with respect to the natural foot progression angle. J Biomech. 2020 Apr 16;103:109655. doi: 10.1016/j.jbiomech.2020.109655. Epub 2020 Jan 24.

  PMID: 32057444 BACKGROUND

• Cain LE, Nicholson LL, Adams RD, Burns J. Foot morphology and foot/ankle injury in indoor football. J Sci Med Sport. 2007 Oct;10(5):311-9. doi: 10.1016/j.jsams.2006.07.012. Epub 2006 Sep 1.

  PMID: 16949867 BACKGROUND

• Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.

  PMID: 23369667 BACKGROUND

MeSH Terms

Interventions

Foot Orthoses; Electromyography

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Bahar Anaforoğlu, Professor

  Ankara Yildirim Beyazıt University

  STUDY DIRECTOR

• Enes Öztürk

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enes Öztürk

CONTACT

+905319695922; oztrk.enes@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participant nor the researcher performing the measurement will know which insole is being measured.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)