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

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

Interventions

DEVICE

3D Movement Analysis

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.

DEVICE

Force Plate

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).

DEVICE

Electromyography (EMG)

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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University

  lead OTHER

Principal Investigators

• Bahar Anaforoğlu, Professor · Ankara Yildirim Beyazıt University

• Enes Öztürk · Ankara Yildirim Beyazıt University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Turkey (Türkiye)

Study Locations