🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Turkey / NCT07639411
Starting soon Not applicable

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

NCT07639411 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-06
Last updated
2026-06-10

Condition(s) studied

Biomechanical ChangesGait BiomechanicsGait Analysis in Healthy SubjectsRunning KinematicsEMG

Investigational drug(s) / intervention(s)

3D Movement AnalysisForce PlateElectromyography (EMG)

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.

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).

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Laboratories of the Center for Applied Sports Sciences and Research Erzurum Yakutiye
Laboratories of the Center for Applied Sports Sciences and Research Erzurum Yakutiye

More Ankara Yildirim Beyazıt University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07639411 on ClinicalTrials.gov ↗ ← All trials in Turkey