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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAnkara Yildirim Beyazıt University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 any neurological or muscular disorder

Being an active professional athlete

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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).

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Control: Neutral Insole (0°)Placebo comparator 3 interventions
Group B: 5-Degree Lateral Wedge InsoleExperimental treatment 3 interventions
Group C: 10-Degree Lateral Wedge InsoleExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
İmmediately after the intervention (In every insole intervention)

Secondary outcomes

1

Lower Extremity Joint Kinematics

Joint kinematics and surface electromyography (sEMG) will be recorded simultaneously to assess the dynamic changes during walking and running. A 3D motion analysis system will capture the peak angular displacements and total range of motion (ROM) of the ankle (e.g., inversion/eversion), knee (e.g., flexion/extension, varus/valgus, tibial rotation), hip joints ( e.g., internal/external rotation) and pelvic movements (e.g., pelvic tilt) in the sagittal, frontal, and transverse planes.

Time frame
İmmediately after the intervention (In every insole intervention)
2

Muscle Activation

In conjunction with joint kinematic measurements, a wireless sEMG system will be used to record peak muscle activation in the semimembranosus, biceps femoris, rectus femoris, lateral head of the gastrocnemius, soleus, tibialis anterior, erector spinae, and multifidus muscles (at the L5 level). Unit of Measure: Degrees for joint angles, and Percentage of MVIC (%MVIC) for muscle activation.

Time frame
İmmediately after the intervention (In every insole intervention)

Other outcomes

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