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

6. Juni 2026 aktualisiert von: Bahar Anaforoglu, Ankara Yildirim Beyazıt University

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Lower extremity biomechanics plays a significant role in the balance of joint loads and muscle activation patterns during walking. Lateral wedge insoles are an orthotic intervention designed to both correct foot-ankle alignment and alter load distribution in the frontal plane at the knee joint. However, findings regarding the effects of these insoles on lower extremity kinematics, kinetics, and muscle activation patterns in healthy individuals are limited.

The aim of this study is to investigate the acute effects of using lateral wedge insoles on knee adduction moment, lower extremity biomechanics, and muscle activation levels in healthy individuals. The study will utilize a three-dimensional motion analysis system, a force platform, and surface electromyography (EMG). Participants will undergo walking and running tests under three different conditions in a randomized order: a 0° neutral insole, a 5° inclined lateral wedge insole, and a 10° inclined lateral wedge insole.

The data obtained aim to elucidate changes in mechanical loading and muscle activation associated with lateral wedge insoles, thereby strengthening the biomechanical foundations of design principles in insole prescription. Additionally, the reference data obtained from healthy individuals may provide a scientific basis for personalized insole design and rehabilitation protocols applicable to conditions such as knee osteoarthritis in future stages.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Yakutiye
      • Erzurum, Yakutiye, Türkei (türkiye), 25100
        • Laboratories of the Center for Applied Sports Sciences and Research
        • Kontakt:
        • Hauptermittler:
          • Enes Öztürk

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Control: Neutral Insole (0°)
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.
Gerät: 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.

Andere Namen:
  • insole
  • lateral wedge
  • biomechanics
Gerät: 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).

Andere Namen:
  • knee moments
  • adduksiyon moment
Gerät: 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.
Andere Namen:
  • EMG
Experimental: 5-Degree Lateral Wedge Insole
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.
Gerät: 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.

Andere Namen:
  • insole
  • lateral wedge
  • biomechanics
Gerät: 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).

Andere Namen:
  • knee moments
  • adduksiyon moment
Gerät: 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.
Andere Namen:
  • EMG
Experimental: 10-Degree Lateral Wedge Insole
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.
Gerät: 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.

Andere Namen:
  • insole
  • lateral wedge
  • biomechanics
Gerät: 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).

Andere Namen:
  • knee moments
  • adduksiyon moment
Gerät: 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.
Andere Namen:
  • EMG

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peak External Knee Adduction Moment (Peak KAM)
Zeitfenster: İmmediately after the intervention (In every insole intervention)

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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Lower Extremity Joint Kinematics
Zeitfenster: İmmediately after the intervention (In every insole intervention)
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.
İmmediately after the intervention (In every insole intervention)
Muscle Activation
Zeitfenster: İmmediately after the intervention (In every insole intervention)

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.
İmmediately after the intervention (In every insole intervention)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ankara Yildirim Beyazıt University

Ermittler

  • Studienleiter: Bahar Anaforoğlu, Professor, Ankara Yildirim Beyazıt University
  • Hauptermittler: Enes Öztürk, Ankara Yildirim Beyazıt University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AnkaraYBU2026-1/10
  • TDK-2026-2976 (Andere Kennung: Ankara Yıldırım Beyazıt Üniversitesi Bilimsel Araştırma Projeleri Koordinasyon Birimi)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

To protect participant privacy and in accordance with corporate data management policies and the sponsor approval process, participants' personal data relating to biomechanical laboratory datasets will not be shared outside the main research group.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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