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

2026년 6월 6일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Yakutiye
      • Erzurum, Yakutiye, 터키 (Türkiye), 25100
        • Laboratories of the Center for Applied Sports Sciences and Research
        • 연락하다:
        • 수석 연구원:
          • Enes Öztürk

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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.

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.

다른 이름들:
  • insole
  • lateral wedge
  • biomechanics

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).

다른 이름들:
  • knee moments
  • adduksiyon moment
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.
다른 이름들:
  • EMG
실험적: 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.

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.

다른 이름들:
  • insole
  • lateral wedge
  • biomechanics

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).

다른 이름들:
  • knee moments
  • adduksiyon moment
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.
다른 이름들:
  • EMG
실험적: 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.

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.

다른 이름들:
  • insole
  • lateral wedge
  • biomechanics

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).

다른 이름들:
  • knee moments
  • adduksiyon moment
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.
다른 이름들:
  • EMG

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Peak External Knee Adduction Moment (Peak KAM)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Lower Extremity Joint Kinematics
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Bahar Anaforoğlu, Professor, Ankara Yildirim Beyazıt University
  • 수석 연구원: Enes Öztürk, Ankara Yildirim Beyazıt University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 6일

QC 기준을 충족하는 최초 제출

2026년 6월 6일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 6일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다