The Effect of Lateral Wedge Insoles on Lower Limb Biomechanics, Muscle Activity and Knee Adduction Moment During Walking and Running
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Enes Öztürk
- 電話番号：+905319695922
- メール：oztrk.enes@outlook.com
研究場所
-
-
Yakutiye
-
Erzurum、Yakutiye、トルコ（Türkiye）、25100
- Laboratories of the Center for Applied Sports Sciences and Research
-
コンタクト：
- Hasan H Yılmaz, Associate Professor
- 電話番号：+905058086471
- メール：hasanh.yilmaz@atauni.edu.tr
-
主任研究者：
- Enes Öztürk
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：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.
他の名前：
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).
他の名前：
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.
他の名前：
|
|
実験的：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.
他の名前：
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).
他の名前：
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.
他の名前：
|
|
実験的：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.
他の名前：
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).
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Peak External Knee Adduction Moment (Peak KAM)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lower Extremity Joint Kinematics
時間枠：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
時間枠：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)
|
協力者と研究者
捜査官
- スタディディレクター：Bahar Anaforoğlu, Professor、Ankara Yildirim Beyazıt University
- 主任研究者：Enes Öztürk、Ankara Yildirim Beyazıt University
出版物と役立つリンク
一般刊行物
- Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.
- Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.
- Yagci G, Erel S, Okunakol V. Validation of the Turkish version of the Revised Foot Function Index for patients with foot and ankle disorders. Foot Ankle Surg. 2020 Aug;26(6):624-629. doi: 10.1016/j.fas.2019.08.002. Epub 2019 Aug 12.
- Brandon SCE, Brown MJ, Clouthier AL, Campbell A, Richards JD, Deluzio KJ. Contributions of muscles and external forces to medial knee load reduction due to osteoarthritis braces. Knee. 2019 Jun;26(3):564-577. doi: 10.1016/j.knee.2019.04.006. Epub 2019 May 14.
- Souza TR, Pinto RZ, Trede RG, Kirkwood RN, Pertence AE, Fonseca ST. Late rearfoot eversion and lower-limb internal rotation caused by changes in the interaction between forefoot and support surface. J Am Podiatr Med Assoc. 2009 Nov-Dec;99(6):503-11. doi: 10.7547/0990503.
- Edo M, Nishizawa G, Matsumura Y, Nemoto N, Yotsumoto N, Kojima S. The Relationship Between the Effects of Lateral Wedge Insoles and Kinematic Chain Dynamics Between the Hindfoot and Lower Leg in Patients With Osteoarthritis of the Knee. Cureus. 2023 Apr 15;15(4):e37624. doi: 10.7759/cureus.37624. eCollection 2023 Apr.
- Ulrich B, Hoffmann L, Jolles BM, Favre J. Changes in ambulatory knee adduction moment with lateral wedge insoles differ with respect to the natural foot progression angle. J Biomech. 2020 Apr 16;103:109655. doi: 10.1016/j.jbiomech.2020.109655. Epub 2020 Jan 24.
- Cain LE, Nicholson LL, Adams RD, Burns J. Foot morphology and foot/ankle injury in indoor football. J Sci Med Sport. 2007 Oct;10(5):311-9. doi: 10.1016/j.jsams.2006.07.012. Epub 2006 Sep 1.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- AnkaraYBU2026-1/10
- TDK-2026-2976 (その他の識別子：Ankara Yıldırım Beyazıt Üniversitesi Bilimsel Araştırma Projeleri Koordinasyon Birimi)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。