Biomechanical ChangesNCT07639411
The Effect of Lateral Wedge Insoles on Lower Limb Biomechanics, Muscle Activity and Knee Adduction Moment During Walking and Running
A study testing 3D Movement Analysis, Force Plate and Electromyography (EMG) in people with Biomechanical Changes and Gait Biomechanics, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomechanical Changes, Gait Biomechanics, Gait Analysis in Healthy Subjects
- What is being tested?
- 3D Movement Analysis, Force Plate and Electromyography (EMG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Laboratories of the Center for Applied Sports Sciences and Research
Erzurum, Yakutiye, 25100
Hasan H Yılmaz, Associate Professor, +905058086471, hasanh.yilmaz@atauni.edu.tr
Enes Öztürk
Laboratories of the Center for Applied Sports Sciences and Research
Erzurum, Yakutiye, 25100
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Biomechanical Changes, Gait Biomechanics, Gait Analysis in Healthy Subjects, Running Kinematics, EMG
- Being tested
- 3D Movement Analysis, Force Plate, Electromyography (EMG)
- Keywords
- Lateral Wedges İnsoles, Knee Adduction Moment, Gait Analysis, Running Analysis, EMG Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Movement AnalysisDevice
Also called insole, lateral wedge, biomechanics
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 PlateDevice
Also called knee moments, adduksiyon moment
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
Also called 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 group | Role | What they receive |
|---|---|---|
| Control: Neutral Insole (0°) | Placebo comparator | 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. Receives: Device: 3D Movement Analysis; Device: Force Plate; Device: Electromyography (EMG) |
| 5-Degree Lateral Wedge Insole | Experimental | 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. Receives: Device: 3D Movement Analysis; Device: Force Plate; Device: Electromyography (EMG) |
| 10-Degree Lateral Wedge Insole | Experimental | 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. Receives: Device: 3D Movement Analysis; Device: Force Plate; Device: Electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: İmmediately after the intervention (In every insole intervention)
Secondary outcomes (2)
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.
Measured: İmmediately after the intervention (In every insole intervention)
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.
Measured: İmmediately after the intervention (In every insole intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Biomechanical ChangesStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Anaforoglu, Ankara Yildirim Beyazıt University
- Investigators
- Bahar Anaforoğlu, Professor, Study director, Ankara Yildirim Beyazıt UniversityEnes Öztürk, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639411
- Sponsor's protocol ID
- AnkaraYBU2026-1/10
- Other IDs
- TDK-2026-2976
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31431327Redmond 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.
PubMed 16182419Brandon 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.
PubMed 31097362Souza 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.
PubMed 19917736Edo 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.
PubMed 37200635Ulrich 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.
PubMed 32057444Cain 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.
PubMed 16949867Budiman-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.
PubMed 23369667
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lateral Wedge Insoles on Lower Limb Biomechanics, Muscle Activity and Knee Adduction Moment During Walking and Running
- ClinicalTrials.gov ID
- NCT07639411
- Acronym / sponsor ID
- AnkaraYBU2026-1/10
- Conditions
- Biomechanical Changes, Gait Biomechanics, Gait Analysis in Healthy Subjects, Running Kinematics, EMG
- Keywords
- Lateral Wedges İnsoles, Knee Adduction Moment, Gait Analysis, Running Analysis, EMG Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control: Neutral Insole (0°) | Placebo comparator | Device: 3D Movement Analysis, Device: Force Plate, Device: Electromyography (EMG)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. |
| 5-Degree Lateral Wedge Insole | Experimental | Device: 3D Movement Analysis, Device: Force Plate, Device: Electromyography (EMG)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. |
| 10-Degree Lateral Wedge Insole | Experimental | Device: 3D Movement Analysis, Device: Force Plate, Device: Electromyography (EMG)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Failure to sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Movement AnalysisAlso: insole, lateral wedge, biomechanicsQualysis 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. | Device | 10-Degree Lateral Wedge Insole, 5-Degree Lateral Wedge Insole, Control: Neutral Insole (0°) |
| Force PlateAlso: knee moments, adduksiyon momentAn 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). | Device | 10-Degree Lateral Wedge Insole, 5-Degree Lateral Wedge Insole, Control: Neutral Insole (0°) |
| Electromyography (EMG)Also: EMGThe 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. | Device | 10-Degree Lateral Wedge Insole, 5-Degree Lateral Wedge Insole, Control: Neutral Insole (0°) |
Primary outcome
Peak External Knee Adduction Moment (Peak KAM)
Time frame: 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.
2 secondary outcomes
Lower Extremity Joint Kinematics
Time frame: İmmediately after the intervention (In every insole intervention)
Muscle Activation
Time frame: İmmediately after the intervention (In every insole intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 31431327Yagci 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.
- Background: PubMed 16182419Redmond 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.
- Background: PubMed 31097362Brandon 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.
- Background: PubMed 19917736Souza 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.
- Background: PubMed 37200635Edo 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.
- Background: PubMed 32057444Ulrich 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.
- Background: PubMed 16949867Cain 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.
- Background: PubMed 23369667Budiman-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahar Anaforoğlu, Professor study director
Ankara Yildirim Beyazıt University
Enes Öztürk principal investigator
Ankara Yildirim Beyazıt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Movement Analysis, Force Plate and Electromyography (EMG) in people with Biomechanical Changes and Gait Biomechanics, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enes Öztürk (+905319695922, oztrk.enes@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak External Knee Adduction Moment (Peak KAM) (time frame: İmmediately after the intervention (In every insole intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07639411, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.