The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance

NCT ID: NCT06300671

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The lower extremity consists of segments that can be affected by the relative position of each other. Deviation of one segment from its normal alignment in the lower extremity also affects the alignment of other segments. The hip joint can affect the frontal plane alignment from proximal to distal, while the foot and ankle complex can also affect it from distal to proximal. Increased subtalar joint pronation in the kinetic chain from distal to proximal; is associated with decreased dorsiflexion angle and increased frontal plane projection angle. It has been shown that ankle dorsiflexion limitation causes changes in the biomechanics and kinematics of landing after jumping, but no study examining the effect of foot pronation on jump tests has been found in the literature. Since the foot is located at the most distal point and acts as a support base for the kinematic chain, the smallest dynamic change in the foot affects the balance of the whole body. Due to foot pronation, changes in the sole contact surface may make it difficult for the foot to adapt to the ground, balance and postural stabilization may be adversely affected, and an increase in the workload of the muscles around the joint may be observed. In another study, it is mentioned that there is limited evidence about the effect of foot posture on postural stability. Although there are studies in the literature examining the effects of subtalar joint pronation on lower extremity alignment and postural stability, studies need to examine the effects of different subtalar joint pronation amounts on lower extremity alignment, jumping performance, and postural stability. Our study will contribute to the literature with this aspect.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The foot has an important role as it supports body weight and plays a vital role during movement. The ankle complex consists of the talocrural and subtalar joints, which have diagonal axes that perform multi-planar movements. Because of its oblique axis, the subtalar joint can produce three-planar movements, pronation, and supination. Foot pronation consists of medial rotation and adduction of the talus, eversion of the calcaneus, and abduction and supination of the forefoot. Medial longitudinal arch height decreased or disappeared in feet in pronation posture. Loss of medial longitudinal arch height requires that the foot cannot absorb enough energy and must produce more force to stabilize it. In particular, abnormal alignment in the hyper pronation posture or prolonged pronation is defined as both a risk factor and an etiologic factor for increased navicular drop and malalignment patterns in the lower extremities. It is a possible etiologic cause for the development of most lower extremity overuse injuries by altering kinematics and force distribution. The lower extremity consists of segments that can be affected by the relative position of each other. Deviation of one segment from its normal alignment in the lower extremity also affects the alignment of other segments. In the frontal plane alignment, the hip joint can be affected from proximal to distal, while the foot and ankle complex can be affected from distal to proximal. Increased subtalar joint pronation in the kinetic chain from distal to proximal is associated with decreased dorsiflexion angle and increased frontal plane projection angle. It has been shown that ankle dorsiflexion limitation causes changes in the biomechanics and kinematics of landing after jumping, but no study examining the effect of foot pronation on jump tests has been found in the literature.

Since the foot is located at the most distal point and acts as a support base for the kinematic chain, the smallest dynamic change in the foot affects the balance of the whole body. Due to foot pronation, changes in the sole contact surface may make it difficult for the foot to adapt to the ground, balance and postural stabilization may be adversely affected, and an increase in the workload of the muscles around the joint may be observed. It is mentioned that there is limited evidence about the effect of foot posture on postural stability. there is a need for studies examining the effects of different subtalar joint pronation amounts on lower extremity alignment, jumping performance, and postural stability. Our study will contribute to the literature with this aspect.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Balance Disorders Foot Injury Lower Extremity Problem

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

48 healthy individuals between the ages of 18-40 constitute the population of the study. Participants randomized into neutral, pronation, and hyperpronation groups.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pronation Group

Participants with a value between 6-9 according to the foot posture index-6 evaluation will be included in the pronation group.

Group Type ACTIVE_COMPARATOR

Foot Posture Index-6

Intervention Type OTHER

Foot Posture Index 6 (API-6) is a clinical diagnostic tool that broadly measures whether a foot is in neutral, supination or pronation posture. During the evaluation, individuals' static standing postures in a comfortable position are observed and scored. When using API-6, researchers visually evaluate the foot according to 6 criteria, each rated on a 5-point (-2 to +2) Likert scale. Each item is scored between -2 (supination) and +2 (pronation) and 0 (for neutral position), with the total score being between -12 (high degree of supination) and +12 (high degree of pronation). The grouping of reference values showing foot posture can be summarized as follows; Neutral position from 0 to +5, pronation position from +6 to +9, hyperpronation position from +10 to +12, supination position from -1 to -5, and supination position from -6. It shows a high degree of supination position up to -12. Higher scores represent a more pronated foot posture.

Hyperpronation Group

Participants with a value between 10-12 according to the foot posture index-6 evaluation will be included in the hyperpronation group.

Group Type ACTIVE_COMPARATOR

Foot Posture Index-6

Intervention Type OTHER

Foot Posture Index 6 (API-6) is a clinical diagnostic tool that broadly measures whether a foot is in neutral, supination or pronation posture. During the evaluation, individuals' static standing postures in a comfortable position are observed and scored. When using API-6, researchers visually evaluate the foot according to 6 criteria, each rated on a 5-point (-2 to +2) Likert scale. Each item is scored between -2 (supination) and +2 (pronation) and 0 (for neutral position), with the total score being between -12 (high degree of supination) and +12 (high degree of pronation). The grouping of reference values showing foot posture can be summarized as follows; Neutral position from 0 to +5, pronation position from +6 to +9, hyperpronation position from +10 to +12, supination position from -1 to -5, and supination position from -6. It shows a high degree of supination position up to -12. Higher scores represent a more pronated foot posture.

Neutral Group

Participants with a value between 0-5 according to the foot posture index-6 evaluation will be included in the neutral group.

Group Type ACTIVE_COMPARATOR

Foot Posture Index-6

Intervention Type OTHER

Foot Posture Index 6 (API-6) is a clinical diagnostic tool that broadly measures whether a foot is in neutral, supination or pronation posture. During the evaluation, individuals' static standing postures in a comfortable position are observed and scored. When using API-6, researchers visually evaluate the foot according to 6 criteria, each rated on a 5-point (-2 to +2) Likert scale. Each item is scored between -2 (supination) and +2 (pronation) and 0 (for neutral position), with the total score being between -12 (high degree of supination) and +12 (high degree of pronation). The grouping of reference values showing foot posture can be summarized as follows; Neutral position from 0 to +5, pronation position from +6 to +9, hyperpronation position from +10 to +12, supination position from -1 to -5, and supination position from -6. It shows a high degree of supination position up to -12. Higher scores represent a more pronated foot posture.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Foot Posture Index-6

Foot Posture Index 6 (API-6) is a clinical diagnostic tool that broadly measures whether a foot is in neutral, supination or pronation posture. During the evaluation, individuals' static standing postures in a comfortable position are observed and scored. When using API-6, researchers visually evaluate the foot according to 6 criteria, each rated on a 5-point (-2 to +2) Likert scale. Each item is scored between -2 (supination) and +2 (pronation) and 0 (for neutral position), with the total score being between -12 (high degree of supination) and +12 (high degree of pronation). The grouping of reference values showing foot posture can be summarized as follows; Neutral position from 0 to +5, pronation position from +6 to +9, hyperpronation position from +10 to +12, supination position from -1 to -5, and supination position from -6. It shows a high degree of supination position up to -12. Higher scores represent a more pronated foot posture.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Postural stability Assessment Frontal Plane Projection Angle Foot and Ankle Ability Measurement Navicular Drop test Weight bearing lunge test Counter movement jump test without arm swing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Being between the ages of 18-40

* Pain, difficulty in walking and loss of function, etc. not having complaints
* Foot posture index value should be between 6-12
* Not having any orthopedic disease
* Not having visual or hearing impairment
* Not having been involved in any physical therapy program in the last 6 months.
* Not having undergone any surgical procedure on the lower extremity
* Not using analgesic medication within the specified treatment days throughout the research period.

Exclusion Criteria

* Having a lower extremity congenital anomaly
* Having a history of lower extremity surgery or planned lower extremity surgery within the next 12 months
* Having any signs of pain in the lower extremities
* Having ligament hyperlaxity
* Having a history of tendon or cartilage injury
* Having serious illnesses
* Predominant knee pain from other knee structures, hip or lumbar spine
* Having a history of using any shoe insert-orthosis-insoles or knee injection in the last 3 months
* Having any neurological or systemic inflammatory arthritis disorder (neurological involvement that affects movement)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pelin Pişirici

Assistant Professor, PT, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pelin Pişirici, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Bahcesehir University, Faculty of Health Sciences

Ozlem Feyzioğlu, PT, PhD

Role: STUDY_CHAIR

Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences

Nurefşan Kaygaz, PT

Role: STUDY_CHAIR

Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation

Yahya Süleyman Mollaibrahimoğlu, PT

Role: STUDY_CHAIR

Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bahcesehir University

Beşiktaş, Istanbul, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PNSÖ-Subtalar pronation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurocognitive Exercises for Ankle Instability
NCT06567847 NOT_YET_RECRUITING NA