The Effect Subtalar Joint Pronation on Postural Stability and Lower Extremity Alignment

February 6, 2024 updated by: Pelin Pişirici, Bahçeşehir University

The Effect of Different Subtalar Joint Pronation Amounts on Postural Stability and Lower Extremity Alignment in Healthy Individuals

The lower extremity consists of sequent columns. The deviation of one segment from its normal alignment in the lower extremity also affects the alignment of the other segments. The alignment of the parts of the foot during weight bearing is called foot posture. Foot posture is divided into neutral, pronation, and supination. Foot posture varies significantly from person to person, and deviations from normal foot posture are associated with lower extremity injuries. Increased or prolonged pronation has been identified as both a risk factor and etiologic factor for increased navicular drop, a lower extremity malalignment pattern. In pronation posture, the foot may not adequately adapt to the ground, and there is increased movement of the lower extremity in the frontal plane. As a result, the person's postural stability is compromised. The fact that the foot is the most distal segment of the lower extremity chain indicates that even small biomechanical changes in the bearing surface can significantly affect postural control strategies. There are studies in the literature that examine the effect of foot pronation on dynamic balance and postural stability in individuals with different foot postures. However, to our knowledge, there is no study that examines differences in postural stabilization and lower extremity alignment by classifying individuals with varying degrees of subtalar joint pronation into pronation and hyper pronation groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Examination of the biomechanics of the foot and ankle is an important aspect in the evaluation of human movement. The purpose of this study is to divide healthy subjects into pronation and hyperpronation foot postures and investigate the effects of differences subtalar pronation amounts in lower extremity alignment and postural stabilization. The part of the foot where the subtalar joint is located is called the hindfoot. The anatomy and alignment of the hindfoot is a critical factor in the biomechanics of the lower extremities and the function of human locomotion. Pronation of the foot causes tibial internal rotation and femoral internal rotation through the mechanism of the kinetic chain, resulting in valgus alignment of the knee when the foot is on the ground. The valgus alignment changes the position of the pelvis. Alternations in pelvic position increases the tension on the hip and pelvic muscles because it changes the force lever. In addition, increased femoral internal rotation of the lower extremity relative to the tibia has been shown to increase stress on the weight-bearing tissues of the tibio-femoral compartments and increase tibial internal rotation in individuals with pronated foot posture. Normal pronation motion is necessary for proper foot function, but increased and excessive pronation of the subtalar joint is a condition that should be investigated because it presents several problems with lower extremity alignment. The fact that foot pronation is important for the lower extremity kinetic chain during dynamic tasks prompts us to investigate foot pronation by measuring it in various ways. The purpose of this study is to divide healthy subjects into pronators and hyper pronators and to investigate the effects of differences in lower extremity kinetic chain alignment and postural stabilization and in healthy subjects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Besiktas/Istanbul
      • İstanbul, Besiktas/Istanbul, Turkey, 34353
        • Pelin Pişirici

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between 18 and 40 years old
  • Not to have pain and function loss
  • Foot posture index value between 6-12
  • No orthopedic disease
  • Not be visually or hearing impaired
  • Not have participated in a physical therapy program in the past 6 months
  • Not have undergone any surgical procedure on the lower extremity
  • No intake of pain medication during the examination period and within the specified treatment days

Exclusion Criteria:

  • Having congenital anomaly of the lower extremity
  • Having a history of lower extremity surgery or lower extremity surgery planned within the next 12 months
  • Having ligament hyperlaxity
  • Having a history of tendon or cartilage injury
  • Having metabolic disease, cancer
  • Using any kind of support/orthosis in the shoe
  • Having knee injections in the past 3 months
  • Any neurological or systemic inflammatory arthritis disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pronation Group
Participants will be assessed using the foot posture index-6 (FPI-6), and those who exhibit pronation of the subtalar joint will be included in the study. Participants to be included in the study will be divided into two groups according to their values for pronation increase in the subtalar joint. Participants with a value between 6 and 9 according to FPI-6 will be included in pronation group.
Other: Postural stability assessment
The Biodex Balance System SD (BDS) (Biodex Medical Systems Inc., Shirley, New York, USA) assesses postural stability (PS). Both static PS (SPS) and dynamic PS (DPS) will be assessed. In the DPS assessment, the platform can be tilted 20° in any direction. For static measurement, participants will be asked to stand barefoot on the platform, stand on one leg, keep the knees in 20-30° flexion. Meanwhile the contralateral knee will be asked to keep in 90° flexion, and stabilize their feet until the end of the test. Upon completion of the SPS assessment, the DPS assessment will be performed. The difficulty level of the DPS test will accepted as 4. For both SPS and the DPS assessment, the test consists of 3 trials of 20 seconds each with a 10-second break between trials.
Other: Frontal plan prjection angle
Frontal Plan Projection Angle (FPPA) is calculated as the angle between the thigh segment and the trunk segment based on the postural image, considering the position of the thigh and tibia. The FPPA will be evaluated using the Spark motion Pro™ application (2D). Before measurement, markers will be placed bilaterally at the SIAS, at the midpoint of the femoral condyles, and at the midpoint of the ankle bones. Participants will stand on the floor barefoot and arms crossed over the chest. Subjects will be asked to squat in a controlled manner and perform a 60° knee bend without losing balance before returning to the starting position. Test will be performed by using single leg squat test. The one-legged squat will be performed for 5 seconds at a standard pace with the researcher acting as the counter. Degrees smaller than 165 will be accepted as increase in knee valgus.
Other: Foot and Ankle Ability Measure
The Foot and Ankle Ailability Measure (FAAM) is used to assess the self-reported overall functional level of patients with leg, foot, and ankle musculoskeletal injuries and conditions. It consists of 1) activities of daily living [ADL] and 2) sports [S] and can be scored from 0 to 100%. In the FAAM, there are 29 items that are scored from 0 to 4. There are 21 items related to various functional activities under the subtitle activities of daily living, and 8 items related to various activities related to participation in sports under the subtitle sports. Standardized response options are answered on five-point likert scales ranging from 0 (I cannot) to 4 (no difficulty). Point totals between 0 and 84 for the ADL subtitle and between 0 and 32 for the Sports subtitle are converted to percentage points.
Other: Navicular Drop Test
The navicular drop test (NDT) is a clinical method for assessing the mobility of the medial longitudinal arch (MLA). The extent of navicular subsidence is assessed to determine the flexibility of the MLA and the position of the navicular with and without transfer of body weight. To assess navicular drop, the subtalar joint will be positioned in neutral position and the height of the navicular will be measured in non-weight bearing position. Then the measurement will be repeated in weightbearing position. The height difference between the two measurements in sitting and standing is recorded as the NDT value. Values more than 10mm is accepted as pathological.
Other: Calcaneotibial Angle Measurement
Measurement of the calcaneotibial angle (CTA) is one of the methods used in the evaluation of the foot and ankle. By measuring this angle, it is assessed whether the ankle problems are related to the hindfoot. In the CTA measurement, the angle between the vertical axis of the calcaneus and the longitudinal axis of the achilles tendon is measured in the standing and prone positions, and the differences will be recorded. Values more than 8 degrees is accepted as calcaneal valgus.
Other: Tibial Torsion Angle
Tibial torsion is a rotational deformity which can be measured between the long axis of the tibia and the transmalleolar axes. This measurement can be used to determine the extent to foot malalignment is due to bone torsion. Measurement will be done by a goniometer. Participants will be asked to lie prone and will be positioned with the knee joint in 90° flexion and the ankle joint in a neutral position. Normal alignment is 20 degrees external rotation. Any increase or decrease accepted as pathological.
Other: Femoral internal and external rotation measurement
Accurate assessment of hip joint range of motion (ROM) is an important component in the overall clinical evaluation of lower extremity injuries, particularly those of the hip and groin. The expected hip rotational range of motion for internal rotation (IR) is 45°, and for external rotation (ER) is 0° to 45°. In this study, a smartphone-based inclinometer will be used to measure femoral IR and ER. The inclinometer will be placed vertically so that the top edge is just below the tibial tuberosity and the bottom edge is pointed at the midpoint of the medial and lateral malleoli.
Active Comparator: Hyper pronation group
Participants with a value between 10 and 12 according to FPI-6 will be included in hyper pronation group.
Other: Postural stability assessment
The Biodex Balance System SD (BDS) (Biodex Medical Systems Inc., Shirley, New York, USA) assesses postural stability (PS). Both static PS (SPS) and dynamic PS (DPS) will be assessed. In the DPS assessment, the platform can be tilted 20° in any direction. For static measurement, participants will be asked to stand barefoot on the platform, stand on one leg, keep the knees in 20-30° flexion. Meanwhile the contralateral knee will be asked to keep in 90° flexion, and stabilize their feet until the end of the test. Upon completion of the SPS assessment, the DPS assessment will be performed. The difficulty level of the DPS test will accepted as 4. For both SPS and the DPS assessment, the test consists of 3 trials of 20 seconds each with a 10-second break between trials.
Other: Frontal plan prjection angle
Frontal Plan Projection Angle (FPPA) is calculated as the angle between the thigh segment and the trunk segment based on the postural image, considering the position of the thigh and tibia. The FPPA will be evaluated using the Spark motion Pro™ application (2D). Before measurement, markers will be placed bilaterally at the SIAS, at the midpoint of the femoral condyles, and at the midpoint of the ankle bones. Participants will stand on the floor barefoot and arms crossed over the chest. Subjects will be asked to squat in a controlled manner and perform a 60° knee bend without losing balance before returning to the starting position. Test will be performed by using single leg squat test. The one-legged squat will be performed for 5 seconds at a standard pace with the researcher acting as the counter. Degrees smaller than 165 will be accepted as increase in knee valgus.
Other: Foot and Ankle Ability Measure
The Foot and Ankle Ailability Measure (FAAM) is used to assess the self-reported overall functional level of patients with leg, foot, and ankle musculoskeletal injuries and conditions. It consists of 1) activities of daily living [ADL] and 2) sports [S] and can be scored from 0 to 100%. In the FAAM, there are 29 items that are scored from 0 to 4. There are 21 items related to various functional activities under the subtitle activities of daily living, and 8 items related to various activities related to participation in sports under the subtitle sports. Standardized response options are answered on five-point likert scales ranging from 0 (I cannot) to 4 (no difficulty). Point totals between 0 and 84 for the ADL subtitle and between 0 and 32 for the Sports subtitle are converted to percentage points.
Other: Navicular Drop Test
The navicular drop test (NDT) is a clinical method for assessing the mobility of the medial longitudinal arch (MLA). The extent of navicular subsidence is assessed to determine the flexibility of the MLA and the position of the navicular with and without transfer of body weight. To assess navicular drop, the subtalar joint will be positioned in neutral position and the height of the navicular will be measured in non-weight bearing position. Then the measurement will be repeated in weightbearing position. The height difference between the two measurements in sitting and standing is recorded as the NDT value. Values more than 10mm is accepted as pathological.
Other: Calcaneotibial Angle Measurement
Measurement of the calcaneotibial angle (CTA) is one of the methods used in the evaluation of the foot and ankle. By measuring this angle, it is assessed whether the ankle problems are related to the hindfoot. In the CTA measurement, the angle between the vertical axis of the calcaneus and the longitudinal axis of the achilles tendon is measured in the standing and prone positions, and the differences will be recorded. Values more than 8 degrees is accepted as calcaneal valgus.
Other: Tibial Torsion Angle
Tibial torsion is a rotational deformity which can be measured between the long axis of the tibia and the transmalleolar axes. This measurement can be used to determine the extent to foot malalignment is due to bone torsion. Measurement will be done by a goniometer. Participants will be asked to lie prone and will be positioned with the knee joint in 90° flexion and the ankle joint in a neutral position. Normal alignment is 20 degrees external rotation. Any increase or decrease accepted as pathological.
Other: Femoral internal and external rotation measurement
Accurate assessment of hip joint range of motion (ROM) is an important component in the overall clinical evaluation of lower extremity injuries, particularly those of the hip and groin. The expected hip rotational range of motion for internal rotation (IR) is 45°, and for external rotation (ER) is 0° to 45°. In this study, a smartphone-based inclinometer will be used to measure femoral IR and ER. The inclinometer will be placed vertically so that the top edge is just below the tibial tuberosity and the bottom edge is pointed at the midpoint of the medial and lateral malleoli.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postural stability assessment
Time Frame: Baseline
The Biodex Balance System SD (BDS) (Biodex Medical Systems Inc., Shirley, New York, USA) assesses postural stability (PS). Both static PS (SPS) and dynamic PS (DPS) will be assessed on single leg. The investigators will assess postural stability only one time.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frontal plan prjection angle (FPPA)
Time Frame: Baseline
2D motion analysis data were evaluated with the Spark Motion Pro™ mobile motion analysis system during the one-leg squat test, a functional test for dynamic knee valgus. FPPAs were measured with the Spark Motion Pro™ goniometry application. The validity and the reliability study of the FPPA measurement in individuals with DDV was conducted by Ramirez et al. in 2018. The use of the application in individuals with DDV was found to be reliable. Degrees smaller than 165 will be accepted as increase in knee valgus. The investigators will assess FPPA only one time.
Baseline
Foot and Ankle Ability Measure (FAAM)
Time Frame: Baseline
FAAM is used to assess the self-reported overall functional level of patients with leg, foot, and ankle musculoskeletal injuries and conditions. It consists of 1) activities of daily living [ADL] and 2) sports [S] and can be scored from 0 to 100%. In the FAAM, there are 29 items that are scored from 0 to 4. There are 21 items related to various functional activities under the subtitle activities of daily living, and 8 items related to various activities related to participation in sports under the subtitle sports. Standardized response options are answered on five-point likert scales ranging from 0 (I cannot) to 4 (no difficulty). Point totals between 0 and 84 for the ADL subtitle and between 0 and 32 for the Sports subtitle are converted to percentage points. The investigators will assess FAAM only one time.
Baseline
Navicular Drop Test (NDT)
Time Frame: Baseline
NDT is a clinical method for assessing the mobility of the medial longitudinal arch (MLA). The height difference between the two measurements in weight bearing and nonweight bearing is recorded as the NDT value. Values more than 10mm is accepted as pathological. The investigators will assess NDT only one time.
Baseline
Calcaneotibial Angle Measurement (CAM)
Time Frame: Baseline
In the CTA measurement, the angle between the vertical axis of the calcaneus and the longitudinal axis of the achilles tendon is measured in the standing and prone positions, and the differences will be recorded. Values more than 8 degrees is accepted as calcaneal valgus. The investigators will assess CAM only one time.
Baseline
Tibial Torsion Angle (TTA)
Time Frame: Baseline
TTA Measurement will be done by a goniometer. Participants will be asked to lie prone and will be positioned with the knee joint in 90° flexion and the ankle joint in a neutral position. Normal alignment is 20 degrees external rotation. Any increase or decrease accepted as pathological.
Baseline
Femoral internal and external rotation measurement
Time Frame: Baseline
The expected hip rotational range of motion for internal rotation (IR) is 45°, and for external rotation (ER) is 0° to 45°. In this study, a smartphone-based inclinometer will be used to measure femoral IR and ER in sitting position.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bahçeşehir University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Acibadem University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pelin Pişirici, PhD, PT, Bahçeşehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
  • Study Director: Özlem Karakaş Fevzioğlu, PhD, PT, Acibadem University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
  • Principal Investigator: Gülsüm Bayıroğlu, PT, Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LEA-BAU-AU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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