Balance DisordersNCT06300671
The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance
A study testing Foot Posture Index-6 in people with Balance Disorders and Foot Injury, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Disorders, Foot Injury, Lower Extremity Problem
- What is being tested?
- Foot Posture Index-6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir University
Beşiktaş, Istanbul, 34353
About this study
Official title: Investigation of the Effects of Different Subtalar Joint Pronation Amounts on Lower Extremity Anatomical Measurements, Jump Performances and Postural Stability in Healthy Individuals
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.
Read the detailed description
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
- Balance Disorders, Foot Injury, Lower Extremity Problem
- Being tested
- Foot Posture Index-6
- Keywords
- Subtalar joint, Hyperpronation, Kinetic Chain, Balance
- Medical subject headings
- Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Posture Index-6Other
Also called Postural stability Assessment, Frontal Plane Projection Angle, Foot and Ankle Ability Measurement, Navicular Drop test
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.
| Study group | Role | What they receive |
|---|---|---|
| Pronation Group | Active comparator | Participants with a value between 6-9 according to the foot posture index-6 evaluation will be included in the pronation group. Receives: Other: Foot Posture Index-6 |
| Hyperpronation Group | Active comparator | Participants with a value between 10-12 according to the foot posture index-6 evaluation will be included in the hyperpronation group. Receives: Other: Foot Posture Index-6 |
| Neutral Group | Active comparator | Participants with a value between 0-5 according to the foot posture index-6 evaluation will be included in the neutral group. Receives: Other: Foot Posture Index-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability
Static and dynamic balance assessments The Biodex Balance System (BDS) (Biodex Medical Systems Inc., Shirley, New York, USA) will be used. Measurements will be made with bare feet. Each test will last 20 seconds and will be made in 3 measurements with 10-second rest periods. During the measurement, individuals will be asked to stand on their weight-bearing knees in 15° flexion, their non-weight-bearing contralateral knees in 90° flexion, and to look forward by crossing their arms at chest level. In dynamic balance evaluation, the difficulty level of the test will be set to 4.
Measured: Baseline
Secondary outcomes (5)
Frontal Plane Projection Angle
During the frontal plane projection angle (FPPA) measurement, a straight line will be drawn from the anterior superior spina iliaca along the femur to the midpoint of the patella, and the midpoint of the ankle will be determined as the reference point by a straight line drawn from the midpoint of the patella. Participants will stand with their feet aligned in the sagittal plane and their arms crossed across their chests. By prior instruction, subjects will be asked to squat up to 60º knee flexion in a controlled manner without losing their balance, before returning to the starting position. Digital recordings of the frontal plane will be made while individuals perform a single-leg squat test at 60º knee flexion 3 times. The FPPA degree is measured from the medial aspect of the knee and calculated by subtracting 360. FPPA of 195° and above will be considered pathological.
Measured: Baseline
Foot and Ankle Ability Measurement
The Foot and Ankle Ability measurement scale consists of daily living activities and sports subheadings. The scale includes 29 items scored between 0 and 4. Standardized answer options are answered using five-point Likert options ranging from 0 (I cannot do it) to 4 (No difficulty). From the participants; They are asked to mark the activity as no difficulty (4 points), mild difficulty (3 points), moderate difficulty (2 points), extreme difficulty (1 point), cannot do (0 points) or N/A (not applicable). High scores; It shows more functional ability.
Measured: Baseline
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.
Measured: Baseline
Weight bearing lunge test
Weight-bearing lunge test (WBLT) is frequently used in individuals with ankle instability in order to determine dorsiflexion normal joint movement. During WBLT the participant puts their hands on the wall and takes one leg forward and the other leg helps balance behind. The maximum distance that the knee touches the wall is recorded without allowing the heel of the front foot to lose contact with the ground.
Measured: Baseline
Countermovement jump test without arm swing
In the starting position of the test, participants stood in the middle of the Optojump device with their feet hip-width apart. With hands on hips, participants were asked to squat until their thighs were parallel to the ground and then immediately jump up. Bending the hips and knees before landing; Participants were instructed to keep their hands on their hips and legs in extension, maintaining this position during the jump and even when they landed, as this would increase flight time and reduce the accuracy and reliability of the results. During testing, all participants wore sneakers. The test was repeated 3 times and the best value was recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Dec 2023
- Primary completion30 Apr 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance DisordersStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 48 healthy individuals between the ages of 18-40 constitute the population of the study. Participants randomized into neutral, pronation, and hyperpronation groups.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Pişirici, Bahçeşehir University
- Investigators
- Pelin Pişirici, PT, PhD, Principal investigator, Bahcesehir University, Faculty of Health SciencesOzlem Feyzioğlu, PT, PhD, Study chair, Acibadem Mehmet Ali Aydinlar University, Faculty of Health SciencesNurefşan Kaygaz, PT, Study chair, Bahcesehir University, Health Sciences Faculty, Physiotherapy and RehabilitationYahya Süleyman Mollaibrahimoğlu, PT, Study chair, Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300671
- Sponsor's protocol ID
- PNSÖ-Subtalar pronation
- Status last verified
- Jul 2024
- First submitted
- 6 Feb 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Different Subtalar Joint Pronation Amounts on Lower Extremity Anatomical Measurements, Jump Performances and Postural Stability in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06300671
- Acronym / sponsor ID
- PNSÖ-Subtalar pronation
- Conditions
- Balance Disorders, Foot Injury, Lower Extremity Problem
- Keywords
- Subtalar joint, Hyperpronation, Kinetic Chain, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Mar 2024 (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 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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 48 healthy individuals between the ages of 18-40 constitute the population of the study. Participants randomized into neutral, pronation, and hyperpronation groups.
| Arm | Type | Receives |
|---|---|---|
| Pronation Group | Active comparator | Other: Foot Posture Index-6Participants with a value between 6-9 according to the foot posture index-6 evaluation will be included in the pronation group. |
| Hyperpronation Group | Active comparator | Other: Foot Posture Index-6Participants with a value between 10-12 according to the foot posture index-6 evaluation will be included in the hyperpronation group. |
| Neutral Group | Active comparator | Other: Foot Posture Index-6Participants with a value between 0-5 according to the foot posture index-6 evaluation will be included in the neutral group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Foot Posture Index-6Also: Postural stability Assessment, Frontal Plane Projection Angle, Foot and Ankle Ability Measurement, Navicular Drop testFoot 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. | Other | Hyperpronation Group, Neutral Group, Pronation Group |
Primary outcome
Postural Stability
Time frame: Baseline
Static and dynamic balance assessments The Biodex Balance System (BDS) (Biodex Medical Systems Inc., Shirley, New York, USA) will be used. Measurements will be made with bare feet. Each test will last 20 seconds and will be made in 3 measurements with 10-second rest periods. During the measurement, individuals will be asked to stand on their weight-bearing knees in 15° flexion, their non-weight-bearing contralateral knees in 90° flexion, and to look forward by crossing their arms at chest level. In dynamic balance evaluation, the difficulty level of the test will be set to 4.
5 secondary outcomes
Frontal Plane Projection Angle
Time frame: Baseline
Foot and Ankle Ability Measurement
Time frame: Baseline
Navicular Drop Test
Time frame: Baseline
Weight bearing lunge test
Time frame: Baseline
Countermovement jump test without arm swing
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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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. This study is not recruiting at the moment.
Pelin Pişirici, PT, PhD principal investigator
Bahcesehir University, Faculty of Health Sciences
Ozlem Feyzioğlu, PT, PhD study chair
Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences
Nurefşan Kaygaz, PT study chair
Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Posture Index-6 in people with Balance Disorders and Foot Injury, run by Bahçeşehir University at 1 site 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.