Foot; Deformity, Valgus, CongenitalNCT05437042
Effect of Medial Wedge on Static Balance in Pronated Feet
An observational study of Foot; Deformity, Valgus, Congenital and Foot; Deformity, Valgus (Acquired), run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The use of heel wedges is often recommended as a clinical routine in individuals with foot pronation. However, there is a lack of information for examining the immediate effect of supports used to restore foot biomechanics on balance. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot; Deformity, Valgus, Congenital, Foot; Deformity, Valgus (Acquired), Foot Deformities
- What is being tested?
- Medial calcaneal wedge
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Jan 2022
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults who has pronated foot
Who may be able to join
- Standing subtalar angle of 5° or more
- Foot Posture Index score of 6 or more
- Right lower limb dominance
- Agreeing to participate in the study voluntarily
Who cannot join
- Having a neurological or orthopedic problem
- Having any surgery on the lower extremity
- Having a foot-ankle complex Visual Analog Scale (VAS) pain score above 6.4
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, Sıhhiye
About this study
Official title: Does Medial Calcaneal Wedge Improve Static Balance and Load Distribution in Young Adults With Pronated Foot?
The use of heel wedges is often recommended as a clinical routine in individuals with foot pronation. However, there is a lack of information for examining the immediate effect of supports used to restore foot biomechanics on balance. The aim of our study is to examine the immediate effect of calcaneal support in the frontal plane on static balance in individuals with increased pronated foot. In this study, the fore-hind foot load distribution in static bipedal stance will be examined in healthy young adults. Then, static balance measurements will be made on one leg with and without support (medial heel wedge). For the evaluation of static balance on one leg, x-y mean, ellipse surface, A-P index measurements and romberg test will be used. In addition, the pain of individuals will be questioned and their foot postures will be evaluated. Healthy young adult individuals with a subtalar angle of 5 degrees and above in the weighted position will be included in the evaluations. Evaluations of the participants are planned to take approximately 15 minutes.
Read the detailed description
In a normal foot, the subtalar joint is pronated from heel strike to sole contact, which makes the midtarsal joint and forefoot flexible. Between sole contact and toe lift, the subtalar joint becomes supinated and the foot turns into a rigid lever (1,2). Hindfoot overpronation can be defined as pronation of the subtalar joint during gait phases in which supination is normal. It can cause problems such as abnormal pronation in the foot, increased flexibility, deterioration in load distribution, hallux valgus and heel spurs, and postural disorders involving the leg, knee, hip and spine (3). In addition, the increase in rear foot pronation negatively affects the physical performance of individuals such as jumping and running (4). Commonly used conservative methods to prevent pronation in the subtalar joint include exercises to support the medial arch, strengthen muscles and ligaments, electrical stimulation, insoles, wedges, and applications such as flexible and inflexible taping techniques (1,5).
Medial wedge is a method frequently preferred by physiotherapists in terms of ease of use among the methods used in the routine. It is thought that the contact of the medial longitudinal arch support of the insole with the foot prevents the increase in pronation of the foot and reduces the load on the arch structures. The medial longitudinal arch support transfers the load on the heel region to the midfoot and the decrease in maximum pressure in the 2nd and 3rd metatarsal regions is explained by the insoles turning the foot towards supination. It is stated that excessive pronation of the hindfoot and the secondary deformities it may cause can be prevented by the use of simple supports applied under the foot.
The foot is located at the most distal point and acts as the support base for this kinematic chain. For this reason, the smallest dynamic change in the foot affects the balance of the whole body (6). Balance is the ability to keep the body's center of gravity within the acceptable limits of the support surface during activities such as sitting, standing or walking, and it is a complex process that includes versatile sensory, motor and biomechanical components (7).
It is known that foot deformities in seniors negatively affect balance and cause falls (8). Along with the changes in the gravity line in neurological diseases, problems are seen in maintaining the balance starting from the sitting level and in situations that require a change in movement. Conditions such as loss of balance or inability to maintain body position in athletes may prevent the athlete from performing the expected performance, as well as cause injuries (9). Balance improvement has an important place in every field of physiotherapy. Improving balance, increasing function in the athlete, improving performance; To ensure the continuity of mobility in neuromuscular diseases and neurological problems, to increase the quality of life; in healthy individuals, it is important to prevent injuries. In this study, the immediate effect of the medial heel wedge on static balance and weight distribution in individuals with pronated foot was investigated.
- Conditions
- Foot; Deformity, Valgus, Congenital, Foot; Deformity, Valgus (Acquired), Foot Deformities, Flatfoot
- Being tested
- Medial calcaneal wedge
- Keywords
- Foot Orthoses, Postural Balance, Subtalar Joint
- Medical subject headings
- Congenital Abnormalities, Genu Valgum, Foot Deformities, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial calcaneal wedgeOther
Immediate effect of medial calcaneal wedge for static balance and weight distribution
| Study group | Role | What they receive |
|---|---|---|
| Individuals with pronated foot | Not described Receives: Other: Medial calcaneal wedge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate effect of medial heel wedge on static balance
Measured: Day 1
Secondary outcomes (1)
Immediate effect of medial heel wedge on load distribution
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Apr 2021
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Foot; Deformity, Valgus, CongenitalStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izgi Guven, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437042
- Sponsor's protocol ID
- HU/PAU/GUVEN-001
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leung AK, Mak AF, Evans JH. Biomedical gait evaluation of the immediate effect of orthotic treatment for flexible flat foot. Prosthet Orthot Int. 1998 Apr;22(1):25-34. doi: 10.3109/03093649809164454.
PubMed 9604273McPoil TG, Hunt GC. Evaluation and management of foot and ankle disorders: present problems and future directions. J Orthop Sports Phys Ther. 1995 Jun;21(6):381-8. doi: 10.2519/jospt.1995.21.6.381.
PubMed 7655482Valmassy RL. clinical biomechanics of the lower extermities. Mosby, Missouri. 1996;12:143-5.
Kararti C, Bilgin S, Buyukturan O, Buyukturan B. Arka Ayaktaki Pronasyon Artisinin Fiziksel Performans Uzerine Etkisi. Hacettepe University Faculty of Health Sciences Journal. 2018;5(1):1-0.
Hadley A, Griffiths S, Griffiths L, Vicenzino B. Antipronation taping and temporary orthoses. Effects on tibial rotation position after exercise. J Am Podiatr Med Assoc. 1999 Mar;89(3):118-23. doi: 10.7547/87507315-89-3-118.
PubMed 10095333Al Abdulwahab SS, Kachanathu SJ. The effect of various degrees of foot posture on standing balance in a healthy adult population. Somatosens Mot Res. 2015;32(3):172-6. doi: 10.3109/08990220.2015.1029608. Epub 2015 Sep 7.
PubMed 26400632Winter DA. Human balance and posture control during standing and walking. Gait & posture. 1995 Dec 1;3(4):193-214.
Whitney KA. Foot deformities, biomechanical and pathomechanical changes associated with aging including orthotic considerations, Part II. Clin Podiatr Med Surg. 2003 Jul;20(3):511-26, x. doi: 10.1016/S0891-8422(03)00046-6.
PubMed 12952051Borklu T, Dolu N. Sporcularda Isitsel Uyarilma Potansiyellerindeki Hemisferik Farkliliklar. Sağlık Bilimleri Dergisi (Journal of Health Sciences). 2010;19(2):108-18.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Medial Calcaneal Wedge Improve Static Balance and Load Distribution in Young Adults With Pronated Foot?
- ClinicalTrials.gov ID
- NCT05437042
- Acronym / sponsor ID
- HU/PAU/GUVEN-001
- Conditions
- Foot; Deformity, Valgus, Congenital, Foot; Deformity, Valgus (Acquired), Foot Deformities, Flatfoot
- Keywords
- Foot Orthoses, Postural Balance, Subtalar Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 29 Jun 2022 (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 use of heel wedges is often recommended as a clinical routine in individuals with foot pronation. However, there is a lack of information for examining the immediate effect of supports used to restore foot biomechanics on balance. The aim of our study is to examine the immediate effect of calcaneal support in the frontal plane on static balance in individuals with increased pronated foot. In this study, the fore-hind foot load distribution in static bipedal stance will be examined in healthy young adults. Then, static balance measurements will be made on one leg with and without support (medial heel wedge). For the evaluation of static balance on one leg, x-y mean, ellipse surface, A-P index measurements and romberg test will be used. In addition, the pain of individuals will be questioned and their foot postures will be evaluated. Healthy young adult individuals with a subtalar angle of 5 degrees and above in the weighted position will be included in the evaluations. Evaluations of the participants are planned to take approximately 15 minutes.
Detailed description
In a normal foot, the subtalar joint is pronated from heel strike to sole contact, which makes the midtarsal joint and forefoot flexible. Between sole contact and toe lift, the subtalar joint becomes supinated and the foot turns into a rigid lever (1,2). Hindfoot overpronation can be defined as pronation of the subtalar joint during gait phases in which supination is normal. It can cause problems such as abnormal pronation in the foot, increased flexibility, deterioration in load distribution, hallux valgus and heel spurs, and postural disorders involving the leg, knee, hip and spine (3). In addition, the increase in rear foot pronation negatively affects the physical performance of individuals such as jumping and running (4). Commonly used conservative methods to prevent pronation in the subtalar joint include exercises to support the medial arch, strengthen muscles and ligaments, electrical stimulation, insoles, wedges, and applications such as flexible and inflexible taping techniques (1,5).
Medial wedge is a method frequently preferred by physiotherapists in terms of ease of use among the methods used in the routine. It is thought that the contact of the medial longitudinal arch support of the insole with the foot prevents the increase in pronation of the foot and reduces the load on the arch structures. The medial longitudinal arch support transfers the load on the heel region to the midfoot and the decrease in maximum pressure in the 2nd and 3rd metatarsal regions is explained by the insoles turning the foot towards supination. It is stated that excessive pronation of the hindfoot and the secondary deformities it may cause can be prevented by the use of simple supports applied under the foot.
The foot is located at the most distal point and acts as the support base for this kinematic chain. For this reason, the smallest dynamic change in the foot affects the balance of the whole body (6). Balance is the ability to keep the body's center of gravity within the acceptable limits of the support surface during activities such as sitting, standing or walking, and it is a complex process that includes versatile sensory, motor and biomechanical components (7).
It is known that foot deformities in seniors negatively affect balance and cause falls (8). Along with the changes in the gravity line in neurological diseases, problems are seen in maintaining the balance starting from the sitting level and in situations that require a change in movement. Conditions such as loss of balance or inability to maintain body position in athletes may prevent the athlete from performing the expected performance, as well as cause injuries (9). Balance improvement has an important place in every field of physiotherapy. Improving balance, increasing function in the athlete, improving performance; To ensure the continuity of mobility in neuromuscular diseases and neurological problems, to increase the quality of life; in healthy individuals, it is important to prevent injuries. In this study, the immediate effect of the medial heel wedge on static balance and weight distribution in individuals with pronated foot was investigated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with pronated foot | – | Other: Medial calcaneal wedge |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults who has pronated foot
Key inclusion criteria (4 listed)
- Standing subtalar angle of 5° or more
- Foot Posture Index score of 6 or more
- Right lower limb dominance
- Agreeing to participate in the study voluntarily
Key exclusion criteria (3 listed)
- Having a neurological or orthopedic problem
- Having any surgery on the lower extremity
- Having a foot-ankle complex Visual Analog Scale (VAS) pain score above 6.4
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 |
|---|---|---|
| Medial calcaneal wedgeImmediate effect of medial calcaneal wedge for static balance and weight distribution | Other | Individuals with pronated foot |
Primary outcome
Immediate effect of medial heel wedge on static balance
Time frame: Day 1
1 secondary outcome
Immediate effect of medial heel wedge on load distribution
Time frame: Day 1
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 6 Jul 2022.
- Background: PubMed 9604273Leung AK, Mak AF, Evans JH. Biomedical gait evaluation of the immediate effect of orthotic treatment for flexible flat foot. Prosthet Orthot Int. 1998 Apr;22(1):25-34. doi: 10.3109/03093649809164454.
- Background: PubMed 7655482McPoil TG, Hunt GC. Evaluation and management of foot and ankle disorders: present problems and future directions. J Orthop Sports Phys Ther. 1995 Jun;21(6):381-8. doi: 10.2519/jospt.1995.21.6.381.
- BackgroundValmassy RL. clinical biomechanics of the lower extermities. Mosby, Missouri. 1996;12:143-5.
- BackgroundKararti C, Bilgin S, Buyukturan O, Buyukturan B. Arka Ayaktaki Pronasyon Artisinin Fiziksel Performans Uzerine Etkisi. Hacettepe University Faculty of Health Sciences Journal. 2018;5(1):1-0.
- Background: PubMed 10095333Hadley A, Griffiths S, Griffiths L, Vicenzino B. Antipronation taping and temporary orthoses. Effects on tibial rotation position after exercise. J Am Podiatr Med Assoc. 1999 Mar;89(3):118-23. doi: 10.7547/87507315-89-3-118.
- Background: PubMed 26400632Al Abdulwahab SS, Kachanathu SJ. The effect of various degrees of foot posture on standing balance in a healthy adult population. Somatosens Mot Res. 2015;32(3):172-6. doi: 10.3109/08990220.2015.1029608. Epub 2015 Sep 7.
- BackgroundWinter DA. Human balance and posture control during standing and walking. Gait & posture. 1995 Dec 1;3(4):193-214.
- Background: PubMed 12952051Whitney KA. Foot deformities, biomechanical and pathomechanical changes associated with aging including orthotic considerations, Part II. Clin Podiatr Med Surg. 2003 Jul;20(3):511-26, x. doi: 10.1016/S0891-8422(03)00046-6.
- BackgroundBorklu T, Dolu N. Sporcularda Isitsel Uyarilma Potansiyellerindeki Hemisferik Farkliliklar. Sağlık Bilimleri Dergisi (Journal of Health Sciences). 2010;19(2):108-18.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot; Deformity, Valgus, Congenital and Foot; Deformity, Valgus (Acquired), run by Pamukkale 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 4 inclusion and 3 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 6 Jul 2022. 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?
Immediate effect of medial heel wedge on static balance (time frame: Day 1). 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 NCT05437042, which also lists 9 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 6 Jul 2022.