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Hallux ValgusNCT06128642

Comparison of the Effects of Two Different Orthoses on Individuals With Hallux Valgus

An observational study of Hallux Valgus, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hallux valgus (HV) is a tri-planar, painful and common foot deformity characterized by the medial orientation of the first metatarsal, lateral deviation and pronation of the big toe at the level of the first metatarsophalangeal joint. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hallux Valgus
What is being tested?
Toe separator orthosis and Dynamic orthosis
Type of treatment
Medical device
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Nov 2023to 31 Jan 2024
How long will I take part?
1 Month
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: To determine the participants, it is planned to prepare a poster with the visual of hallux valgus deformity, create it in physical forms, hang it on notice boards and share it online. Volunteers who want to participate in the study will be contacted and invited to be evaluated. Participants who meet the inclusion and exclusion criteria determined in the study will be included in the study.

Who may be able to join

  • Being between the ages of 18-65,
  • Having mild to moderate hallux valgus deformity.

Who cannot join

  • Individuals have cognitive, mental or psychological problems,
  • Having previously used orthosis treatment for hallux valgus,
  • Having a history of surgery on the foot,
  • Presence of rheumatoid arthritis disease,
  • Hallux valgus deformity is rigid.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sena Özdemir Görgü

    Istanbul, 34810

Other trials in Turkey (Türkiye)

About this study

Hallux valgus (HV) is a tri-planar, painful and common foot deformity characterized by the medial orientation of the first metatarsal, lateral deviation and pronation of the big toe at the level of the first metatarsophalangeal joint. Due to the increase in the severity of hallux valgus deformity, dissatisfaction with the appearance of the foot, difficulty choosing shoes due to bunions and pain, difficulty walking and accordingly, restriction in daily activities, the functional levels and health-related quality of life of individuals are negatively affected. The aim of this study is to compare the effect of using a toe separator orthosis and dynamic orthosis for 1 month on hallux valgus angle and plantar pressure in individuals with hallux valgus.

Read the detailed description

If left untreated, hallux valgus becomes a painful and progressive disease of the big toe that severely restricts the patient's daily activities and disrupts the aesthetic appearance of the foot. As the deformity progresses, dissatisfaction with the appearance of the foot, difficulty in choosing shoes, difficulty in walking and, accordingly, limitation in daily activities, arch pathologies Individuals' health-related quality of life and functional levels are negatively affected due to problems such as nail problems, bunions and callus formations.

Surgical and conservative treatment methods are used in the treatment of hallux valgus deformity. Conservative treatment methods are more preferred due to possible complications of surgical treatment methods such as infection, skin problems, bone nonunion, bone malunion, hallux valgus and complex regional pain syndrome. Conservative treatment methods aim to reduce the hallux valgus angle (HVA) in individuals with hallux valgus deformity, reduce pain and prevent the severity of the deformity from increasing.

Different orthosis applications are used in the conservative treatment of hallux valgus deformity. In the literature, it is reported that finger spreader orthosis, dynamic orthosis, and night orthosis are effective in the treatment of mild and moderate hallux valgus deformities. The most commonly used finger separator orthoses and dynamic orthoses in clinics are orthoses with proven effectiveness in the treatment of hallux valgus deformity, but there is no study comparing the effectiveness of these orthoses. The purpose of this study is to examine the effect of toe separation orthosis and dynamic orthosis on hallux valgus angle and plantar pressure.

The individuals included in the study will be randomly divided into two groups: those using the finger separation orthosis and those using the dynamic orthosis.

Foot pressure analysis after the participants use the toe separation orthosis and dynamic orthosis for 1 month will be evaluated. Pressure analysis evaluation will be performed 3 times; before using the orthosis, when first wearing the orthosis, and 1 month after using the orthosis.

Individuals participating in the study must first sign the informed consent form. Individuals who agree to participate in the study will fill out the socio-demographic evaluation form.

According to the Manchester Scale, the individual's hallux valgus deformity will be classified according to its severity.

Hallux valgus angle measurement will be made with a goniometer. In order to understand the effect of deformity on individuals, the Foot Function Index Evaluation Form will be filled out by individuals. For the pain, function and alignment evaluation of individuals, the evaluation form prepared by the American Orthopedic Foot-Ankle Society (AOFAS) will be answered by individuals. The Manchester-Oxford foot questionnaire will be administered to assess standing, walking and quality of life.

The orthoses to be used during the study will be randomly distributed to the individuals participating in the study. Plantar pressure analysis will be performed without orthosis, with orthosis and 1 month after the use of orthosis. At the end of the 1-month period during which individuals use the orthoses, patient orthosis satisfaction will be evaluated.

Socio-Demographic evaluation will include physical evaluations such as individuals' name, surname, age, weight and body mass index. For social evaluation, individuals' education level, profession and job status will be asked. Questions that are important for the research are included in the socio-demographic evaluation. For this study, individuals will be asked about their shoe choice, average number of steps per day, average standing time per day, presence of hallux valgus, and presence of hallux valgus in the family. Additionally, the foot will be evaluated and the presence of pes planus will be examined.

It is a scale developed by Garrow to classify hallux valgus deformity. It deals with hallux valgus deformity at 4 levels; none (1), mild (2), moderate (3), severe (4). The classification is evaluated by comparing 4 different photographs containing the hallux valgus deformity between individuals with the deformity.

A universal standard goniometer will be used to measure the hallux valgus angle. To measure the hallux valgus angle, the pivot part of the goniometer is placed in the 1st Metatarsophalangeal joint. One arm of the goniometer is placed parallel to the 1st Metatarsal bone and the other arm is parallel to the proximal phalanx, the angle between them is measured and the hallux valgus angle is found. Hallux valgus angle is classified as normal (<15°), mild (15-20°), moderate (20°-40°) and severe (>40°).

Foot function index is a widely used form that can be filled out by the person himself, developed to measure the effects of foot pathologies on pain, disability and activity limitation.

Foot function index is used in research on children, adults and older adults to determine the effectiveness of treatment for various foot and ankle problems such as congenital, acute and chronic diseases and injuries, as well as after surgical interventions or orthosis use.

Foot function index; It consists of 23 items with 3 subgroups: pain, disability and activity limitation. While the nine-item pain subscale measures the level of foot pain in various situations, the 9-item disability subscale determines the degree of difficulty in performing various functional activities due to foot problems. With the activity limitation subscale, which includes five items, activity limitations due to foot problems are evaluated.Foot function index is a widely used form that can be filled out by the person himself, developed to measure the effects of foot pathologies on pain, disability and activity limitation.

Foot function index is used in research on children, adults and older adults to determine the effectiveness of treatment for various foot and ankle problems such as congenital, acute and chronic diseases and injuries, as well as after surgical interventions or orthosis use.

Foot function index; It consists of 23 items with 3 subgroups: pain, disability and activity limitation. While the nine-item pain subscale measures the level of foot pain in various situations, the 9-item disability subscale determines the degree of difficulty in performing various functional activities due to foot problems. With the activity limitation subscale, which includes five items, activity limitations due to foot problems are evaluated. Patients score all items with the Visual Analogue Scale (VAS), taking into account their foot conditions one week ago. To calculate the subscales and total score, the scores of each item are summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate greater pain, disability, and activity limitation. Turkish validity study was conducted.

American Orthopedics Foot and Ankle Society (AOFAS); Separate scales were created for four different parts of the foot; The ankle-hindfoot scale (AHFS) is a scale for the midfoot, a scale for the metatarsophalangeal and interphalangeal joints of the hallux (AOFAS-MTF-IF), and a scale for the metatarsophalangeal and interphalangeal joints of the other toes, allowing their application to different types of injuries and treatments. For this study, function, pain and alignment will also be evaluated with the AOFAS-MTF-IF scale. Pain is evaluated over 40 points, function is evaluated over 45 points, and alignment is evaluated over 15 points. A total of 100 points are collected in the evaluation. While low scores indicate poor prognosis, high scores indicate good prognosis. Turkish validity study was conducted.

The Manchester-Oxford Foot Questionnaire (MOXFQ) is a practical, valid and reliable questionnaire that accurately assesses patients with hallux valgus. The MOXFQ is a recently designed, patient-reported outcome measure developed with patients so that it adequately records their perception of their symptoms. Accordingly, MOXFQ is a suitable scale for evaluating the functional and social effects of individuals with hallux valgus on walking, standing and quality of life, as well as pain. This questionnaire is therefore very useful and can be used in clinical trials and for comparison between groups undergoing different treatment options. Turkish validity study was conducted.

To measure the pressure distribution during walking, it will be done with the Sensor Medica brand, which is the plantar pressure measurement system within the Prosthesis / Orthosis Center (POMER) at Istanbul Medipol University. Free Step software compatible with the device will be used during pressure measurement.

Plantar pressure analysis refers to the measurement of the magnitude and distribution of the force applied to the plantar surface of the foot during walking. Plantar pressure analysis will be performed with the Sensor Medica device, which consists of pressure-sensitive sensors. Participants will wear socks during pressure measurement. Plantar pressure analysis will be performed on the participants 3 (three) times: without orthosis, when wearing the orthosis for the first time and 1 (one) month after using the orthosis.

To measure orthosis satisfaction after orthosis use, orthosis quality, comfort in orthosis use, difficulty of putting on and taking off, and suitability of the material will be evaluated. After using the orthosis, participants will evaluate these parameters with scores from 0 to 10. A score of 0 indicates that they are not at all satisfied with the orthosis, 5 points indicate neutral status, and 10 points indicate that they are very satisfied with the orthosis. Participants will express orthosis satisfaction by scoring the parameters in this way.

Conditions
Hallux Valgus
Being tested
Toe separator orthosis, Dynamic orthosis
Keywords
Dynamic orthosis, Toe separator orthosis, Hallux valgus angle, Plantar pressure analysis, orthosis satisfaction
Medical subject headings
Hallux Valgus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toe separator orthosisDevice

    The orthoses to be used during the study will be randomly distributed to the individuals participating in the study. Foot pressure analysis will be evaluated after the participants use the toe separation orthosis for 8 hours a day, for a total of 1 month.

    Plantar pressure analysis will be performed again without orthosis, with orthosis and 1 month after the use of orthosis. Additionally, patient orthosis satisfaction evaluation will be made at the end of the 1-month period during which the participants use the orthoses.

  • Dynamic orthosisDevice

    The orthoses to be used during the study will be randomly distributed to the individuals participating in the study. Foot pressure analysis will be evaluated after participants use the dynamic orthosis for 8 hours a day, for a total of 1 month.

    Plantar pressure analysis will be performed again without orthosis, with orthosis and 1 month after the use of orthosis. Additionally, patient orthosis satisfaction evaluation will be made at the end of the 1-month period during which the participants use the orthoses.

Study groups in NCT06128642
Study groupRoleWhat they receive
Toe separator orthosisThe silicone toe spreader orthosis does not use tape or straps to separate the first and second toes and pull them medially to realign the first metatarsal. Orthotics reduce the pain in the bunion area by reducing the high friction between the shoe and the bunion. Participants will be asked to use their orthoses for an average of 8 hours per day for 1 month.
Receives: Device: Toe separator orthosis
Dynamİc orthosisThe dynamic orthosis contains a free joint that does not hinder the movement of the first metatarsophalangeal joint. The working principle of the orthosis is to provide healing of the deformity with low torque and long-term stretching. The dynamic orthosis corrects the hallux valgus angle by realigning the hallux, thus allowing plantarflexion and dorsiflexion. Participants will be asked to use their orthoses for an average of 8 hours per day for 1 month.
Receives: Device: Dynamic orthosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hallux valgus angle

    A goniometer will be used to measure the participants' degree of hallux valgus. Hallux valgus measurement of all participants will be performed by a single researcher.

    In measurement with goniometer; The hallux valgus angle will be obtained by placing the pivot part of the goniometer on the participant's foot parallel to the metatarsophalangeal joint, one arm parallel to the first metatarsophalangeal joint and the other parallel to the proximal phalanx, and measuring the angle between them.

    Measured: 2 minute

  2. Plantar pressure

    To measure the pressure distribution of the participants, the Sensor Medica device, the Free Step software compatible with the device will be used.

    The platform of the device is the FreeMed Maxi Baropodometric Platform. It is a pedobarographic evaluation device with a size of 60x50 cm, made of platform aluminum, capable of measuring a maximum pressure of 150 N/cm², with 2.5 dpi XY, 8 bit Z resolution, 3,000 sensors, and a sensor life of 1,000,000 cycles. In our study, static pressure analysis will be performed. During the analysis, the individual will be asked to stand on the platform facing forward, press the 'start' button in the program while his eyes are open on the platform as specified, and the patient will be asked to stand on the platform for 5 seconds without moving.

    Within the scope of static analysis measurements; Left-right forefoot, hindfoot and total foot loading percentages, left-right forefoot, hindfoot weight ratio percentage data will be recorded.

    Measured: 2 minute

Secondary outcomes (2)
  1. Foot Questionnaire

    The Manchester-Oxford Foot Questionnaire (MOXFQ) is a recently designed, patient-reported outcome measure developed with patients so that it adequately records their perception of their symptoms. Accordingly, MOXFQ is a suitable scale for evaluating the functional and social effects of individuals with hallux valgus on walking, standing and quality of life, as well as pain.

    MOXFQ consists of 3 subheadings that are scored separately; It consists of a total of 16 questions: foot pain (5 questions), walking and standing (7 questions), and social interaction (4 questions). Each of the questions has 5 different answer options and is scored between 0-4, with 4 points representing a very severe situation. The score for each subheading ranges from 0 to 100; A score of 0 indicates the best possible clinical situation, and a score of 100 indicates the worst possible situation.

    Measured: 5 minute

  2. Evaluation of orthosis satisfaction

    A satisfaction evaluation will be made for the participants in the study after using the hallux valgus orthosis. The numerical evaluation created by us will be used to evaluate the participants' orthosis satisfaction. The parameters evaluated in orthosis satisfaction are orthosis quality, comfort in using the orthosis, difficulty of wearing and removing it, and suitability of the material. After using the orthosis, participants will evaluate these parameters with scores from 0 to 5. A score of 0 indicates that you are not at all satisfied with the orthosis, 3 points indicate neutral status, and 5 points indicate that you are very satisfied with the orthosis. Participants will evaluate orthosis satisfaction by scoring the parameters in this way.

    Measured: It takes the participant a maximum of 2 minutes to fill out the form.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start20 Nov 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Jan 2024

Resources

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 crossover
Time perspective
Prospective
Enrolment
34 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT06128642
Sponsor's protocol ID
MedipolUniversity
Status last verified
Feb 2024
First submitted
8 Nov 2023
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Camur H, Ozdemir Gorgu S. Comparison of the effects of orthoses on hallux valgus angle and plantar pressure in individuals with hallux valgus. Prosthet Orthot Int. 2025 Oct 1;49(5):494-501. doi: 10.1097/PXR.0000000000000423. Epub 2024 Dec 24.

    PubMed 39721066

Questions about this trial

What is this clinical trial studying?

An observational study of Hallux Valgus, run by Istanbul Medipol University Hospital 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 2 inclusion and 5 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 21 Feb 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?

Hallux valgus angle (time frame: 2 minute). The study lists 2 primary outcomes in all. 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 NCT06128642, which also lists 1 linked publication.

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 21 Feb 2024.

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