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

NCT06128642 | Completed

• 1 other identifier: MedipolUniversity
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hallux Valgus

Keywords

Dynamic orthosis; Toe separator orthosis; Hallux valgus angle; Plantar pressure analysis; orthosis satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

  2 minute

• 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.

  2 minute

Secondary Outcomes (2)

• Foot Questionnaire

  5 minute

• Evaluation of orthosis satisfaction

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

Study Arms (2)

Toe separator orthosis

The 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.

Device: Toe separator orthosis

Dynamİc orthosis

The 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.

Device: Dynamic orthosis

Interventions

Toe separator orthosis DEVICE

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.

Toe separator orthosis

Dynamic orthosis DEVICE

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.

Dynamİc orthosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Sena Özdemir Görgü

Istanbul, 34810, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39721066 DERIVED

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• SENA ÖZDEMİR GÖRGÜ, PhD

  Istanbul Medipol Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: November 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)