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

NCT06128642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2024-02-21

No results posted yet for this study

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

Interventions

DEVICE

Toe separator orthosis

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.

DEVICE

Dynamic orthosis

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.

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    lead OTHER

Principal Investigators

  • SENA ÖZDEMİR GÖRGÜ, PhD · Istanbul Medipol Universty

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128642 on ClinicalTrials.gov