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Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation

Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07000838
Enrollment
52
Registered
2025-06-03
Start date
2025-05-09
Completion date
2026-09-18
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperpronation, Overpronation, Pes Planus

Brief summary

Foot hyperpronation is a common postural condition that can lead to pain, deformities (such as hallux valgus), and muscular issues. This problem is especially relevant among adults who spend long hours standing, such as healthcare workers. Custom-made foot orthoses with a medial wedge have proven effective in improving comfort and correcting certain biomechanical alterations, even in asymptomatic individuals. The study described has two main objectives: * to validate the Italian version of the Foot Health Status Questionnaire (FHSQ), already validated in English and Spanish, by assessing its reliability and reproducibility as a tool to measure foot health. * through a pilot study, to analyze the effects of using specific professional footwear in healthcare workers with hyperpronation, evaluating perceived benefits in terms of pain reduction and postural improvement.

Interventions

DEVICEMedially wedged ortheses

3 month long wear of medially wedged ortheses. Ortheses have to be worn for 6 to 8 hours daily during work shifts.

Sponsors

ASST Gaetano Pini-CTO
CollaboratorOTHER
University of Milan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Healthworker (attendings, residents, OR nurses, ER nurses, therapists...) * Maximum age inferior to 65 y.o. at recruitment time * Partecipants stands from 60% to 80% of their working time * Uses mostly healthcare shoes while working * Hyperpronation condition * No other pathologic condition of the feet * Partecipants accept to wear medially wedged orthesis for at least 3 months * Signatures of consensus to join the study * Partecipants must be aware of the implication of the study

Exclusion criteria

* Other pathologic condition of the foot * Age superiore to 65 y.o. at the recruitment time

Design outcomes

Primary

MeasureTime frameDescription
FHSQ3 monthsAssessment and description of the clinical conditions of the partecipants

Secondary

MeasureTime frameDescription
GAITLABBaselineAssessment of the partecipants' foot condition (calcaneovalgus foot) while wearing and not the professional footwear.

Countries

Italy

Contacts

Primary ContactAlessandra Menon, PhD
ale.menon@me.com+393498694424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026