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NCT Number: NCT07000838

Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation

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.

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Key information

Conditions

Hyperpronation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Overpronation Pes Planus Talipes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Gaetano Pini-CTO

Milan, Italy, 20122

Location status: Recruiting

Location contact

Alessandra Menon

CONTACT

Alessandra Menon, PhD

CONTACT

[email protected]

3498694424

Pietro Simone Randelli, Prof., MD

PRINCIPAL_INVESTIGATOR

Silvia De Martinis, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medially wedged ortheses

Device

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

Other names: Wedged ortheses

Primary outcomes

  1. FHSQ

    Time frame: 3 months

    Assessment and description of the clinical conditions of the partecipants

Secondary outcomes

  1. GAITLAB

    Time frame: Baseline

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

  2. GAITLAB

    Time frame: Baseline

    Assessment of medial plantar support, performed in a static position using a baropodometric platform.

  3. GAITLAB

    Time frame: Baseline

    Assessment of pressure on the metatarsal heads, performed in a static position using a baropodometric platform, barefoot.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Menon, PhD

CONTACT

[email protected]

+393498694424

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • ASST Gaetano Pini-CTO

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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