Medially wedged rubber insoles for healthcare workers with foot overpronation
Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation
This tests medially wedged rubber insoles to see if they reduce pain and improve posture in healthcare workers who have foot overpronation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT07000838 on ClinicalTrials.gov |
What this trial studies
The study first validates an Italian translation of the Foot Health Status Questionnaire (FHSQ) by measuring its reliability and reproducibility in Italian-speaking participants. In a pilot interventional phase, healthcare workers with hyperpronation will be fitted with medially wedged rubber insoles and asked to wear them during work for at least three months. Outcomes will include self-reported foot health, pain, and perceived postural changes measured with the validated FHSQ alongside clinical observation. The trial is conducted at ASST Gaetano Pini-CTO in Milan and targets workers who stand 60–80% of their shifts.
Who should consider this trial
Good fit: Ideal candidates are healthcare workers under 65 who stand most of their shift, have foot hyperpronation without other foot pathologies, and are willing to wear medially wedged insoles for at least three months.
Not a fit: Patients with other foot pathologies, those older than 65, or people who do not regularly wear healthcare footwear or cannot commit to wearing the insoles are less likely to benefit.
Why it matters
Potential benefit: If successful, participants may experience reduced foot pain and improved standing posture, and clinicians would have a validated Italian FHSQ to measure foot health outcomes.
How similar studies have performed: Previous studies of custom medial-wedge foot orthoses have shown improved comfort and biomechanical alignment, so this approach has supporting evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan, Italy
- ASST Gaetano Pini-CTO — Milan, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandra Menon, PhD
- Email: ale.menon@me.com
- Phone: +393498694424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.