Clinical trial NCT07000838: Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation
Official title: Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperpronation
Overpronation
Pes Planus
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: ASST Gaetano Pini-CTO
First posted: 2025-06-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: FHSQ
timeFrame: 3 months
Secondary outcomes:
measure: GAITLAB
timeFrame: Baseline
measure: GAITLAB
timeFrame: Baseline
measure: GAITLAB
timeFrame: Baseline
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ASST Gaetano Pini-CTO
Study officials:
References:
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