Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Milan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Other pathologic condition of the foot

Age superiore to 65 y.o. at the recruitment time

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Vibram shoe sampleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

FHSQ

Assessment and description of the clinical conditions of the partecipants

Time frame
3 months

Secondary outcomes

1

GAITLAB

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

Time frame
Baseline
2

GAITLAB

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

Time frame
Baseline
3

GAITLAB

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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University of Milan

Lead sponsor

ASST Gaetano Pini-CTO

Collaborator