Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation

Not Applicable

Recruiting

• Conditions: Hyperpronation; Overpronation; Pes Planus

• Registration Number: NCT07000838
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-21
• Study Start: 2025-05-09
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-05-05
• Study Completion: 2026-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
FHSQ	3 months	Assessment and description of the clinical conditions of the partecipants

Secondary Outcome Measures

Name	Time	Method
GAITLAB	Baseline	Assessment of pressure on the metatarsal heads, performed in a static position using a baropodometric platform, barefoot.

Trial Locations

Locations (1)

ASST Gaetano Pini-CTO; 🇮🇹 Milan, Italy