Minimal Important Difference (MID) of two commonly used outcome measures for foot problems.
Karl B Landorf, Joel A Radford, Susie Hudson
https://pubmed.ncbi.nlm.nih.gov/20465855Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07000838
Evaluation of the Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation
Led by University of Milan · Updated on 2025-06-03
52
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
Sponsors
U
University of Milan
Lead Sponsor
A
ASST Gaetano Pini-CTO
Collaborating Sponsor
AI-Summary
What this Trial Is About
Foot hyperpronation is a common condition that affects posture and can cause pain, foot deformities like hallux valgus, and muscle problems. It is especially important to study in adults who stand for long periods, such as healthcare workers. This research aims to validate the Italian version of the Foot Health Status Questionnaire (FHSQ) to measure foot health reliably and to pilot test the effects of using specific professional footwear in healthcare workers with hyperpronation, focusing on pain relief and posture improvement. Participants diagnosed with foot overpronation will wear medially wedged orthoses for three months, using them for 6 to 8 hours daily during work shifts. The study will assess foot condition both with and without the professional footwear using GAITLAB technology. They will complete the FHSQ questionnaire before and after the intervention to evaluate changes. Participants will be assessed at the start and after three months using the FHSQ to measure foot health. GAITLAB assessments will monitor foot biomechanics at baseline. The study tracks pain, posture, and foot condition improvements. The total study duration per participant involves a three-month period of wearing the orthoses with evaluations at the beginning and end. The research is sponsored by the University of Milan.
CONDITIONS
Brief Title
Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Healthcare worker (including attendings, residents, OR nurses, ER nurses, therapists)
- Maximum age under 65 years at recruitment
- Stands for 60% to 80% of working time
- Uses mostly healthcare shoes while working
- Diagnosed with foot hyperpronation
- No other pathological foot conditions
- Willing to wear medially wedged orthoses for at least 3 months
- Signed consent to join the study
- Aware of the study implications
You will not qualify if you...
- Having other pathological foot conditions
- Age over 65 years at recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 3 months
Participants wear medially wedged orthoses for 3 months, 6 to 8 hours daily during work shifts, to correct foot overpronation.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
ASST Gaetano Pini-CTO
Milan, Italy, Italy, 20122
Actively Recruiting
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Research Team
A
Alessandra Menon, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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D E Beaton, C Bombardier, F Guillemin...
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P J Bennett, C Patterson, S Wearing...
https://pubmed.ncbi.nlm.nih.gov/9770933