Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation

NCT07000838 | Recruiting

• 1 other identifier: ORTHOPROnew
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpronation; Overpronation; Pes Planus

Outcome Measures

Primary Outcomes (1)

• FHSQ

  Assessment and description of the clinical conditions of the partecipants

  3 months

Secondary Outcomes (3)

• GAITLAB

  Baseline

• GAITLAB

  Baseline

• GAITLAB

  Baseline

Study Arms (1)

Vibram shoe sample

EXPERIMENTAL

To be recruited the partecipants of the study have been visited and their overpronation foot condition has been assessed. Then they will answer the FHSQ at T0. They will have to wear medially wedged ortheses for the duration for 3 months and then be re-assessed by a second evaluation using the FHSQ. Using GAITLAB (from BTS S.p.a) the partecipants' foot condition (calcaneovalgus foot) will be assessed while wearing and not the professional footwear.

Device: Medially wedged ortheses

Interventions

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.

Also known as: Wedged ortheses

Vibram shoe sample

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: All genders are eligible to partecipate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other pathologic condition of the foot
• Age superiore to 65 y.o. at the recruitment time

Sponsors & Collaborators

• University of Milan: lead
• ASST Gaetano Pini-CTO: collaborator

Study Sites (1)

ASST Gaetano Pini-CTO

Milan, Italy, 20122, Italy

RECRUITING

Related Publications (22)

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  PMID: 20465855 BACKGROUND

• Landorf KB, Twyford GN, Cotchett MP, Whittaker GA. Revised minimal important difference values for the visual analogue scale and Foot Health Status Questionnaire when used for plantar heel pain. J Foot Ankle Res. 2024 Dec;17(4):e70021. doi: 10.1002/jfa2.70021.

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  PMID: 21791454 BACKGROUND

• Menz HB, Auhl M, Tan JM, Levinger P, Roddy E, Munteanu SE. Effectiveness of Foot Orthoses Versus Rocker-Sole Footwear for First Metatarsophalangeal Joint Osteoarthritis: Randomized Trial. Arthritis Care Res (Hoboken). 2016 May;68(5):581-9. doi: 10.1002/acr.22750.

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• Chuter VH, Searle A, Spink MJ. Flip-flop footwear with a moulded foot-bed for the treatment of foot pain: a randomised controlled trial. BMC Musculoskelet Disord. 2016 Nov 11;17(1):468. doi: 10.1186/s12891-016-1327-x.

  PMID: 27835963 BACKGROUND

• Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305.

  PMID: 16801514 BACKGROUND

• Riskowski JL, Hagedorn TJ, Hannan MT. Measures of foot function, foot health, and foot pain: American Academy of Orthopedic Surgeons Lower Limb Outcomes Assessment: Foot and Ankle Module (AAOS-FAM), Bristol Foot Score (BFS), Revised Foot Function Index (FFI-R), Foot Health Status Questionnaire (FHSQ), Manchester Foot Pain and Disability Index (MFPDI), Podiatric Health Questionnaire (PHQ), and Rowan Foot Pain Assessment (ROFPAQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S229-39. doi: 10.1002/acr.20554. No abstract available.

  PMID: 22588747 BACKGROUND

• Cuesta-Vargas A, Bennett P, Jimenez-Cebrian AM, Labajos-Manzanares MT. The psychometric properties of the Spanish version of the Foot Health Status Questionnaire. Qual Life Res. 2013 Sep;22(7):1739-43. doi: 10.1007/s11136-012-0287-3. Epub 2012 Oct 12.

  PMID: 23065118 BACKGROUND

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  PMID: 11124735 BACKGROUND

• Vaughan CL, Davis BL, O'Connor JC. Dynamics of human gait. Kiboho Publishers (Cape Town, South Africa). Second Edition. , 1999.

  BACKGROUND

• Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.

  PMID: 9770933 BACKGROUND

• Chiu MC, Wang MJ. Professional footwear evaluation for clinical nurses. Appl Ergon. 2007 Mar;38(2):133-41. doi: 10.1016/j.apergo.2006.03.012.

  PMID: 16765904 BACKGROUND

• Anderson J, Williams AE, Nester C. An explorative qualitative study to determine the footwear needs of workers in standing environments. J Foot Ankle Res. 2017 Aug 30;10:41. doi: 10.1186/s13047-017-0223-4. eCollection 2017.

  PMID: 28861123 BACKGROUND

• Tarrade T, Doucet F, Saint-Lo N, Llari M, Behr M. Are custom-made foot orthoses of any interest on the treatment of foot pain for prolonged standing workers? Appl Ergon. 2019 Oct;80:130-135. doi: 10.1016/j.apergo.2019.05.013. Epub 2019 May 28.

  PMID: 31280796 BACKGROUND

• Telfer S, Abbott M, Steultjens M, Rafferty D, Woodburn J. Dose-response effects of customised foot orthoses on lower limb muscle activity and plantar pressures in pronated foot type. Gait Posture. 2013 Jul;38(3):443-9. doi: 10.1016/j.gaitpost.2013.01.012. Epub 2013 Feb 5.

  PMID: 23391752 BACKGROUND

• Braga UM, Mendonca LD, Mascarenhas RO, Alves COA, Filho RGT, Resende RA. Effects of medially wedged insoles on the biomechanics of the lower limbs of runners with excessive foot pronation and foot varus alignment. Gait Posture. 2019 Oct;74:242-249. doi: 10.1016/j.gaitpost.2019.09.023. Epub 2019 Sep 23.

  PMID: 31574408 BACKGROUND

• Bonifacio D, Richards J, Selfe J, Curran S, Trede R. Influence and benefits of foot orthoses on kinematics, kinetics and muscle activation during step descent task. Gait Posture. 2018 Sep;65:106-111. doi: 10.1016/j.gaitpost.2018.07.041. Epub 2018 Jul 24.

  PMID: 30558915 BACKGROUND

• Menz HB, Auhl M, Ristevski S, Frescos N, Munteanu SE. Effectiveness of off-the-shelf, extra-depth footwear in reducing foot pain in older people: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2015 Apr;70(4):511-7. doi: 10.1093/gerona/glu169. Epub 2014 Sep 9.

  PMID: 25205761 BACKGROUND

• Thomas MJ, Roddy E, Zhang W, Menz HB, Hannan MT, Peat GM. The population prevalence of foot and ankle pain in middle and old age: a systematic review. Pain. 2011 Dec;152(12):2870-2880. doi: 10.1016/j.pain.2011.09.019. Epub 2011 Oct 21.

  PMID: 22019150 BACKGROUND

• Menz HB, Dufour AB, Riskowski JL, Hillstrom HJ, Hannan MT. Association of planus foot posture and pronated foot function with foot pain: the Framingham foot study. Arthritis Care Res (Hoboken). 2013 Dec;65(12):1991-9. doi: 10.1002/acr.22079.

  PMID: 23861176 BACKGROUND

• Sanchez-Rodriguez R, Valle-Estevez S, Fraile-Garcia PA, Martinez-Nova A, Gomez-Martin B, Escamilla-Martinez E. Modification of Pronated Foot Posture after a Program of Therapeutic Exercises. Int J Environ Res Public Health. 2020 Nov 13;17(22):8406. doi: 10.3390/ijerph17228406.

  PMID: 33202893 BACKGROUND

• Golightly YM, Hannan MT, Dufour AB, Hillstrom HJ, Jordan JM. Foot disorders associated with overpronated and oversupinated foot function: the Johnston County osteoarthritis project. Foot Ankle Int. 2014 Nov;35(11):1159-65. doi: 10.1177/1071100714543907. Epub 2014 Jul 18.

  PMID: 25037712 BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Alessandra Menon, PhD

CONTACT

+393498694424; ale.menon@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: June 3, 2025
• Study Start: May 9, 2025
• Primary Completion: May 5, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-04

Locations

IT (1)