Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation
NCT ID: NCT07000838
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2025-05-09
2026-09-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vibram shoe sample
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.
Medially wedged ortheses
3 month long wear of medially wedged ortheses. Ortheses have to be worn for 6 to 8 hours daily during work shifts.
Interventions
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Medially wedged ortheses
3 month long wear of medially wedged ortheses. Ortheses have to be worn for 6 to 8 hours daily during work shifts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Age superiore to 65 y.o. at the recruitment time
18 Years
65 Years
ALL
No
Sponsors
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ASST Gaetano Pini-CTO
OTHER
University of Milan
OTHER
Responsible Party
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Pietro Randelli, MD
Prof., MD
Locations
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ASST Gaetano Pini-CTO
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Alessandra Menon
Role: backup
References
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Landorf KB, Radford JA, Hudson S. Minimal Important Difference (MID) of two commonly used outcome measures for foot problems. J Foot Ankle Res. 2010 May 14;3:7. doi: 10.1186/1757-1146-3-7.
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.
Munteanu SE, Zammit GV, Menz HB, Landorf KB, Handley CJ, Elzarka A, Deluca J. Effectiveness of intra-articular hyaluronan (Synvisc, hylan G-F 20) for the treatment of first metatarsophalangeal joint osteoarthritis: a randomised placebo-controlled trial. Ann Rheum Dis. 2011 Oct;70(10):1838-41. doi: 10.1136/ard.2011.153049. Epub 2011 Jul 25.
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.
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.
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.
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.
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.
Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
Vaughan CL, Davis BL, O'Connor JC. Dynamics of human gait. Kiboho Publishers (Cape Town, South Africa). Second Edition. , 1999.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ORTHOPROnew
Identifier Type: -
Identifier Source: org_study_id
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