HyperpronationNCT07000838
Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation
A study testing Medially wedged ortheses in people with Hyperpronation and Overpronation, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperpronation, Overpronation, Pes Planus
- What is being tested?
- Medially wedged ortheses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2025to 18 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Other pathologic condition of the foot
- Age superiore to 65 y.o. at the recruitment time
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Gaetano Pini-CTO
Milan, Italy, 20122
Alessandra Menon, PhD, 3498694424, ale.menon@me.com
Alessandra Menon
About this study
Official title: Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation
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
- Being tested
- Medially wedged ortheses
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medially wedged orthesesDevice
Also called Wedged ortheses
3 month long wear of medially wedged ortheses. Ortheses have to be worn for 6 to 8 hours daily during work shifts.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Medially wedged ortheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
FHSQ
Assessment and description of the clinical conditions of the partecipants
Measured: 3 months
Secondary outcomes (3)
GAITLAB
Assessment of the partecipants' foot condition (calcaneovalgus foot) while wearing and not the professional footwear.
Measured: Baseline
GAITLAB
Assessment of medial plantar support, performed in a static position using a baropodometric platform.
Measured: Baseline
GAITLAB
Assessment of pressure on the metatarsal heads, performed in a static position using a baropodometric platform, barefoot.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start9 May 2025
- Primary completion5 May 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for HyperpronationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Gaetano Pini-CTO
- Responsible party
- Principal investigator, Pietro Randelli, MD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000838
- Sponsor's protocol ID
- ORTHOPROnew
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision not already taken
Publications
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.
PubMed 20465855Landorf 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.
PubMed 39682003Munteanu 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.
PubMed 21791454Menz 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.
PubMed 26638878Chuter 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.
PubMed 27835963Landorf 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.
PubMed 16801514Riskowski 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.
PubMed 22588747Cuesta-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.
PubMed 23065118Beaton 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.
PubMed 11124735Vaughan 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.
PubMed 9770933Chiu 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.
PubMed 16765904Anderson 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.
PubMed 28861123Tarrade 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.
PubMed 31280796Telfer 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.
PubMed 23391752
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation
- ClinicalTrials.gov ID
- NCT07000838
- Acronym / sponsor ID
- ORTHOPROnew
- Conditions
- Hyperpronation, Overpronation, Pes Planus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- ASST Gaetano Pini-CTO
- Study start
- 9 May 2025 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibram shoe sample | Experimental | Device: Medially wedged orthesesTo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Other pathologic condition of the foot
- Age superiore to 65 y.o. at the recruitment time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medially wedged orthesesAlso: Wedged ortheses3 month long wear of medially wedged ortheses. Ortheses have to be worn for 6 to 8 hours daily during work shifts. | Device | Vibram shoe sample |
Primary outcome
FHSQ
Time frame: 3 months
Assessment and description of the clinical conditions of the partecipants
3 secondary outcomes
GAITLAB
Time frame: Baseline
GAITLAB
Time frame: Baseline
GAITLAB
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Results publication: PubMed 20465855Landorf 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.
- Results publication: PubMed 39682003Landorf 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.
- Results publication: PubMed 21791454Munteanu 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.
- Results publication: PubMed 26638878Menz 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.
- Results publication: PubMed 27835963Chuter 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.
- Results publication: PubMed 16801514Landorf 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.
- Results publication: PubMed 22588747Riskowski 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.
- Results publication: PubMed 23065118Cuesta-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.
- Results publication: PubMed 11124735Beaton 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.
- Results publicationVaughan CL, Davis BL, O'Connor JC. Dynamics of human gait. Kiboho Publishers (Cape Town, South Africa). Second Edition. , 1999.
- Results publication: PubMed 9770933Bennett 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.
- Results publication: PubMed 16765904Chiu 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.
- Individual participant dataSharing planned: Undecided. Decision not already taken
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medially wedged ortheses in people with Hyperpronation and Overpronation, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Menon, PhD (+393498694424, ale.menon@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FHSQ (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000838, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.