Hallux ValgusPhase 1NCT05210127
Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgical Procedure
A Phase 1 study testing Scarf osteotomy for Hallux Valgus deformity in people with Hallux Valgus, run by Józef Piłsudski University of Physical Education.
Trial summary
The aim of the study is to identify the impact of CFS foot muscle training on time-space parameters, anthropometric parameters and bioelectrical activity (EMG) of the foot muscles during walking and to develop an algorithm for an effective therapeutic method in patients after hallux valgus correction. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Scarf osteotomy for Hallux Valgus deformity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- hallux valgus deformity
- surgical procedure
- voluntary consent to the study
Who cannot join
- lack of consent to research
- other deformation and operations of the foot
- pain after the surgery which prevents experimental procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgery
The aim of the study is to identify the impact of CFS foot muscle training on time-space parameters, anthropometric parameters and bioelectrical activity (EMG) of the foot muscles during walking and to develop an algorithm for an effective therapeutic method in patients after hallux valgus correction. Achieving the purpose of the research will contribute to the answer to the following research questions:
- Does the CFS therapy used significantly change the arch of the foot in HV patients compared to the control group?
- Does the CFS therapy used significantly improve gait characteristics after HV surgery in relation to the control group?
- Does muscle stimulation and the moment of their activation differ in groups in which different therapies have been used?
- Will the results of the questionnaires and scale be significantly different in both groups?
- Conditions
- Hallux Valgus
- Being tested
- Scarf osteotomy for Hallux Valgus deformity
- Keywords
- hallux valgus, core foot system, rehabilitation protocol
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scarf osteotomy for Hallux Valgus deformityProcedure or surgery
An experiment of foot muscle strength and activation, during gate phases after hallux valgus correction with the use of core foot system protocol
| Study group | Role | What they receive |
|---|---|---|
| After Scarf Osteotomy Group | Experimental | 30 participants after surgery Receives: Procedure: Scarf osteotomy for Hallux Valgus deformity |
| Without Scarf Osteotomy Group | Experimental | 30 participants without surgery Receives: Procedure: Scarf osteotomy for Hallux Valgus deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint
Orthopaedic Scale to describe function and problems with first metatarsophalangeal joint
Measured: 8 weeks
The 36-Item Short Form Survey (SF-36)
The SF-36 is often used as a measure of a person or population's quality of life (QOL)
Measured: 8 weeks
Zebris Medical System
The plantar pressure distribution measurement systems
Measured: 8 weeks
EMG test
Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle
Measured: 8 weeks
Podoscope test
A diagnostic device that allows the assessment of the sole of the foot while standing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210127
- Sponsor's protocol ID
- SKE 01-42/2021
- Status last verified
- Nov 2021
- First submitted
- 1 Dec 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baran M, Kolodziejski P, Kaczmarczyk K. Protocol: a randomized parallel-group study of women after hallux valgus correction surgery to compare the effects of "core foot system" training vs. traditional rehabilitation methods. Acta Bioeng Biomech. 2024 Feb 26;25(4):103-109. doi: 10.37190/abb-02332-2023-03. Print 2023 Dec 1.
PubMed 39072466
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT05210127
- Acronym / sponsor ID
- SKE 01-42/2021
- Conditions
- Hallux Valgus
- Keywords
- hallux valgus, core foot system, rehabilitation protocol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 27 Jan 2022 (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.
The aim of the study is to identify the impact of CFS foot muscle training on time-space parameters, anthropometric parameters and bioelectrical activity (EMG) of the foot muscles during walking and to develop an algorithm for an effective therapeutic method in patients after hallux valgus correction. Achieving the purpose of the research will contribute to the answer to the following research questions:
- Does the CFS therapy used significantly change the arch of the foot in HV patients compared to the control group?
- Does the CFS therapy used significantly improve gait characteristics after HV surgery in relation to the control group?
- Does muscle stimulation and the moment of their activation differ in groups in which different therapies have been used?
- Will the results of the questionnaires and scale be significantly different in both groups?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After Scarf Osteotomy Group | Experimental | Procedure: Scarf osteotomy for Hallux Valgus deformity30 participants after surgery |
| Without Scarf Osteotomy Group | Experimental | Procedure: Scarf osteotomy for Hallux Valgus deformity30 participants without surgery |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- hallux valgus deformity
- surgical procedure
- voluntary consent to the study
Key exclusion criteria (3 listed)
- lack of consent to research
- other deformation and operations of the foot
- pain after the surgery which prevents experimental procedure
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 |
|---|---|---|
| Scarf osteotomy for Hallux Valgus deformityAn experiment of foot muscle strength and activation, during gate phases after hallux valgus correction with the use of core foot system protocol | Procedure or surgery | After Scarf Osteotomy Group, Without Scarf Osteotomy Group |
Primary outcome
American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint
Time frame: 8 weeks
Orthopaedic Scale to describe function and problems with first metatarsophalangeal joint
The 36-Item Short Form Survey (SF-36)
Time frame: 8 weeks
The SF-36 is often used as a measure of a person or population's quality of life (QOL)
Zebris Medical System
Time frame: 8 weeks
The plantar pressure distribution measurement systems
EMG test
Time frame: 8 weeks
Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle
Podoscope test
Time frame: 8 weeks
A diagnostic device that allows the assessment of the sole of the foot while standing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 39072466Baran M, Kolodziejski P, Kaczmarczyk K. Protocol: a randomized parallel-group study of women after hallux valgus correction surgery to compare the effects of "core foot system" training vs. traditional rehabilitation methods. Acta Bioeng Biomech. 2024 Feb 26;25(4):103-109. doi: 10.37190/abb-02332-2023-03. Print 2023 Dec 1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Scarf osteotomy for Hallux Valgus deformity in people with Hallux Valgus, run by Józef Piłsudski University of Physical Education.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mateusz Baran (500220003, mateusz.baran.93@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopaedic Foot and Ankle Scale for first metatarsophalangeal joint (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 NCT05210127, which also lists 1 linked publication.
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 27 Jan 2022; AzTrials last refreshed its copy on 31 Oct 2026.