Hallux ValgusM-FirstNCT07653828
Evaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application
A study testing Hallux valgus surgery, Questionnaires and Physiotheray sessions in people with Hallux Valgus, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Hallux valgus is the most common forefoot deformity and primarily affects women. Surgical treatment involves an osteotomy of the first metatarsal to reduce the M1-M2 angle. Often, an osteotomy of the first phalanx of the big toe is performed in conjunction to reduce the M1-P1 angle. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Hallux valgus surgery, Questionnaires and Physiotheray sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2021to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 85 years,
- Patient, male or female, undergoing surgery for unilateral and isolated Hallux valgus with procedure of the 1st ray,
- First-line surgery,
- Persistent mobility of the metatarsophalangeal joint of the hallux,
- Patient in possession of a smartphone or tablet,
- Patient affiliated with or beneficiary of a social security scheme,
- Patient who has signed the free and informed consent.
Who cannot join
- Patient not having a smartphone or tablet,
- Rheumatoid foot,
- Hallux rigidus/MTP1 osteoarthritis,
- Gestures on the lateral rays
- Surgical or traumatic history influencing MTP1 mobility.
- Minors
- Adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative;
- Pregnant, breastfeeding or parturient woman; - Hospitalized without consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Clinique de l'Union
Saint-Jean, 31240
François LINTZ, Dr, 0033561378797, francois.lintz@clinique-union.fr
About this study
Hallux valgus is the most common forefoot deformity and primarily affects women. Surgical treatment involves an osteotomy of the first metatarsal to reduce the M1-M2 angle. Often, an osteotomy of the first phalanx of the big toe is performed in conjunction to reduce the M1-P1 angle.
Once the deformity has been corrected, the second objective is to restore the foot's function, particularly mobility and plantar flexion strength. To achieve this, rehabilitation is prescribed, but inconsistently due to the lack of clear guidelines and limited patient participation, especially outside of the physiotherapist's scheduled appointments.
Read more
Continuous passive range of motion exercises can accelerate the return to standard footwear and normal joint mobility. This study is based on the hypothesis that an application connected with rehabilitation exercises to be done outside of sessions with a physiotherapist reproduces this mechanism of continuous passive mobility. In this context, it is hoped that patients benefiting from self-rehabilitation of the foot via the connected application, in addition to traditional care with a physiotherapist, will achieve better postoperative mobility of the metatarsophalangeal joint of the hallux compared to traditional care with a physiotherapist in patients undergoing hallux valgus surgery, with an isolated procedure on the first ray.
The main objective is to compare the mobility of the metatarsophalangeal joint of the hallux 6 months after an operation for isolated hallux valgus by osteotomy in patients benefiting from optimized rehabilitation with a physiotherapist using a connected application compared to patients receiving standard care with a physiotherapist.
- Conditions
- Hallux Valgus
- Being tested
- Hallux valgus surgery, Questionnaires, Physiotheray sessions
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallux valgus surgeryProcedure or surgery
Primary surgery for hallux valgus
QuestionnairesOther
Different questionnaires : EFAS, EVA, EQ-5DL
Physiotheray sessionsOther
Physiotherapy sessions twice a week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patient with connected application | Experimental | After hallux valgus surgery, this group of patient has a connected application to do some exercises at home in addition to physiotherapy sessions Receives: Procedure: Hallux valgus surgery; Other: Questionnaires; Other: Physiotheray sessions |
| Patients without connected application | Placebo comparator | After hallux valgus surgery, this group of patient has only physiotherapy sessions. Receives: Procedure: Hallux valgus surgery; Other: Questionnaires; Other: Physiotheray sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility of the metatarsophalangeal joint of the hallux
Mobility of the metatarsophalangeal joint of the hallux is measured by the MTP1 angle (FD + FP), which will be clinically assessed using a goniometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start28 Jun 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653828
- Sponsor's protocol ID
- 2018-A03349-46
- Acronym
- M-First
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application
- ClinicalTrials.gov ID
- NCT07653828
- Acronym / sponsor ID
- M-First / 2018-A03349-46
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (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.
Hallux valgus is the most common forefoot deformity and primarily affects women. Surgical treatment involves an osteotomy of the first metatarsal to reduce the M1-M2 angle. Often, an osteotomy of the first phalanx of the big toe is performed in conjunction to reduce the M1-P1 angle.
Once the deformity has been corrected, the second objective is to restore the foot's function, particularly mobility and plantar flexion strength. To achieve this, rehabilitation is prescribed, but inconsistently due to the lack of clear guidelines and limited patient participation, especially outside of the physiotherapist's scheduled appointments.
Continuous passive range of motion exercises can accelerate the return to standard footwear and normal joint mobility. This study is based on the hypothesis that an application connected with rehabilitation exercises to be done outside of sessions with a physiotherapist reproduces this mechanism of continuous passive mobility. In this context, it is hoped that patients benefiting from self-rehabilitation of the foot via the connected application, in addition to traditional care with a physiotherapist, will achieve better postoperative mobility of the metatarsophalangeal joint of the hallux compared to traditional care with a physiotherapist in patients undergoing hallux valgus surgery, with an isolated procedure on the first ray.
The main objective is to compare the mobility of the metatarsophalangeal joint of the hallux 6 months after an operation for isolated hallux valgus by osteotomy in patients benefiting from optimized rehabilitation with a physiotherapist using a connected application compared to patients receiving standard care with a physiotherapist.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with connected application | Experimental | Procedure: Hallux valgus surgery, Other: Questionnaires, Other: Physiotheray sessionsAfter hallux valgus surgery, this group of patient has a connected application to do some exercises at home in addition to physiotherapy sessions |
| Patients without connected application | Placebo comparator | Procedure: Hallux valgus surgery, Other: Questionnaires, Other: Physiotheray sessionsAfter hallux valgus surgery, this group of patient has only physiotherapy sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years and < 85 years,
- Patient, male or female, undergoing surgery for unilateral and isolated Hallux valgus with procedure of the 1st ray,
- First-line surgery,
- Persistent mobility of the metatarsophalangeal joint of the hallux,
- Patient in possession of a smartphone or tablet,
Key exclusion criteria (8 listed)
- Patient not having a smartphone or tablet,
- Rheumatoid foot,
- Hallux rigidus/MTP1 osteoarthritis,
- Gestures on the lateral rays
- Surgical or traumatic history influencing MTP1 mobility.
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 |
|---|---|---|
| Hallux valgus surgeryPrimary surgery for hallux valgus | Procedure or surgery | Patient with connected application, Patients without connected application |
| QuestionnairesDifferent questionnaires : EFAS, EVA, EQ-5DL | Other | Patient with connected application, Patients without connected application |
| Physiotheray sessionsPhysiotherapy sessions twice a week for 10 weeks. | Other | Patient with connected application, Patients without connected application |
Primary outcome
Mobility of the metatarsophalangeal joint of the hallux
Time frame: 6 months
Mobility of the metatarsophalangeal joint of the hallux is measured by the MTP1 angle (FD + FP), which will be clinically assessed using a goniometer.
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 16 Jul 2026.
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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.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hallux valgus surgery, Questionnaires and Physiotheray sessions in people with Hallux Valgus, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 7 inclusion and 8 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 16 Jul 2026. 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 France. 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. Some participants in this study may receive a placebo. 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 Jean-François Oudet (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility of the metatarsophalangeal joint of the hallux (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.