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RecruitingNCT07653828M-FirstUpdated Jul 16, 2026

Evaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application

An interventional study of Hallux valgus surgery and Questionnaires in Hallux Valgus, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Jun 2021, registered Jun 2026).
  • Started Jun 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hallux Valgus

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03

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 188 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 18 years and \< 85 years,
  • Patient, male or female, undergoing surgery for unilateral and isolated Hallux valgus with procedure of the 1st ray,
  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (estimated)

Study arms

  • Experimental
    Patient with connected application

    After hallux valgus surgery, this group of patient has a connected application to do some exercises at home in addition to physiotherapy sessions

    Procedure: Hallux valgus surgery · Other: Questionnaires · Other: Physiotheray sessions

  • Placebo comparator
    Patients without connected application

    After hallux valgus surgery, this group of patient has only physiotherapy sessions.

    Procedure: Hallux valgus surgery · Other: Questionnaires · Other: Physiotheray sessions

Interventions

  • ProcedureHallux valgus surgery

    Primary surgery for hallux valgus

  • OtherQuestionnaires

    Different questionnaires : EFAS, EVA, EQ-5DL

  • OtherPhysiotheray sessions

    Physiotherapy sessions twice a week for 10 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07653828
Responsible party
Sponsor
First posted
Jun 17, 2026
Start date
Jun 28, 2021
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0033683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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