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NCT Number: NCT07653828

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

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,
  • 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.

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

Treatment and study plan

Hallux valgus surgery

Procedure

Primary surgery for hallux valgus

questionnaires

Other

Different questionnaires : EFAS, EVA, EQ-5DL

Physiotheray sessions

Other

Physiotherapy sessions twice a week for 10 weeks.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François Oudet

CONTACT

[email protected]

0033683346567

Marie-Hélène Barba

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: M-First

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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