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

NCT07653828 | Recruiting

• 1 other identifier: 2018-A03349-46
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hallux Valgus

Outcome Measures

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.

  6 months

Study Arms (2)

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

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.

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

Interventions

Hallux valgus surgery PROCEDURE

Primary surgery for hallux valgus

Patient with connected application; Patients without connected application

Questionnaires OTHER

Different questionnaires : EFAS, EVA, EQ-5DL

Patient with connected application; Patients without connected application

Physiotheray sessions OTHER

Physiotherapy sessions twice a week for 10 weeks.

Patient with connected application; Patients without connected application

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Clinique de l'Union

Saint-Jean, 31240, France

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jean-François Oudet

CONTACT

0033683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 28, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)