NCT07653828 Evaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application
| NCT ID | NCT07653828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche |
| Condition | Hallux Valgus |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2021-06-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2021-06-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07653828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Hallux Valgus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07653828 currently recruiting?
Yes, NCT07653828 is actively recruiting participants. Contact the research team at jf.oudet@ecten.eu for enrollment information.
Where is the NCT07653828 trial being conducted?
This trial is being conducted at Saint-Jean, France.
Who is sponsoring the NCT07653828 clinical trial?
NCT07653828 is sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. The trial plans to enroll 188 participants.