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

Обзор

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.

Вмешательства

• Процедура Hallux valgus surgery
  Primary surgery for hallux valgus
• Другое Questionnaires
  Different questionnaires : EFAS, EVA, EQ-5DL
• Другое Physiotheray sessions
  Physiotherapy sessions twice a week for 10 weeks.

Первичные конечные точки

• Mobility of the metatarsophalangeal joint of the hallux [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Clinique de l'Union — Saint-Jean

Идентификаторы

NCT: NCT07653828 · 2018-A03349-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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