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临床试验/NCT07653828
NCT07653828招募中不适用

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

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2021年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
188
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.
  • Adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative;
  • Pregnant, breastfeeding or parturient woman; - Hospitalized without consent

研究组 & 干预措施

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

干预措施: Hallux valgus surgery (Procedure)

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

干预措施: Questionnaires (Other)

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

干预措施: Physiotheray sessions (Other)

Patients without connected application

Placebo Comparator

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

干预措施: Hallux valgus surgery (Procedure)

Patients without connected application

Placebo Comparator

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

干预措施: Questionnaires (Other)

Patients without connected application

Placebo Comparator

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

干预措施: Physiotheray sessions (Other)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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