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临床试验/NCT07553013
NCT07553013已完成不适用

Bénéfices de la Synchronisation Des Stimulations Proprioceptives Fonctionnelles (FPS) Avec la thérapie Par Mouvements Passifs Continus (CPM) après Reconstruction du Ligament croisé antérieur (RLCA).

Universite Cote d'Azur1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Active and passive range of motion

研究概览

简要总结

The goal of this trial is to test if functional proprioceptive stimulations combined with continuous passive movement is more efficient than continuous passive movement alone to recover knee joint mobility after anterior cruciate ligament reconstruction in adults. It will also learn about the influence of functional proprioceptive stimulations on pain and pain medication. The main questions it aims to answer are:

  • Does functional proprioceptive stimulations combined with continuous passive movement increase knee joint mobility more than continuous passive movement alone?
  • Does functional proprioceptive stimulations combined with continuous passive movement reduce perceived pain and pain medication use more than continuous passive movement alone? Researchers will compare functional proprioceptive stimulations combined with continuous passive movement to continuous passive movement alone to see if functional proprioceptive stimulations combined with continuous passive movement is more efficient than continuous passive movement alone.

Participants will:

  • Follow a supervised rehabilitation intervention comprising functional proprioceptive stimulations combined with continuous passive movement or continuous passive movement alone during five days a week for 2 weeks
  • Attend the clinic five days a week for 2 weeks for rehabilitation, checkups and assessments

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • participants with isolated ACL rupture
  • ACL reconstructed with a four-stranded semitendinosus or ex-tra-articular tenodesis autograft
  • enrollment in the rehabilitation program between the fourth and seventh postoperative day

排除标准

  • previous ligament reconstruction of the involved knee, reconstruction using quadriceps or patellar tendon autograft
  • presence of major neurological or musculoskeletal disorders (e.g., multiple trauma, Parkinson's disease, cerebral palsy, stroke, Alzheimer's disease, dementia…)
  • presence of cognitive impairment (i.e., Mini Mental State Examination score < 18)
  • body mass index greater than 35 kg/m².

研究组 & 干预措施

functional proprioceptive stimulations combined with continuous passive movement

Experimental

干预措施: functional proprioceptive stimulations combined with continuous passive movement (Device)

functional proprioceptive stimulations combined with continuous passive movement

Experimental

干预措施: continuous passive movement (Device)

continuous passive movement

Active Comparator

干预措施: continuous passive movement (Device)

结局指标

主要结局

Active and passive range of motion

时间窗: From enrollment to the end of intervention at 2 weeks

Active and passive range of motion of the knee joint (in degrees; °) will be assessed with a 30-cm long manual goniometer at the end of the first session, the fifth and the last rehabilitation session of the 2 weeks intervention.

次要结局

  • Perceived pain and pain medication(Throughout the 2 weeks intervention)

研究者

发起方
Universite Cote d'Azur
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serge Colson

Professor

Universite Cote d'Azur

研究点 (1)

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