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临床试验/NCT02748759
NCT02748759已完成不适用

Early Mobilization of Knee Joint After ACL Reconstructive Surgery Comparing Continuous Passive Motion Versus Manual Passive Mobilization

Jesús Montesinos Muñoz1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年5月1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
15
试验地点
1
主要终点
Knee Range of Motion (ROM) angle

研究概览

简要总结

Anterior Cruciate Ligament (ACL) injuries by trauma are a prevalent pathology. In the USA, about 200.000 injuries are estimated per year, half of which implicate a total rupture of the ligament. Data indicates that the number of ACL injuries is increasing in young athletes and presents a common problem, especially people playing agility sports.

One of the most widely used methods for the post-surgical mobilization after ACL is the use of Continuous Passive Motion (CPM) devices. These machines are meant to drain residual fluid from the articulation and maintain the mobility of the joint and muscles in the knee. Even though studies show that, an early mobilization after surgery is beneficial to the rehabilitation of the knee joint, recent studies are questioning the efficiency of the CPM when compared with the goal of application. While literature suggests that efficacy of CPM are related with the magnitude of knee flexion and the Range of Motion (ROM) achieved some studies show that the range of motion measured by the CPM is considerably less than the actual ROM.

As other therapy that provides an effective mobilization of the knee joint, the Specific Manual Physical Therapy method (Kaltenborn method) takes in account the physiological combination of rotation and gliding of the two joint surfaces. This technique mobilizes the femorotibial joint by controlling the tibial plateau anteroposterior during flexion and posteroanterior during extension of the knee. Therefore, in the past 30 years there are not studies comparing ROM measurements obtained with CPM and manual physical therapy methods.

It is hypothesized that the benefits of the early passive mobilization after ACL reconstructive surgery are diminished by the limited efficacy of currently used CPM devices. The aim of our study was to determine the range of motion achieved with the passive mobilization using a CPM device compared with a manual method (Kaltenborn method) and to assess that ROM measurements provided by the CPM correlates the real ROM.

研究设计

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

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Rupture of Anterior cruciate ligament
  • •Ligamentoplasty with partial meniscectomy when necessary using arthroscopy technique

排除标准

  • •Patients operated after three weeks post-injury because of greater risk of arthrofibrosis
  • •Patients who had medical complications during surgery
  • •Patients unable to understand the study protocol and those unwilling to give informed consent

研究组 & 干预措施

EXP 1: Manual mobilization / CPM

Active Comparator

Patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist. After a pause of 5 minutes, the patient was collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension.

干预措施: CPM (Device)

EXP 1: Manual mobilization / CPM

Active Comparator

Patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist. After a pause of 5 minutes, the patient was collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension.

干预措施: Manual mobilization (Other)

EXP 2: CPM / Manual mobilization

Active Comparator

Patients were collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension. After a pause of 5 minutes, patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist.

干预措施: CPM (Device)

EXP 2: CPM / Manual mobilization

Active Comparator

Patients were collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension. After a pause of 5 minutes, patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist.

干预措施: Manual mobilization (Other)

结局指标

主要结局

Knee Range of Motion (ROM) angle

时间窗: Fifteen hours after surgery

Maximum knee flexion angle minus the maximum knee extension angle obtained from 15 repetitions of flexo-extension. Measurements were obtained by CPM device and an external goniometer

Knee maximum flexion

时间窗: Fifteen hours after surgery

Maximum knee flexion obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer

Knee maximum extension

时间窗: Fifteen hours after surgery

Maximum knee extension obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer

次要结局

  • Pain(Fifteen hours after surgery)
  • Fluid volumen drained (ml)(Fifteen hours after surgery)
  • Time (seconds)(Fifteen hours after surgery)

研究者

发起方
Jesús Montesinos Muñoz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jesús Montesinos Muñoz

Medical Doctor

Althaia Xarxa Assistencial Universitària de Manresa

研究点 (1)

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