跳至主要内容
临床试验/NCT04939389
NCT04939389已完成不适用

Comparing a Sensor for Movement Assessment With Traditional Clinical Assessment Methods in Patients After Knee Surgery.

crossklinik AG2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Tilt angle of the leg in degrees during passive movement of the leg (knee joint)

研究概览

简要总结

Eight parameters measurable by the sensor "Orthelligent Pro" are compared with traditional measurements based on a goniometer or video taping. The aim is to inform potential users about the distribution of the differences they have to expect when moving from traditional measurement methods to the new sensor.

Patients will perform eight corresponding movement exercises at a single study visit.

详细描述

In patients suffering from musculo-skeletal disorders, the restoration of full functioning is an important goal of many interventions. Assessment of functioning is often based on corresponding tests. If functioning is related to specific movement patterns, accelerometers and similar sensors are promising to allow a simple and objective assessment, and may replace traditional assessment methods, e.g. based on measurements with the goniometer. Corresponding products tend to enter the market and face clinicians and patients with the question, to which degree they are reliable and comparable with the traditional assessment methods.

Recently, a sensor named "Orthelligent Pro" has been released by the medical device company OPED and is today commercially available. The sensor - to be attached to the knee of a subject - offers the opportunity to assess several parameters related to movement patterns in the lower extremities that are of relevance in the rehabilitation process of orthopedic patients.

The aim of the current project is to inform potential users of this sensor about the difference they have to expect when compared to traditional assessment techniques of the same parameters and about the reproducibility of the measurements both based on the sensor and based on traditional assessments.

Patients of a single clinic will be offered participation. The patients will perform the eight exercises at a single study visit arranged as an addition to a routine follow up visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients after knee surgery (ACL reconstruction, total or partial knee arthroplasty, knee arthroscopy etc.) who are scheduled to a clinical follow up assessment by the surgeon between 4 months and 15 months after surgery.
  • Informed consent

排除标准

  • Age below 18 years
  • Patients who underwent surgery in the lower extremities within the last 4 months
  • Patients with severe acute pain
  • Patients with contraindications to perform the movements/exercises
  • Patients who underwent surgery also at the contralateral leg since the surgery related to the current follow up visit
  • Patients who cannot follow the instructions due to language or cognitive problems

结局指标

主要结局

Tilt angle of the leg in degrees during passive movement of the leg (knee joint)

时间窗: At the single study visit directly after enrollment of the patient.

Tilt angle of the leg in degrees during active movement of the leg (knee joint)

时间窗: At the single study visit directly after enrollment of the patient.

Tilt angle of the leg in degrees during leg stretching

时间窗: At the single study visit directly after enrollment of the patient.

Inward tilt of the lower leg in degrees/on an ordinal assessment scale during one-legged squat

时间窗: At the single study visit directly after enrollment of the patient.

Angle reproduction when moving the lower leg to three randomly chosen angles

时间窗: At the single study visit directly after enrollment of the patient.

Jump height at vertical jump (on one leg)

时间窗: At the single study visit directly after enrollment of the patient.

Inward tilt of the lower leg in degrees/on an ordinal assessment scale at drop jump

时间窗: At the single study visit directly after enrollment of the patient.

Number of jumps during 30s side hops

时间窗: At the single study visit directly after enrollment of the patient.

次要结局

未报告次要终点

研究者

发起方
crossklinik AG
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Comparing a Sensor for Movement Assessment With... | 临床试验