跳至主要内容
临床试验/NCT04225182
NCT04225182已完成不适用

Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation

研究概览

简要总结

The management of knee osteoarthritis via a physical activity protocol for rehabilitation has convincing results. However, the effectiveness of these protocols could be improved with a connected instrumented knee brace with an exercise protocol adapted for the patient which is supervise by an online physiotherapist to check the progression during home-based rehabilitation.

详细描述

The management of knee osteoarthritis via physical activity protocol for rehabilitation has convincing results. The aim of this study is to determine the improvement of the effectiveness of a home-based rehabilitation with and without instrumented knee brace for moderated gonarthrosis patients.

The study will focus during one years on 80 moderated gonarthrosis patients with a Kellgren and Lawrence (K&L) score between 2 and 3, aged between 50 and 80. Each patient will practice an 8 weeks progressive home exercise program with 3 session per weeks. The effectiveness of this protocol will be quantified with a gait analysis with kinematics, kinetics and electromyography, before and after the progressive home exercise protocol. The statistical analysis will focus on ANOVA and correlation between control group and instrumented knee brace group.

研究设计

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

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Person who signed informative consent
  • Affiliated with the social security
  • Male and female aged between 50 and 80
  • Walk without assistance
  • Smartphone's use

排除标准

  • Person under protective measure
  • Orthopedics issues
  • Neurologic issues (MMSE Test < 24)
  • Knee or hip prothesis
  • Person with NSAIDs and analgesics treatment with an effective intake less than 48 hours before the evaluation
  • Predominant patello-femoral arthritis
  • Symptomatic hip OA
  • Knee infection
  • Knee injuries

结局指标

主要结局

Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation

时间窗: At the baseline (inclusion) and after 8 weeks of muscular strengthening

Assessment of knee external knee moment abduction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验