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临床试验/NCT03837041
NCT03837041已完成不适用

Evaluate the Proprioception in Patients with Total Knee Arthroplasty

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年3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
入组人数
71
试验地点
1
主要终点
Improvement of a proprioception

研究概览

简要总结

The osteoarthritis (OA) is a chronic and degenerative disease which brings articular cartilage degeneration. As a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty.

Several studies demonstrated the correlation between OA, proprioception reduction and increased risk of falling. The aim of this study is to evaluate the proprioception improvement in patients with total knee arthroplasty.

研究设计

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

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •are patients with ASA: 1, 2 or 3; patients who have given their informed written consent to participate in the study; patients live in Bologna and neighboring areas.

排除标准

  • •are patients with previous osteotomy of the lower limbs; patients with post-traumatic arthrosis; patients with severe preoperative valgus deformity (Hip Knee Ankle angle> 10 °); patients with BMI> 40 kg / m2; patients with rheumatoid arthritis; patients with chronic inflammatory joint diseases; patients with walking diseases (amputations, neuro-muscular diseases, polio, hip dysplasias); patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3); patients with Severe coxarthrosis (Kellgren-Lawrence> 3); patients with severe postural instability; patients with cognitive impairments, patients with concomitant neurological diseases

研究组 & 干预措施

Reconditioning Proprioception group

Active Comparator

Training Proprioception 1 hour for 2 day a week

干预措施: Reconditioning Proprioception (Other)

Control group

No Intervention

结局指标

主要结局

Improvement of a proprioception

时间窗: 24 months

Stability Index (SI) in percentage the maximum is 100%

次要结局

  • Evaluation of performance in lower limb questionnaire(24 months)
  • KSS Score(24 months)
  • Clinical score(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Zaffagnini

Full Professor and Head of department

Istituto Ortopedico Rizzoli

研究点 (1)

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