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临床试验/NCT05868681
NCT05868681已完成不适用

Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年2月12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
11
试验地点
2
主要终点
Static and Dynamic Stability Index

研究概览

简要总结

The objective of the study is to evaluate post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to ankle instability.

详细描述

The patients will then be divided into two control groups: one group will undergo reconditioning through the Delos system and one group will undergo standard rehabilitation treatment.

Primary outcome: improvement of joint stability and postoperative proprioception after reconditioning with the Delos system.

Secondary outcomes: improvement of performance indicators and reduction of disability and satisfaction and assessment of long-term ankle stability after reconditioning with Delos system.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients already undergoing surgery and with at least 4 months of follow-up;
  • patients of both sexes aged between 18-40 years;
  • patients who have given their informed written consent to participate in the study;
  • patients who have given the willingness to reach the Hospital to carry out the checks.

排除标准

  • patients with BMI> 30 kg / m2;
  • patients with rheumatoid arthritis;
  • patients with chronic inflammatory joint diseases;
  • patients with pre-existing deambulation kinematics abnormalities (amputations, neuro- muscular diseases, polio, hip dysplasias);
  • patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3);
  • patients with Severe knee arthritis (Kellgren-Lawrence> 3);
  • patients with severe postural instability;
  • patients with cognitive impairments;
  • patients with concomitant neurological diseases.

结局指标

主要结局

Static and Dynamic Stability Index

时间窗: 5 weeks from the start of rehabilitation treatment

Evaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index.

次要结局

  • Clinical test(5 weeks from the start of rehabilitation treatment)
  • Personal perception of the patient(5 weeks from the start of rehabilitation treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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