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临床试验/NCT06318494
NCT06318494Unknown不适用

Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group

研究概览

简要总结

The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.

The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.

In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.

The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:

25 subjects GROUP A: Study group: patients suffering from ankle instability

25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology

详细描述

Ankle sprains are one of the most common injuries during sports activity which often results in chronic instability of the ankle, characterized by a feeling of sagging more or less associated with pain with impairment of sports activity.

Numerous authors have suggested that there is altered peripheral neuromuscular control in patients with ankle instability with limitations related to proprioception, neuromuscular control, or strength, leading to deficits not only of the ankle joint but of the entire inferior kinetic chain Jumping is a simple gesture, present in almost every sporting activity, and its evaluation has proven to be a reliable parameter in terms of partisan capacity.

Patients suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability will be considered. Patients will be compared to a control group of healthy volunteer subjects.

T0

  • Explanation of the study and written informed consent.
  • Verification of inclusion/exclusion criteria and verification of previous or ongoing treatments.
  • AOFAS Rating Scales,
  • Tegner activity level
  • Vertical Jump Test (CMJ) using OptoGait platform using a battery of monopodalic jumps.
  • Drop jump using an OptoGait platform using a battery of monopodalic jumps
  • Side hop test using an OptoGait platform using a battery of monopod jumps

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Athletes of legal age (aged between 18 and 45 years inclusive) suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability (study group).
  • Athletes of legal age (aged between 18 and 45 years) who are not symptomatic for ankle diseases (control group)
  • Signing of the Informed Consent and consent to collaborate in all study procedures.

排除标准

  • Pregnant women (self-declaration)
  • patients with BMI ≥ 30
  • patients with orthopaedic, muscular and neuromuscular problems at the time of performing the jump
  • Non-acceptance of informed consent
  • Patients with previous unilateral or contralateral ankle reconstructive surgery

研究组 & 干预措施

Patients suffering from ankle instability

Experimental

干预措施: jumping performance (Other)

Healthy volunteer subjects not affected by ankle pathology

Active Comparator

干预措施: jumping performance (Other)

结局指标

主要结局

verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group

时间窗: Day 0

verify the difference in the monopodalic CMJ (countermovement jump test) value of the diseased limb of subjects with ankle instability compared to the control group at time 0

次要结局

未报告次要终点

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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