NCT04742088招募中不适用
Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice
Decathlon SE7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Functional score
研究概览
简要总结
Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Subject is aged ≥18 years old
- •Subject has chronic pain AND / OR chronic ankle instability
- •The current condition of his/her ankle allows the subject to pursue a usual physical activity
- •Subject has been informed and is willing to sign an informed consent form
- •Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
- •Subject is affiliated to the French social security regime
- •Non-inclusion Criteria:
- •Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- •Subject has worn a support (ankle brace or articulated orthosis) during sports sessions during the last month
- •Subject has any medical condition that could impact the study at investigator's discretion
- •Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, elastane, polyester, synthetic rubber)
- •Adult subject to a legal protection measure
排除标准
- 未提供
结局指标
主要结局
Functional score
时间窗: At baseline and 6 weeks of follow-up
Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks
次要结局
- Ankle pain(At 2 weeks and 6 weeks of follow-up)
- Safety (adverse events)(6 weeks of follow-up)
- Confidence level(At baseline and 6 weeks of follow-up)
- Ankle instability(At 2 weeks and 6 weeks of follow-up)
研究者
研究点 (7)
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