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临床试验/NCT06719609
NCT06719609暂停不适用

Enovis High Ankle Sprain Brace Testing

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年10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
暂停
入组人数
30
试验地点
1
主要终点
Comfort of bracing condition - treadmill activity

研究概览

简要总结

The goal of this clinical trial is to learn if a new ankle brace impacts athletic motions. The main questions it aims to answer are:

  • Does it impact motions such as running and cutting?
  • Is it comfortable?

Researchers will compare 5 ankle bracing conditions.

Participants will:

  • Perform a running activity
  • Perform a cutting activity
  • Complete a survey

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Age 18 to 40 at the time of data collection
  • English-speaking
  • Not currently pregnant
  • No history of lower extremity surgery or chronic ankle instability
  • No ankle injuries that required medical attention or ≥ 7 days of modified physical activity within the last 3 months
  • Currently cleared for all physical activity
  • Comfortable running on a treadmill for 10 minutes at a self-selected pace
  • Have prior experience wearing an ankle brace and / or ankle tape during sport activities
  • Shoe size US Men's 7.5-11.5 or Women's 9-13

排除标准

  • 未提供

研究组 & 干预措施

Dynamic agility task

Experimental

Participants will complete a 20-yard shuttle test

干预措施: Low-profile HAS brace (Other)

Dynamic agility task

Experimental

Participants will complete a 20-yard shuttle test

干预措施: No ankle brace or tape (Other)

Running activity

Experimental

Participants will run for 1 minute at varying speeds

干预措施: Ankle tape (Other)

Running activity

Experimental

Participants will run for 1 minute at varying speeds

干预措施: Standard lace-up ankle brace (Other)

Running activity

Experimental

Participants will run for 1 minute at varying speeds

干预措施: Standard high ankle-sprain (HAS) brace (Other)

Running activity

Experimental

Participants will run for 1 minute at varying speeds

干预措施: No ankle brace or tape (Other)

Running activity

Experimental

Participants will run for 1 minute at varying speeds

干预措施: Low-profile HAS brace (Other)

Dynamic agility task

Experimental

Participants will complete a 20-yard shuttle test

干预措施: Ankle tape (Other)

Dynamic agility task

Experimental

Participants will complete a 20-yard shuttle test

干预措施: Standard lace-up ankle brace (Other)

Dynamic agility task

Experimental

Participants will complete a 20-yard shuttle test

干预措施: Standard high ankle-sprain (HAS) brace (Other)

结局指标

主要结局

Comfort of bracing condition - treadmill activity

时间窗: 90 minutes

Participants will rate the comfort of each bracing condition. The comfort scale ranges from completely uncomfortable to completely comfortable.

Movement ability - treadmill activity

时间窗: 90 minutes

Participants will rate how each bracing condition impacted their ability to move. Movement scale ranges from no impact to completely changed my movement.

Ankle stability - treadmill activity

时间窗: 90 minutes

Participants will rate how stable their ankle felt in each bracing condition. Stability scale ranges from very stable to completely unstable.

Likelihood of use during sport - treadmill activity

时间窗: 90 minutes

Participants will rate how likely they are to use each bracing condition during their sport. Likelihood scale ranges from extremely unlikely to extremely likely.

Comfort of bracing condition - shuttle test

时间窗: 90 minutes

Participants will rate the comfort of each bracing condition. The comfort scale ranges from completely uncomfortable to completely comfortable.

Movement ability - shuttle test

时间窗: 90 minutes

Participants will rate how each bracing condition impacted their ability to move. Movement scale ranges from no impact to completely changed my movement.

Ankle stability - shuttle test

时间窗: 90 minutes

Participants will rate how stable their ankle felt in each bracing condition. Stability scale ranges from very stable to completely unstable.

Likelihood of use during sport - shuttle test

时间窗: 90 minutes

Participants will rate how likely they are to use each bracing condition during their sport. Likelihood scale ranges from extremely unlikely to extremely likely.

Ankle joint stability

时间窗: 10 minutes

Ultrasound will be used during Reverse Anterolateral Drawer Test. The examiner will hold the participant's foot stable against the exam table and will use their other hand to translate the participant's tibia/shank posteriorly. A second examiner will record an US video of the ankle joint during this test to measure the relative translation between the talus and the fibula. These procedures will be repeated on the other limb.

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)

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