跳至主要内容
临床试验/NCT05683080
NCT05683080已完成不适用

The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Longitudinal Cohort Study

University of Leicester1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月24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
60
试验地点
1
主要终点
Change in Ultrasound Tissue Characterisation

研究概览

简要总结

The aim of this study is to measure the recovery following Achilles tendon rupture. The investigators will use an ultrasound scan to look at the Achilles tendon, they will complete calf strength tests and use questionnaires to measure how individuals are managing in everyday life. The investigators will take these measurements when participants first arrive to the Achilles tendon rupture clinic, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year.

详细描述

This study will measure the recovery of participants following Achilles tendon rupture. Measurements will be completed following Achilles tendon rupture, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year. The measurements include an ultrasound tissue characterisation scan, isometric (static) strength test and heel raise test. In addition questionnaires will be completed by participants at each time point. Questionnaires include the Achilles Tendon Rupture Score, Hospital Anxiety and Depression Scale, EQ5D (a health related quality of life measure), International Physical Activity Questionnaire, Tampa Scale for Kinesiophobia and the Pain Catastrophising Scale.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to provide informed consent
  • 16 years of age or above

排除标准

  • Inability to provide informed consent due to cognitive impairment
  • Inability to provide informed consent as unable to understand sufficient English

结局指标

主要结局

Change in Ultrasound Tissue Characterisation

时间窗: Week 0, week 8, week 10, 4 months, 6 months and 12 months

Imaging of the Achilles Tendon

次要结局

  • Change in Achilles Tendon Rupture Score(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Change in Hospital Anxiety and Depression Scale(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Change in EuroQol- 5 Dimension -5 Level (EQ5D)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Change in International Physical Activity Questionnaire(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Change in Tampa Scale for Kinesiophobia(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Change in Pain Catastrophising Scale(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Change in Isometric plantarflexor strength testing(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Change in Heel Raise Test(Week 0, week8, week 10, 4 months, 6 months and 12 months)
  • Change in 36-Item Short Form Survey (SF-36)(Week 0, week8, week 10, 4 months, 6 months and 12 months)
  • Change in Activity Level(Week 0, week8, week 10, 4 months, 6 months and 12 months)
  • Change in Sleep Duration(Week 0, week8, week 10, 4 months, 6 months and 12 months)
  • Achilles Tendon Resting Angle(12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验