跳至主要内容
临床试验/NCT05676632
NCT05676632已完成不适用

The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Cross Sectional Analysis

University of Leicester1 个研究点 分布在 1 个国家目标入组 90 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
90
试验地点
1
主要终点
Ultrasound Tissue Characterisation

研究概览

简要总结

This project will assess the clinical outcomes of individuals completing rehabilitation for their Achilles tendon rupture at the University Hospitals of Leicester. Patients attending the Achilles tendon rupture clinic or rehabilitation classes will be asked to complete ultrasound imaging, strength testing and questionnaires. This will provide an insight into the rehabilitation outcomes of a broad range of patients at each rehabilitation timepoint.

详细描述

This study will measure the recovery of participants following Achilles tendon rupture. Measurements will capture individual participants at each rehabilitation time point following Achilles tendon rupture. These time points include following rupture (week 0), 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
Other
时间视角
Cross Sectional

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

Ultrasound Tissue Characterisation

时间窗: 12 months

Imaging of the Achilles Tendon

次要结局

  • Isometric plantarflexor strength testing(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Achilles Tendon Rupture Score (ATRS)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • 36-Item Short Form Survey (SF-36)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Heel Raise Test(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • EuroQol- 5 Dimension - 5 Level (EQ-5D-5L)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Tampa Scale of Kinesiophobia (TSK)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Pain Catastrophizing Scale (PCS)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Hospital Anxiety and Depression Scale (HADS)(Week 0, week 8, week 10, 4 months, 6 months and 12 months)
  • Accelerometer(Week 0, week 8, week 10, 4 months, 6 months and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Impact of Achilles Tendon Ruptures: Cross-Sectional... | 临床试验