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临床试验/NCT04651985
NCT04651985已完成不适用

Effects of Eccentric Strengthening Exercises in Adults With an Achilles Tendinopathy: Predictive Validity and Responsiveness of Quantitative Musculoskeletal Ultrasound Measures

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Responsiveness of a minimal data set of measures obtained with the QUS (quantitative ultrasonography)

研究概览

简要总结

To this day, the most accepted treatment for the Achilles tendinopathy (AT) remains the exercise program to strengthen the plantar flexor muscles. The eccentric exercises protocol proposed by Alfredson is the most popular and recommended one by the rehabilitation professionals. Currently, the response to interventions is measured almost exclusively by clinical data, especially using questionnaires, since the Quantitative Ultrasound (QUS) is rarely used. In fact, the thickness of the Achilles tendon, which is generally the only measure noted when using musculoskeletal ultrasound on AT, does not allow the clinician to confirm an improvement following an eccentric exercise program if the tendon is thinner, especially in adults with chronic AT. No scientific evidence indicates whether there is an improvement in the biological integrity of the Achilles tendon following the completion of Alfredson's eccentric strengthening protocol. This is why it seems relevant to use the pre-established minimal biomarker data set obtained with the QUS in order to study the variation of these data in response to a rehabilitation intervention and to verify how these variations influence clinical data.

详细描述

A comprehensive clinical evaluation (questionnaires, clinical examination and ultrasound imaging) will be completed immediately before the intervention (pre), immediately after the intervention (post), and three months after the intervention (follow-up).

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
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms consistent with AT in the middle third of the Achilles tendon for at least six weeks
  • AT signs objectified by the physical exam and the ultrasound imaging at the initial evaluation
  • At least 18 years old
  • Victorian Institute of Sport Assessment-Achilles Questionnaire (VISA-A) score below 90
  • have pain of at least 3 out of 10 according to the analog visual scale during athletic activities

排除标准

  • Pain at the Achilles tendon enthesis
  • A complete rupture of the Achilles tendon History of Achilles tendon rupture Inflammatory arthropathy
  • Sign of neurological lesion on physical examination of the lower limb
  • Neurological disease (e.g. multiple sclerosis, stroke)
  • History of intervention of the Achilles tendon or ankle (e.g. surgery, cortisone infiltration, extracorporeal shock waves therapy, platelet-rich plasma injection).

结局指标

主要结局

Responsiveness of a minimal data set of measures obtained with the QUS (quantitative ultrasonography)

时间窗: 12 weeks

The primary objective is to determine the responsiveness of a minimal data set of measures obtained with the QUS that characterize the biological integrity of the Achilles tendon (mean thickness, echogenicity, variance, homogeneity at 90 degrees, mean thickness, echogenicity and average homogeneity), after participants have completed the 12-week exercise program.

次要结局

  • Persistence of the QUS measures' modification at 3 months post-intervention(12 weeks)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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