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临床试验/NCT06602908
NCT06602908已完成不适用

Functional Status for Surgically and Non-surgically Treated Patients With Acute Achilles Tendon Rupture Following a Public Municipal Rehabilitation - A Prospective Cohort Study

Københavns Kommune2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年9月15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
55
试验地点
2
主要终点
Functional test battery: Heel rise test for endurance and maximal height

研究概览

简要总结

A total Achilles tendon rupture is a common injury most often occuring in people aged between 30 and 50 years. The injury is more common amongst men than women (ratio 3:1) and typically occur during sports activities involving excentric and/or plyometric muscle work in plantar flexion of the foot (e.g., jumping, sprinting, change of directions).

Overall, there is no significant difference in treatment outcomes between surgical and non-surgical treatment besides a slightly greater risk of adverse events in surgical treatment and a small increased risk of re-rupture in non-surgical treatment. Several studies have investigated the importance of rehabilitation protocols without outcome differences between groups comparing more or less aggressive strategies.

Achilles tendon rupture often leads to significant limitations in functional level. Some of the most common used outcome measures for functional status are the heel rise tests evaluating endurance and maximum heel rise height. Studies using these tests often shows substantial deficits several years after the injury.

The purpose of this study is to investigate factors associated with functional status after rehabilitation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient has an acute achilles tendon rupture (treated within 14 days after injury).
  • •Adult patients aged of 18 years or older.
  • •Patients has given informed consent to participate in the study.

排除标准

  • •Patients with bilateral achilles tendon rupture
  • •Patients with re-rupture of previous achilles tendon rupture

研究组 & 干预措施

Surgically and non-surgically treated patients with achilles tendon rupture

One hundred patients with surgically and non-surgically treated achilles tendon rupture referred to rehabilitation in the municipality of Copenhagen.

结局指标

主要结局

Functional test battery: Heel rise test for endurance and maximal height

时间窗: LSI is measured at the final visit during rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

Heel rise test for endurance: One legged heel rise test performed in standing position barefooted on the floor with fingertips placed against the wall for balance. Number of repetitions until failure is counted on non-injured leg and afterwards on injured leg. The difference between injured leg and non-injured leg is measured by Limb Symmetry Index in % (LSI): (injured leg)/(non-injured leg) x 100 Heel rise test for maximal height: One legged heel rise test performed in standing position barefooted on the floor with fingertips placed against the wall for balance. The patient is instructed to go as high as possible. The height from the floor until the distal end of calcaneus is measured with a tape measure to the nearest 0.1 cm. The difference between injured leg and healthy leg is measured by Limb Symmetry Index in % (LSI): (injured leg)/(non-injured leg) x 100

次要结局

  • Patient Specific Functional Score (PSFS)(Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.)
  • Pain Numeric Rating Scale (NRS)(Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).)
  • Achilles tendon Total Rupture Score (ATRS)(Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.)
  • Thompsons test(Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).)
  • Achilles Tendon Resting Angle test (ATRA)(Assessment of relative ATRA (difference between non-injured and injured leg) at baseline and the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.)
  • Circumference of lower leg(Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).)
  • The Danish 13-item Tampa Score for Kinesiophobia (TSK-13)(Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).)
  • Tegner score(Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.)

研究者

发起方
Københavns Kommune
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonas Samsø Larsen

Principal investigator. Cand. scient phys. University of Southern Denmark. Developmental physiotherapist, Centre of Rehabilitation Copenhagen City, Denmark

University of Southern Denmark

研究点 (2)

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