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临床试验/NCT07197593
NCT07197593尚未招募不适用

Validity and Reliability of Calf Raise Tests in Patients With Achilles Tendon Rupture and Lateral Ankle Sprain

Schulthess Klinik0 个研究点目标入组 70 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Calf Raise Test (CRT)

研究概览

简要总结

This study aims to evaluate the validity and reliability of clinically used Calf Raise Test parameters (collected with the "the Calf Raise App") between patients with Lateral Ankle Sprain or Achilles Tendon Repair and healthy controls.

详细描述

Lateral ankle sprains (LAS) are the most common lower limb injury in sports, affecting the lateral ligament complex in 80% of cases. Diagnosis is based on clinical evaluation (mechanism of injury, history, weight-bearing status, ligament integrity tests) and conservative treatment is recommended in the absence of additional injuries. However, up to 40% of LAS patients develop chronic ankle instability (CAI), that is characterized by persistent pain, instability, and recurrent sprain. Despite the absence of direct injury to the calf muscle-tendon unit, LAS patients may experience plantar flexor strength deficits for up to 6 months, making calf function assessment crucial for rehabilitation and return to sport purposes. The International Ankle Consortium Rehabilitation-Oriented Assessment (ROAST) recommends isokinetic and hand-held dynamometry for muscle strength testing; however, these methods are often impractical in clinical settings. As a result, the single-leg heel raise test (calf raise test) is already widely used in clinical practice as a pragmatic alternative to assess plantar flexor function and to monitor rehabilitation progress over time.

Achilles tendon rupture (ATR) is another common injury that severely impacts calf muscle-tendon function. The Achilles tendon, formed by the gastrocnemius and soleus muscles, is the strongest tendon in the human body and can withstand forces up to 17 times body weight. Ruptures occur when the tendon is overstretched, with elongation beyond 8% resulting in visible structural failure. Recent epidemiological data point to an incidence of ATR of 41.7 cases per 100,000 person-years in Sweden and 29.3 per 100,000 person-years in Ontario, Canada, with men aged 30-50 being the most affected.

In both LAS and ATR patients, the evaluation of calf muscle-tendon function is essential for individualized rehabilitation and for monitoring functional recovery over time. The calf raise test (CRT) is a widely used tool for evaluating calf muscle-tendon function, with good validity and reliability (intraclass correlation coefficients [ICC] of 0.57 to 0.99 and Pearson's correlation coefficients [r] of 0.56 to 0.98). Traditionally, the CRT measures muscular endurance by counting repetitions until task failure. However, recent research suggests that peak displacement and power output may be more sensitive indicators of functional deficits in Achilles tendon rehabilitation. Additionally, measuring power alongside endurance may better reflect the demands of sport-related activities.

Although such parameters have long been measurable in laboratory settings, these technologies are expensive, require specialized personnel, and are often inaccessible in routine clinical environments. Recent advances in digital health technology-most notably the development of validated mobile applications such as the Calf Raise App-now enable reliable, objective, and cost-efficient quantification of displacement, power and work during the CRT. As such, calf raise power obtained during a modified app-controlled CRT has shown a significant correlation with 10-m sprint times in rugby players (R² values ranging from 0.25 to 0.39, p < 0.05).

Despite the frequent use of various CRTs in rehabilitation settings for LAS and ATR patients, several important aspects remain unexplored. Specifically:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • General Inclusion Criteria:
  • Signed informed consent
  • Aged 18-65 years
  • German or English speaking
  • Inclusion Criteria:
  • LAS individuals: Unilateral LAS 4-16 weeks post-injury diagnosed by a physician as LAS, supination trauma, ankle distortion or ligamentous ankle injury.
  • ATR individuals: Unilateral ATR 6- 24 months post-injury/surgery (surgical or conservative treatment).
  • Healthy controls: Matched to Patients by Group Level: Physical Activity, Age and Gender.

排除标准

  • LAS individuals: Medial Ligament injuries (Grade II or III) ATR individuals: Previous ATR
  • General Exclusion Criteria:
  • Chronic Ankle Instability (defined by symptoms such as giving way, perceived instability and at least one LAS within the last 6 months)
  • Previous ATR
  • Other lower limb injury and/or surgery in the last year (e.g. fractures, ligament reconstructions or other conditions resulting in ≥ 6 months of sports inactivity)
  • Impaired motor function of the lower limb due to neurovascular or neurological diseases
  • Vestibular or visual disturbances
  • Or any other pathoanatomic abnormality that would affect motor performance (e.g. foot arthrodesis, toe amputation/missing toes or other conditions such as joint deformities, severe chronic pain).

结局指标

主要结局

Calf Raise Test (CRT)

时间窗: The CRT data will be collected at two time points: at baseline and after a 30- min break. Total time of data collection: ca. 1 hour.

The CRT (evaluated by the use of the CRT App) yields three different variables of interest: * Concentric power CRT: peak power (W) during the ascending phase * Eccentric-concentric power CRT: peak power (W) during the ascending phase * Endurance CRT: number of repetitions (n), total positive work (W), and total positive displacement (cm)

次要结局

  • Patient-reported outcome measures (PROM) - FAOS(This PROM data will be collected at one time point: at baseline.)
  • Patient-reported outcome measure (PROM) - ATRS(This PROM data will be collected at one time point: at baseline.)
  • Patient-reported outcome measure (PROM) - GPAQ(This PROM data will be collected at one time point: at baseline.)
  • Patient-reported outcome measure (PROM) - FFI(This PROM data will be collected at one time point: at baseline.)
  • Patient-reported outcome measure (PROM) - UCLA Activity Score(This PROM data will be collected at one time point: at baseline.)
  • Patient-reported outcome measure (PROM) - FAAM(This PROM data will be collected at one time point: at baseline.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Maffiuletti

Head of Research Group, Human Performance Lab

Schulthess Klinik

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