An interventional study of Calf Raise Test in Achilles Tendon and Ankle Sprain, sponsored by Schulthess Klinik. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Schulthess Klinik · Not applicable, Interventional, and Screening
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.
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:
This study is designed to fill these gaps by systematically evaluating the discriminative validity of clinically used CRT parameters between patients with LAS or ATR and healthy controls, as well as the inter-tester reliability of these parameters within patient groups.
350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.
This study's planned enrollment of 70 is above the median of 54 across 270 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →Schulthess Klinik is the lead sponsor of 53 studies on the registry; 11 are open to participants now.
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General Inclusion Criteria:
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.
Exclusion Criteria:
LAS individuals: Medial Ligament injuries (Grade II or III) ATR individuals: Previous ATR
General Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The validated CRT App allows to accurately measure work, power and peak height in in individuals performing the calf raise test.
Other: Calf Raise Test
The study participants perform three single-leg CRTs (tracked by the CRT App) in a fixed sequence: concentric power, eccentric-concentric power and endurance. ATRC/LAS Individuals start with the affected leg, healthy participants with the dominant leg.
Calf Raise Test (CRT)
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)
Time frame: 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.
Patient-reported outcome measures (PROM) - FAOS
For ATR patients, LAS patients and healthy controls \_ specific score I: Foot and Ankle Outcome Score (FAOS). This PROM consists of specific items, which produce a unique numeric score as unit measurement (outcome measure).
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - ATRS
For ATR patients and healthy controls\_ specific score II: Achilles Tendon Total Rupture Score (ATRS). This PROM consists of specific items, which produce a unique numeric score as unit measurement (outcome measure).
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - FFI
For LAS patients and healthy controls \_ specific score III: Functional Foot Index (FFI). This PROM consists of specific items, which produce a unique numeric score as unit measurement (outcome measure).
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - FAAM
For LAS patients and healthy controls \_ specific score IV: Foot and Ankle Ability Measurement (FAAM). This PROM consists of specific items, which produce a unique numeric score as unit measurement (outcome measure).
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - UCLA Activity Score
For ATR patients, LAS patients and healthy controls - generic score (Physical Activity) I: UCLA Activity Score. This PROM consists of specific items, which produce a unique numeric score as unit measurement (outcome measure).
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - GPAQ
For ATR patients, LAS patients and healthy controls - generic score (Physical Activity) II: Global Physical Activity Questionnaire (GPAQ). This PROM consists of specific items, which produce a unique numeric score as unit measurement (outcome measure).
Time frame: This PROM data will be collected at one time point: at baseline.
No study locations are listed for this record.
Plan to share: No — IPD will not be shared. The study involves sensitive clinical data that is subject to privacy protections and institutional regulations. Ownership of the data remains with the clinic, and confidentiality requirements prevent making these data publicly available.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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