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Not yet recruitingNCT07197593Updated Sep 29, 2025

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

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

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  • The discriminative (known group) validity of CRT-derived endurance to distinguish LAS patients from healthy individuals has not yet been established.
  • In the same way, the discriminative validity of CRT-derived power to differentiate LAS or ATR patients from healthy controls is not known.
  • The inter-tester reliability of CRT-derived endurance has not been assessed specifically in LAS patients.
  • Similarly, the inter-tester reliability of CRT-derived power has never been evaluated in either LAS or ATR patients.

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.

02

Conditions studied

  • Achilles Tendon
  • Ankle Sprain

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03

In context

Ankle Injuries

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 →

Lead sponsor

Schulthess Klinik is the lead sponsor of 53 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

General Inclusion Criteria:

  • Signed
  • Aged 18-65 years
  • German or English speaking

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

Exclusion Criteria:

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).
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Other
    Calf Raise Test (CRT) App

    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

Interventions

  • OtherCalf 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.

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07197593
Lead sponsor
Schulthess Klinik
Responsible party
Nicola Maffiuletti (Head of Research Group, Human Performance Lab, Schulthess Klinik) — Principal investigator
First posted
Sep 29, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Sep 29, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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