Achilles TendonNCT07197593
Validity and Reliability of Calf Raise Tests in Patients With Achilles Tendon Rupture and Lateral Ankle Sprain
A study testing Calf Raise Test in people with Achilles Tendon and Ankle Sprain, run by Schulthess Klinik.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendon, Ankle Sprain
- What is being tested?
- Calf Raise Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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.
- Conditions
- Achilles Tendon, Ankle Sprain
- Being tested
- Calf Raise Test
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calf Raise TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Calf Raise Test (CRT) App | Other | The validated CRT App allows to accurately measure work, power and peak height in in individuals performing the calf raise test. Receives: Other: Calf Raise Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (6)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: This PROM data will be collected at one time point: at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Validity and reliability study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Maffiuletti, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197593
- Sponsor's protocol ID
- 2025-01043
- Other IDs
- 2025
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Calf Raise Tests in Patients With Achilles Tendon Rupture and Lateral Ankle Sprain
- ClinicalTrials.gov ID
- NCT07197593
- Acronym / sponsor ID
- 2025-01043
- Conditions
- Achilles Tendon, Ankle Sprain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Validity and reliability study
| Arm | Type | Receives |
|---|---|---|
| Calf Raise Test (CRT) App | Other | Other: Calf Raise TestThe validated CRT App allows to accurately measure work, power and peak height in in individuals performing the calf raise test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- LAS individuals: Medial Ligament injuries (Grade II or III) ATR individuals: Previous ATR
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calf Raise TestThe 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. | Other | Calf Raise Test (CRT) App |
Primary outcome
Calf Raise Test (CRT)
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.
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)
6 secondary outcomes
Patient-reported outcome measures (PROM) - FAOS
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - ATRS
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - FFI
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - FAAM
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - UCLA Activity Score
Time frame: This PROM data will be collected at one time point: at baseline.
Patient-reported outcome measure (PROM) - GPAQ
Time frame: This PROM data will be collected at one time point: at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: 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.
Related trials for Achilles Tendon
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Calf Raise Test in people with Achilles Tendon and Ankle Sprain, run by Schulthess Klinik.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calf Raise Test (CRT) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.