NCT07197593

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Oct 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2025May 2026

First Submitted

Initial submission to the registry

September 5, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 5, 2025

Last Update Submit

September 22, 2025

Conditions

Outcome Measures

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)

    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

    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) - FFI

    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.

  • Patient-reported outcome measure (PROM) - UCLA Activity Score

    This PROM data will be collected at one time point: at baseline.

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Calf Raise Test

Interventions

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) App

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Aged 18-65 years
  • German or English speaking
  • 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.

You may not qualify if:

  • 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
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Validity and reliability study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Group, Human Performance Lab

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 29, 2025

Study Start

October 1, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.