Cross-cultural an Reliability and Validity Evaluation of TENDINS-A in Spain
NCT ID: NCT07275112
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-12-05
2026-02-01
Brief Summary
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Once the informed consent has been read and delivered, the evaluator will check that they meet the inclusion criteria. After the data collection, a randomization (Epidat V4.0) of the selected subjects will be carried out to assign them to one of the intervention groups.
Patients must present Achilles pathology and will be recruited through a network of physiotherapy clinics distributed across Spain.
The physiotherapist responsible for their treatment will invite them to participate in the study by providing a QR code granting access to all relevant study documentation. This documentation will include a checkbox in which the patient must indicate that, after reading all the pertinent information, they consent to participate. Without this explicit consent, marked via the checkbox, participation will not be possible.
Once consent is provided, the patient will gain access to three questionnaires to be completed at the same time: VISA-A, FAOS, and TENDINS-A. After 48 hours, they will receive a link to complete the TENDINS-A retest.
When the participant has completed all four questionnaires (VISA-A, FAOS, TENDINS-A, and the TENDINS-A retest), their participation in the study will be considered complete.
The sample size will be calculated following COSMIN recommendations, aiming for a minimum of more than 100 participants to ensure excellent reliability.
Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Cross-cultural adaptation
Cultural and linguistic adaptation process including forward/back translation, expert review, and cognitive debriefing and forward translation, back-translation, expert panel evaluation, cognitive interviews.
Evaluation of reliability and validity
Administration of adapted instrument for reliability and validity assessment and psychometric testing of the adapted questionnaire to evaluate reliability and validity.
Eligibility Criteria
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Inclusion Criteria
* Accept participation in the study (acceptance of informed consent)
* Being a native Spanish speaker
* Be in an age range between 18 and 55 years.
Exclusion Criteria
* Other recent injuries in the affected limb
* Previous surgery in the limb
* Haglund syndrome
* Inflammatory diseases
* Autoimmune diseases
18 Years
99 Years
ALL
No
Sponsors
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Cardenal Herrera University
OTHER
Responsible Party
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SERGIO MONTERO NAVARRO
Principal Investigator
Locations
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Universidad CEU Cardenal Herrera
Elche, Alicante, Spain
Countries
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Central Contacts
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Facility Contacts
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SERGIO MONTERO-NAVARRO, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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CEEI 24/558
Identifier Type: -
Identifier Source: org_study_id