Cross-cultural an Reliability and Validity Evaluation of TENDINS-A in Spain

NCT ID: NCT07275112

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2026-01-19

Brief Summary

Volunteers who want to participate in the study will read the general information of the study and sign the informed consent to participate in the study.

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.

Conditions

Achilles Tendinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Present Achilles tendinopathy
• 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

• Complete or partial tendon rupture
• Other recent injuries in the affected limb
• Previous surgery in the limb
• Haglund syndrome
• Inflammatory diseases
• Autoimmune diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

SERGIO MONTERO NAVARRO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad CEU Cardenal Herrera

Elche, Alicante, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

CEEI 24/558

Identifier Type: -

Identifier Source: org_study_id