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Completed

NCT Number: NCT07275112

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

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.

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Key information

Conditions

Achilles Tendinopathy

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad CEU Cardenal Herrera

Elche, Alicante, 03204, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Do not present any exclusion criteria.

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

Treatment and study plan

Cross-cultural adaptation

Other

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

Other

Administration of adapted instrument for reliability and validity assessment and psychometric testing of the adapted questionnaire to evaluate reliability and validity.

Primary outcomes

  1. Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)).

    Time frame: Baseline and 2-3 days after the first administration.

    Degree of stability of the adapted questionnaire scores when administered twice to the same participants under similar conditions. ICC values with 95% confidence intervals.

  2. Internal consistency (Cronbach's alpha coefficient; ranges from 0 to 1.).

    Time frame: At baseline.

    Internal homogeneity of the items of the adapted questionnaire. Calculation of Cronbach's alpha for total score and subscales (if applicable). 0.90 or higher: Excellent reliability.

    0.80 to 0.89: Good internal consistency. 0.70 to 0.79: Acceptable reliability (the minimum standard in research). Less than 0.50: Unacceptable consistency.

  3. Construct validity

    Time frame: At baseline.

    Degree to which the adapted instrument reflects the theoretical construct it is intended to measure. Exploratory Factor Analysis (EFA) and/or Confirmatory Factor Analysis (CFA), depending on design.

Secondary outcomes

  1. Age (years)

    Time frame: At baseline.

  2. Sex (Male and female)

    Time frame: At baseline.

  3. Weight (kg)

    Time frame: At baseline.

  4. BMI (body max index kg/cm2)

    Time frame: At baseline.

  5. Height (cm)

    Time frame: At baseline.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Cross-cultural Adaptation of the TENDINopathy Severity Assessment-Achilles (TENDINS-A) for the Spanish Population and Evaluation of Its Reliability and Validity in Accordance With COSMIN Recommendations

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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