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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07275112
Enrollment
100
Registered
2025-12-10
Start date
2025-12-05
Completion date
2026-01-19
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendinopathy

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.

Interventions

OTHERCross-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.

OTHEREvaluation 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.

Sponsors

Cardenal Herrera University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

.

Design outcomes

Primary

MeasureTime frameDescription
Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)).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.
Internal consistency (Cronbach's alpha coefficient; ranges from 0 to 1.).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.
Construct validityAt 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

MeasureTime frame
Age (years)At baseline.
Sex (Male and female)At baseline.
Weight (kg)At baseline.
BMI (body max index kg/cm2)At baseline.
Height (cm)At baseline.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026