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

NCT07275112 | Completed

• 1 other identifier: CEEI 24/558
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

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

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

  Baseline and 2-3 days after the first administration.

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

  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.

  At baseline.

• Construct validity

  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.

  At baseline.

Secondary Outcomes (5)

• 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.

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Achilles tendinopathy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Elche, Alicante, 03204, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: December 5, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 19, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

ES (1)