Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-09 @ 6:57 AM
Study NCT ID:
NCT07275112
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross-cultural an Reliability and Validity Evaluation of TENDINS-A in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-28', 'size': 423482, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-11-28T06:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2025-11-28', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)).', 'timeFrame': 'Baseline and 2-3 days after the first administration.', 'description': 'Degree of stability of the adapted questionnaire scores when administered twice to the same participants under similar conditions. ICC values with 95% confidence intervals.'}, {'measure': "Internal consistency (Cronbach's alpha coefficient; ranges from 0 to 1.).", 'timeFrame': 'At baseline.', 'description': "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.\n\n0.80 to 0.89: Good internal consistency. 0.70 to 0.79: Acceptable reliability (the minimum standard in research). Less than 0.50: Unacceptable consistency."}, {'measure': 'Construct validity', 'timeFrame': 'At baseline.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Age (years)', 'timeFrame': 'At baseline.'}, {'measure': 'Sex (Male and female)', 'timeFrame': 'At baseline.'}, {'measure': 'Weight (kg)', 'timeFrame': 'At baseline.'}, {'measure': 'BMI (body max index kg/cm2)', 'timeFrame': 'At baseline.'}, {'measure': 'Height (cm)', 'timeFrame': 'At baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achilles Tendinopathy']}, 'descriptionModule': {'briefSummary': '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.\n\nOnce 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.\n\nPatients must present Achilles pathology and will be recruited through a network of physiotherapy clinics distributed across Spain.\n\nThe 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.\n\nOnce 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.\n\nWhen 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.\n\nThe sample size will be calculated following COSMIN recommendations, aiming for a minimum of more than 100 participants to ensure excellent reliability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Achilles tendinopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Present Achilles tendinopathy\n* Accept participation in the study (acceptance of informed consent)\n* Being a native Spanish speaker\n* Be in an age range between 18 and 55 years.\n* Do not present any exclusion criteria.\n\nExclusion Criteria:\n\n* Complete or partial tendon rupture\n* Other recent injuries in the affected limb\n* Previous surgery in the limb\n* Haglund syndrome\n* Inflammatory diseases\n* Autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT07275112', 'briefTitle': 'Cross-cultural an Reliability and Validity Evaluation of TENDINS-A in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CEEI 24/558'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cross-cultural adaptation', 'type': 'OTHER', 'description': 'Cultural and linguistic adaptation process including forward/back translation, expert review, and cognitive debriefing and forward translation, back-translation, expert panel evaluation, cognitive interviews.'}, {'name': 'Evaluation of reliability and validity', 'type': 'OTHER', 'description': 'Administration of adapted instrument for reliability and validity assessment and psychometric testing of the adapted questionnaire to evaluate reliability and validity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03204', 'city': 'Elche', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'SERGIO MONTERO-NAVARRO, PhD', 'role': 'CONTACT', 'email': 'sergio.montero@uchceu.es'}], 'facility': 'Universidad CEU Cardenal Herrera', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'centralContacts': [{'name': 'José Miguel Soria López, Phd', 'role': 'CONTACT', 'email': 'jose.soria@uchceu.es', 'phone': '965426486', 'phoneExt': '67710'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SERGIO MONTERO NAVARRO', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}