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
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cardenal Herrera University
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)).
概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Test-retest reliability (Intraclass Correlation Coefficient (ICC 2,1)).
时间窗: 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.).
时间窗: 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 validity
时间窗: 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.
次要结局
- Weight (kg)(At baseline.)
- BMI (body max index kg/cm2)(At baseline.)
- Age (years)(At baseline.)
- Sex (Male and female)(At baseline.)
- Height (cm)(At baseline.)
研究者
SERGIO MONTERO NAVARRO
Principal Investigator
Cardenal Herrera University