Inter-rater And Intra-rater Reliability Of Biomechanical Skin Stiffness Characteristics Measurement Via MyotonPRO Device In Patients With Breast Cancer-Related Lymphedema (BCRL) And Their Relationship With Ultrasonographic Tissue Changes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Intra- and Inter-Rater Reliability of MyotonPRO Measurements
研究概览
简要总结
This study aims to evaluate the intra- and inter-rater reliability of the MyotonPRO, a handheld device that measures the viscoelastic properties of the skin, in patients with breast cancer-related lymphedema. Twenty women with unilateral upper extremity lymphedema will be included. Each participant will undergo repeated skin assessments using the MyotonPRO by two independent raters. Additionally, ultrasonographic tissue characteristics and limb volume measurements will be performed. The findings are expected to contribute to the validation of the MyotonPRO for use in clinical lymphedema evaluation.
详细描述
The study will be conducted at a single center with 20 women diagnosed with unilateral upper extremity lymphedema after mastectomy. Participants will be evaluated using the MyotonPRO device by two trained raters to assess intra- and inter-rater reliability. Ultrasonographic grading of subcutaneous echogenicity and echo-free space, as well as circumference and volume measurements, will be conducted to explore correlations with biomechanical tissue properties. Statistical analysis will include intraclass correlation coefficient (ICC) for reliability and Pearson correlation for validity. This study is expected to support the clinical use of MyotonPRO in lymphedema assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Although the study is single-arm, outcome assessments were performed by two blinded assessors to evaluate measurement reliability. No group assignment or treatment comparison is involved.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-80 years
- •Unilateral upper extremity lymphedema secondary to breast cancer surgery
- •Diagnosed with lymphedema at International Society of Lymphology (ISL) Stage 0, I, II, or III
- •Willing and able to provide informed consent
排除标准
- •Bilateral upper extremity lymphedema
- •Cognitive or mental disorders that interfere with cooperation
- •Neurological diseases
- •Active infection
- •Scleroderma or other skin disorders affecting elasticity
- •Significant cardiac conditions that may interfere with assessment
结局指标
主要结局
Intra- and Inter-Rater Reliability of MyotonPRO Measurements
时间窗: Within 1 day
The reliability of the MyotonPRO device will be evaluated through repeated measurements of skin stiffness parameters by two independent raters on the same day. The primary outcome is the intraclass correlation coefficient (ICC) for intra- and inter-rater agreement.
次要结局
未报告次要终点
研究者
Esra Nur Turkmen
Lecturer / Specialist Physiotherapist
Kahramanmaras Sutcu Imam University