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| Name | Class |
|---|---|
| Fatih Sultan Mehmet Training and Research Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphedema Assessment Group | Experimental | Patients with breast cancer-related lymphedema will undergo MyotonPRO and ultrasound measurements by two blinded raters to evaluate intra- and inter-rater reliability. No therapeutic intervention will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyotonPRO | Device | The MyotonPRO is a non-invasive handheld device that assesses the mechanical and viscoelastic properties of soft tissue (e.g., skin stiffness, elasticity, and relaxation time). In this study, it is used in patients with breast cancer-related lymphedema (BCRL). Each participant is evaluated by two blinded raters to determine intra- and inter-rater reliability. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra- and Inter-Rater Reliability of MyotonPRO Measurements | 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. | Within 1 day |
| Intra- and Inter-Rater Reliability of MyotonPRO Measurements | 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 ICC, which quantifies intra- and inter-rater agreement in repeated biomechanical measurements. | Within 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra Nur Türkmen, MSc, PT | Contact | +90 554 523 9830 | e.nur5313@hotmail.com |
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| Label | URL |
|---|---|
| Related Info | View source |
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Individual participant data (IPD) will not be shared due to confidentiality concerns and institutional data protection policies. The study does not include a plan for secondary data analysis or external data use.
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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Single group assignment. All participants will receive repeated MyotonPRO and ultrasound evaluations for skin biomechanical properties. No randomization or comparison between groups will be performed.
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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.
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |