About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Bilateral upper extremity lymphedema
Cognitive or mental disorders that interfere with cooperation
Neurological diseases
Active infection
Trial design
Single group
Treatments tested in this trial
MyotonPRO
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kahramanmaras Sutcu Imam University
Lead sponsor
Fatih Sultan Mehmet Training and Research Hospital
Collaborator
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