Clinical trial · Interventional
Reliability of Myoton in Evaluating Skin Biomechanics in Breast Cancer-Related Lymphedema
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer-Related Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MyotonPRO | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymphedema Assessment Group
- description
- 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.
- interventionNames
- Device: MyotonPRO
Primary outcomes (2)
- measure
- Intra- and Inter-Rater Reliability of MyotonPRO Measurements
- timeFrame
- Within 1 day
- description
- 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.
- measure
- Intra- and Inter-Rater Reliability of MyotonPRO Measurements
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available