Reliability of Myoton in Evaluating Skin Biomechanics in Breast Cancer-Related Lymphedema

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorKahramanmaras Sutcu Imam University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Lymphedema Assessment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 1 day
2

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.

Time frame
Within 1 day

Secondary outcomes

Other outcomes

Locations

This trial has no 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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