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

NCT07086053 | Not Yet Recruiting

• 1 other identifier: FSM-MYOTON-2025-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer-Related Lymphedema

Keywords

Lymphedema; Breast Cancer; Myoton; Skin Stiffness; Ultrasound; Reliability

Outcome Measures

Primary Outcomes (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 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

Study Arms (1)

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.

Device: MyotonPRO

Interventions

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.

Lymphedema Assessment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead
• Fatih Sultan Mehmet Training and Research Hospital: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Esra Nur Türkmen, MSc, PT

CONTACT

+90 554 523 9830; e.nur5313@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer / Specialist Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share