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Not Yet Recruiting NCT07921290

Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity

Conditions: Lymphedema, Upper Extremity Lymphedema, Breast Cancer Related Lymphedema, Edema

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Enrollment: 64
Sponsor: Karadeniz Technical University

Summary

This study aims to evaluate and compare the measurement reliability, total time cost (preparation, acquisition, post-processing), and participant comfort of conventional limb volume measurement methods (water displacement volumetry, tape-based circumference measurement) against modern digital techniques (LiDAR-based mobile scanning, stereophotogrammetric 3D optical scanning) in the upper extremity. The evaluation will be conducted on both healthy adults and patients diagnosed with upper extremity lymphedema. Additionally, the impact of assessor experience on digital data post-processing and the sensitivity of the methods to detect small localized volume increases using a simulated edema model (50 mL) will be investigated.

Eligibility Criteria

Inclusion Criteria: Healthy Volunteers: * Aged between 18 and 65 years * Voluntarily willing to participate and providing written informed consent * Absence of any known musculoskeletal or neuromuscular deformity, active edema, open wounds, or history of major upper extremity surgery Lymphedema Patients: * Aged between 18 and 65 years * Voluntarily willing to participate and providing written informed consent * Confirmed clinical diagnosis of upper extremity lymphedema * Absence of active skin lesions, open ulcerations, acute cellulitis, or lymphorrhea on the affected upper extremity Exclusion Criteria (Both Groups): * Presence of open wounds, acute skin breakdown, lymphorrhea, active cutaneous infection (cellulitis, fungal infection), or severe dermatological lesions on the tested limb * Severe cognitive, systemic, or physical limitations preventing standard testing positioning (supine posture or holding the limb steady) or safe water immersion * Known severe skin allergy or dermatological hypersensitivity to silicone or adhesive fixation materials (for the healthy cohort undergoing the simulated edema protocol)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07921290). StuddyBuddy aggregates publicly available trial information.