Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Comparison of Reliability, Time Cost, and Participant Comfort of Volumetric, Circumference Measurement, LiDAR, and 3D Modeling Methods in Upper Extremity Volume Measurement
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.
Přehled studie
Postavení
Detailní popis
Upper extremity lymphedema is a chronic and progressive condition characterized by the accumulation of protein-rich interstitial fluid, leading to tissue fibrosis and structural volume increases. Precise, reliable, and practical limb volume measurement is vital for diagnosis, staging, and therapeutic monitoring. While water displacement volumetry remains the gold standard, it poses practical challenges including cross-contamination risks, prolonged setup, and inapplicability to patients with wounds or severe limitations. Circumference tape measurement with frustum modeling is widely used but suffers from high examiner dependency and geometric approximation errors. Emerging non-contact technologies, such as mobile Light Detection and Ranging (LiDAR) sensors and optical 3D surface scanning, offer rapid, hygienic, and objective alternatives. However, gaps remain regarding their sensitivity to subclinical volume variations, the influence of post-processing operator experience, procedural time costs, and participant burden.
This methodological, comparative, cross-sectional pilot study evaluates upper extremity volume assessment methods across two cohorts: healthy adults (n = 40) and individuals clinically diagnosed with upper extremity lymphedema (n = 24). Measurements are conducted on the dominant upper extremity in healthy participants and on the affected upper extremity in patients with lymphedema, demarcated from the ulnar styloid process to 2-3 cm distal to the axilla.
All participants undergo the following sequentially:
- Water Displacement Volumetry: Conducted using a custom overflow tank and precision graduated cylinders as the reference standard. The hand volume is measured first and subtracted from the full-arm immersion volume. Strict decontamination protocols are applied between sessions.
- Circumference Measurement: Circumferential measures are taken at 4 cm intervals in a supine position and converted to limb volume using the truncated cone (Kuhnke/Frustum) formula. Measurements are obtained independently by both an experienced and an inexperienced evaluator.
- LiDAR-Based Scanning: Acquired using an iPad equipped with Structure Sensor 3 (Structure application). Standardized positioning is utilized with adhesive anatomical landmarks.
- Photogrammetric/Optical 3D Scanning: Acquired using the Creality Raptor X 3D scanner (Creality Scan software).
To address operator dependency in digital workflows, raw 3D point-cloud processing, mesh trimming, and volumetric integration are performed under a blinded protocol by both an experienced operator and an inexperienced operator.
In the healthy adult cohort, a simulated localized edema protocol is additionally conducted to determine method sensitivity to small volume fluctuations. A non-absorbent medical silicone pad (calibrated to exactly 50 mL via prior water volumetry) is affixed to the participant's forearm, after which circumference, LiDAR, and 3D optical scanning procedures are repeated.
Comprehensive time-motion analyses are recorded with a digital stopwatch across three distinct phases for each modality: equipment preparation, data acquisition, and post-processing computation. Participant-reported outcomes, including physical discomfort and fatigue, are documented using a Visual Analog Scale (VAS, 0-100 mm) immediately after each test and ranked comparatively at session conclusion.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Burak Erturk, PT, PhD
- Telefonní číslo: +90 462 377 4250
- E-mail: burak.erturk@ktu.edu.tr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Healthy adult volunteers and clinical patients diagnosed with upper extremity lymphedema evaluated at the physical therapy and rehabilitation laboratories.
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
|---|
|
Healthy Adults
Forty healthy adult volunteers aged 18 to 65 years with no known deformity, edema, open wound, or prior surgical history in the upper extremity. Participants undergo baseline upper extremity volume assessments on their dominant arm using water displacement volumetry, tape-based circumference measurement (performed independently by experienced and inexperienced evaluators), LiDAR-based scanning (Structure Sensor 3), and stereophotogrammetric 3D optical scanning (Creality Raptor X). Additionally, to determine method sensitivity to small volume fluctuations, participants undergo a simulated edema protocol wherein a calibrated 50 mL non-absorbent medical silicone pad is affixed to the forearm, followed by repeat circumference, LiDAR, and 3D optical scans. |
|
Patients with Lymphedema
Twenty-four adult individuals aged 18 to 65 years clinically diagnosed with upper extremity lymphedema, without active skin lesions, open wounds, or lymphorrhea on the affected limb. Participants undergo upper extremity volume measurements on their affected arm using water displacement volumetry, tape-based circumference measurement (performed independently by experienced and inexperienced evaluators), LiDAR-based scanning (Structure Sensor 3), and stereophotogrammetric 3D optical scanning (Creality Raptor X). The simulated edema protocol is not applied to this cohort. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Upper Extremity Limb Volume
Časové okno: Assessed during the single cross-sectional experimental testing session (approximately 1 to 2 hours per participant).
|
Total upper extremity limb volume (measured in milliliters, mL) evaluated across four measurement modalities: water displacement volumetry (gold standard reference), circumference tape measurement (calculated using the truncated cone / Frustum formula), LiDAR-based scanning (Structure Sensor 3), and stereophotogrammetric 3D optical scanning (Creality Raptor X). Measurement agreement and reliability will be determined using the Intraclass Correlation Coefficient (ICC Model 3,1) and Bland-Altman limits of agreement. Digital 3D model post-processing and tape measurements will be evaluated comparatively between experienced and inexperienced assessors. |
Assessed during the single cross-sectional experimental testing session (approximately 1 to 2 hours per participant).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Procedural Time Cost (Process Duration)
Časové okno: Throughout the 4-hour experimental protocol window (from 1 hour prior to participant arrival, during the 2-hour assessment session, through 1 hour following participant departure)
|
Total time cost (measured in minutes and seconds using a digital stopwatch) required for each modality, tracked across three distinct phases: preparation time (equipment setup, sanitation, and participant positioning), data acquisition time (actual measurement/scanning), and analysis/post-processing time (mathematical formula calculation or digital point-cloud cropping and mesh volume computation). |
Throughout the 4-hour experimental protocol window (from 1 hour prior to participant arrival, during the 2-hour assessment session, through 1 hour following participant departure)
|
|
Participant-Perceived Discomfort and Fatigue
Časové okno: Immediately after each measurement procedure and at the end of the visit (within 2 hours)
|
Participant-reported physical discomfort and fatigue assessed immediately following each measurement modality using a Visual Analog Scale (VAS, 0 to 10 cm, where 0 represents 'no discomfort/fatigue' and 10 represents 'extreme discomfort/fatigue'). Overall method preference and willingness to repeat the procedure will be ranked at the conclusion of all tests. |
Immediately after each measurement procedure and at the end of the visit (within 2 hours)
|
|
Sensitivity to Localized Small Volume Changes (Simulated Edema Absolute Error)
Časové okno: Immediately following baseline measurements during the single study visit (at approximately 1 hour post-baseline)
|
Absolute measurement error (calculated in milliliters, mL) in detecting an artificial, localized 50 mL volume increase. In the healthy adult cohort, a calibrated, non-absorbent medical silicone pad (50 mL verified via water displacement) is affixed to the forearm. The error is determined as the absolute difference between the volume change detected by circumference tape, LiDAR, and 3D optical scanning and the true 50 mL volume of the pad. |
Immediately following baseline measurements during the single study visit (at approximately 1 hour post-baseline)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Burak Erturk, PT, PhD, Karadeniz Technical University
Publikace a užitečné odkazy
Obecné publikace
- Rodriguez-Mendez BG, Lopez-Callejas R, Mercado-Cabrera A, Pena-Eguiluz R, Valencia-Alvarado R, Betancourt-Angeles M, Berrones-Stringel G, Jaramillo-Martinez C. Harnessing Non-Thermal Plasma to Supercharge Recovery in Abdominal Surgeries: A Pilot Study. J Clin Med. 2024 Jan 11;13(2):408. doi: 10.3390/jcm13020408.
- Huang X, Zheng W, Pearce R, Zhang Y. SSIPe: accurately estimating protein-protein binding affinity change upon mutations using evolutionary profiles in combination with an optimized physical energy function. Bioinformatics. 2020 Apr 15;36(8):2429-2437. doi: 10.1093/bioinformatics/btz926.
- Glynn D, Campbell B, Marlow M, Patrick H. How to improve the quality of evidence when new treatments are funded conditional on collecting evidence of effectiveness and safety. J Health Serv Res Policy. 2016 Apr;21(2):71-2. doi: 10.1177/1355819615621584. Epub 2015 Dec 17. No abstract available.
- Murray A, Allen V. Angioplasty pressure-volume measurement. Med Biol Eng Comput. 1995 Sep;33(5):747-8. doi: 10.1007/BF02510800.
- Lubinski J, Gorski B, Huzarski T, Byrski T, Gronwald J, Serrano-Fernandez P, Domagala W, Chosia M, Ucinski M, Grzybowska E, Lange D, Maka B, Mackiewicz A, Karczewska A, Breborowicz J, Lamperska K, Stawicka M, Gozdecka-Grodecka S, Bebenek M, Sorokin D, Wojnar A, Haus O, Sir J, Mierzwa T, Niepsuj S, Gugala K, Gozdz S, Sygut J, Kozak-Klonowska B, Musiatowicz B, Posmyk M, Kordek R, Morawiec M, Zambrano O, Wasko B, Fudali L, Skret J, Surdyka D, Urbanski K, Mitus J, Rys J, Szwiec M, Rozmiarek A, Dziuba I, Wandzel P, Wisniowski R, Szczylik C, Kozak A, Kozlowski W, Narod SA. BRCA1-positive breast cancers in young women from Poland. Breast Cancer Res Treat. 2006 Sep;99(1):71-6. doi: 10.1007/s10549-006-9182-3. Epub 2006 Mar 16.
- Li J, Liu S, Fu J, Yin J, Zhao J, Zhong C, Cao G. Co-Occurrence of Colistin and Meropenem Resistance Determinants in a Stenotrophomonas Strain Isolated from Sewage Water. Microb Drug Resist. 2019 Apr;25(3):317-325. doi: 10.1089/mdr.2018.0418. Epub 2019 Mar 13.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-232
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Individual participant data will not be shared publicly because this investigation constitutes the foundational baseline phase of a multi-stage longitudinal research project. The acquired normative volumetric, photographic, and point-cloud datasets will be actively utilized as prospective control and benchmark data in subsequent interrelated clinical and technological validation phases.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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