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Ultrasonographic Evaluation and Pedobarographic Correlation of Lower Extremity Muscles in Lipedema Patients (PODUSG)

2026년 7월 21일 업데이트: Marmara University
This study aims to investigate the relationship between lower extremity muscle/tendon characteristics and walking/balance functions in women with lipedema. Lipedema is a condition characterized by abnormal fat accumulation that can lead to walking difficulties and joint problems. We will use ultrasonography to measure muscle thickness and tendon structures, and a pedobarography system to analyze foot pressure distribution during standing and walking. By comparing 45 patients with 45 healthy volunteers, we aim to identify the musculoskeletal causes of gait disorders in lipedema to help develop better prevention and treatment strategies

연구 개요

상태

모병

정황

상세 설명

Lipedema is a disease affecting fat tissues. Fat accumulates abnormally, especially in the hips and lower extremities. It was first described by Worl et al. The cause of the disease is unknown at the current level of scientific knowledge. Lipedema usually occurs in women during adolescence and the third decade. Although there is usually no lymphatic flow dysfunction in these patients, they are often misdiagnosed with lymphedema, but lipedema can cause secondary lymphatic dysfunction, leading to the development of lipolymphedema.

Lipedema is a clinical diagnosis. It is evaluated with appropriate history taking and physical examination. It can be detected by symptoms such as easy bruising, difficulty in losing weight from the legs while losing weight from the trunk, the presence of women with similar conditions in the family, pain on pressure, disproportion between the upper and lower body, pearl-sized nodules on the thighs, and decreased tissue and fascia elasticity on physical examination.

Ultrasonography (USG) muscle thickness measurement is a reliable method for determining regional muscle mass. Previous studies in the literature have evaluated the rectus femoris, gastrocnemius, gluteus medius and posterior tibialis muscles with USG and appropriate measurement techniques have been determined in these studies.

Pedobarography is a technology that evaluates a person's gait, balance, and consequently their locomotor system by examining the pressure distributions on the sole of the foot. It can be used diagnostically in the evaluation of lower extremity pathologies. Pedobarographic examination can provide static, postural, and dynamic evaluation. Static evaluation assesses the plantar pressure distribution during a certain standing time, while postural evaluation examines the pressure distributions in different standing positions. Dynamic evaluation assesses the load distribution on the sole of the foot during walking.

It is known that foot mechanics are affected in patients with lipedema. Considering that the load on the foot is increased in this patient group and that the majority of this load is caused by atypically stored fat, impairment of foot function is inevitable, especially in advanced stages. This is attributed to the valgus position of the knee and the disruption of the medial arch of the foot due to weakness of the knee extensors and hip abductors, and it has also been stated that these alignment problems may be due to gait disorders. Furthermore, it is known that obesity, which may occur simultaneously with lipedema, can lead to additional problems in mobility, and this limited mobility also increases the risk of depression. In addition, predominant sarcopenia in the thigh can be observed in these patients. In this case, weakness of the gluteus medius and quadriceps femoris that may develop contributes to the development of dynamic valgus in the knee. With the development of dynamic valgus, patellar displacement may occur, and as a result, chondromalacia may develop.

Considering the walking problems frequently observed in lipedema patients, it is crucial to address the root causes of these problems, preventing them where possible and detecting them when intervention is required. To achieve this, an assessment of potential problems and identification of related muscle and tendon dysfunctions are necessary to determine their causes. The aim of this study is to evaluate musculoskeletal problems in the lower extremities of lipedema patients, particularly those related to gait and posture, and their functional implications, and to determine the relationship between these functional problems and measurements of muscles and tendons using ultrasonography.

Study Methodology:

Design: Cross-sectional case-control study. Participants: 45 female patients with lipedema and 45 healthy controls. Clinical Evaluation: BMI, waist-hip ratio, leg volume calculation, and Foot Posture Index-6.

Functional Assessment: 6-Minute Walk Test. Questionnaires: Rapprich Lipedema Symptomatic Assessment, LYMPQOL-LEG and Short Form-36 USG Protocol: Measurement of M. Rectus Femoris, Gastrocnemius, Tibialis Posterior, and Gluteus Medius thickness using Esaote MyLab Seven lineer probe [SL1543].

Pedobarography: Static and dynamic 6-phase gait analysis using ACK Medical pedogram system.

Statistical Analysis: Group comparisons and Pearson/Spearman correlation analysis will be performed using SPSS.

연구 유형

관찰

등록 (추정된)

90

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: M. Selim Eryılmaz, Res. Asst.
  • 전화번호: +90 542 48 48 329
  • 이메일: selimerylmz@gmail.com

연구 장소

    • Pendik
      • Istanbul, Pendik, 터키 (Türkiye), 34899
        • 모병
        • Marmara University School of Medicine Pendik Research and Training Hospital
        • 연락하다:
          • Canan Sanal, Assoc. Prof.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

Female patients aged 18-65 years diagnosed with lipedema by a clinician and their age- and BMI-matched healthy volunteers

설명

Inclusion Criteria:

  • Female patients aged 18-65 years and diagnosed with lipedema by a clinician.
  • To agree to participate in the research.

Exclusion Criteria:

  • Positivity of Stemmer's sign (inability to compress the skin between the proximal phalanges of the 2nd and 3rd fingers)
  • Patients with Heart Failure
  • Patients with Chronic Kidney Disease
  • Motor neuron diseases or myositis
  • Diseases causing myositis
  • Patients diagnosed with polyneuropathy
  • Patients with motor-involved L3, L4, L5, or S1 radiculopathy
  • Those unable to ambulate independently
  • Those who cannot tolerate the assessments
  • Pregnant women
  • Congenital or traumatic lower extremity disorders (e.g., developmental hip dysplasia, previous lower extremity fractures with orthopaedic implants).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Lipedema
Patients Diagnosed Lipedema
Healthy Volunteer
Healthy Volunteers thoose age- and BMI-matched

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Lower Extremity Muscle and Tendon Thickness
기간: At baseline (Day 0)
Measurement of thickness (mm) for M. Rectus Femoris, Gastrocnemius Medialis, Tibialis Posterior, and Gluteus Medius muscles, and the Patellar tendon via B-mode Ultrasonography (Esaote MyLab Seven).
At baseline (Day 0)
Tendon Cross-Sectional Area (CSA)
기간: At baseline (Day 0)
Measurement of cross-sectional area (mm^2) for Patellar, Achilles, and Tibialis Posterior tendons using B-mode Ultrasonography (Esaote MyLab Seven).
At baseline (Day 0)

2차 결과 측정

결과 측정
측정값 설명
기간
Static Pedobarographic Weight Distribution
기간: At baseline (Day 0)
Evaluation of the percentage (%) of weight distribution between left and right feet and the forefoot/hindfoot pressure ratio during static standing
At baseline (Day 0)
Center of Pressure (COP) Sway Area
기간: At baseline (Day 0)
Measurement of the area (mm^2) covered by the center of pressure during static standing to assess postural stability.
At baseline (Day 0)
Center of Pressure (COP) Sway Velocity
기간: At baseline (Day 0)
Measurement of the movement speed (mm/s) of the center of pressure during static standing.
At baseline (Day 0)
Dynamic Peak Plantar Pressures
기간: At baseline (Day 0)
Measurement of maximum peak pressures (N/cm^2) across 6 gait phases (Heel Strike, Foot Flat, Mid-stance, Heel Off, Toe Off) using the pedogram system.
At baseline (Day 0)
Clarke's Angle
기간: At baseline (Day 0).
Measurement of Clarke's angle (in degrees) derived from the plantar pressure distribution to objectively evaluate the integrity of the medial longitudinal arch.
At baseline (Day 0).

기타 결과 측정

결과 측정
측정값 설명
기간
Rapprich Lipedema Symptomatic Assessment Score
기간: At baseline (Day 0)
A 15-item scale (0-10 points each) assessing the severity of symptoms such as pain, tension, sensitivity, and easy bruising in the legs. Total score ranges from 0 to 150
At baseline (Day 0)
LYMPQOL-LEG (Lymphedema Quality of Life Questionnaire - Leg)
기간: At baseline (Day 0)
A questionnaire evaluating the impact of the condition on daily activities, symptoms, social life, and clothing choices
At baseline (Day 0)
Foot Posture Index-6 (FPI-6) Score
기간: At baseline (Day 0)
Assessment of foot posture (pronation, supination, or neutral) based on six clinical criteria, providing a total score for foot alignment
At baseline (Day 0)
6-Minute Walk Test (6MWT) Distance
기간: At baseline (Day 0)
Evaluation of functional exercise capacity measured in meters
At baseline (Day 0)
Subcutaneous Fat Tissue Thickness
기간: At baseline (Day 0)
Measurement of subcutaneous fat thickness (mm) at standardized regions (anterior thigh, medial thigh, lateral calf, arm, and forearm) via Ultrasonography (Esaote MyLab Seven).
At baseline (Day 0)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Canan Şanal, Assoc. Prof., Marmara University Faculty of Medicine

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 15일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 9월 15일

연구 등록 날짜

최초 제출

2026년 7월 17일

QC 기준을 충족하는 최초 제출

2026년 7월 21일

처음 게시됨 (실제)

2026년 7월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 21일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • MARPODUSG
  • PODUSG (기타 식별자: Marmara University)

개별 참가자 데이터(IPD) 계획

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미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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