Marmara University School of Medicine Pendik Research and Training Hospital
Istanbul, Pendik, 34899, Turkey (Türkiye)
Location status: Recruiting
Location contact
Canan Sanal, Assoc. Prof.
CONTACT
NCT Number: NCT07724483
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
Interested in participating?
Request Info18 year–65 year
Female
Observational
Istanbul, Pendik, 34899, Turkey (Türkiye)
Location status: Recruiting
Canan Sanal, Assoc. Prof.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: At baseline (Day 0)
Measurement of the area (mm^2) covered by the center of pressure during static standing to assess postural stability.
Time frame: At baseline (Day 0)
Measurement of the movement speed (mm/s) of the center of pressure during static standing.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At baseline (Day 0)
A questionnaire evaluating the impact of the condition on daily activities, symptoms, social life, and clothing choices
Time frame: At baseline (Day 0)
Assessment of foot posture (pronation, supination, or neutral) based on six clinical criteria, providing a total score for foot alignment
Time frame: At baseline (Day 0)
Evaluation of functional exercise capacity measured in meters
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Canan Şanal, Assoc. Prof.
CONTACT
M. Selim Eryılmaz, Res. Asst.
CONTACT
Marmara University
Other
Acronym: PODUSG
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