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OpenTrials
Completed

NCT Number: NCT07011277

Gait Characteristics of Women With Breast Cancer-Related Lymphedema

Upper extremity lymphedema is one of the most common problems associated with cancer treatments in breast cancer survivors. Lymphedema causes asymmetry, changes posture, decreases arm swing due to increased weight, and as a result, may affects the patients' gait. The aim of this study is to examine the gait parameters in women with breast cancer-related lymphedema. Women diagnosed with breast cancer who are referred to the Gazi University Health Sciences Faculty Physiotherapy and Rehabilitation Department Oncological Rehabilitation Unit to receive physiotherapy recommendations and healthy volunteers will be included in the study. The demographic and clinical characteristics of the individuals will be recorded. Body Mass Index (BMI) will be calculated. Then, presence of lymphedema and lymphedema severity will be evaluated by measuring the circumference of the arms with a tape measure. Active shoulder joint movements will be evaluated with goniometer, handgrip strength with K-Force hand dynamometer, spatiotemporal parameters of gait and pelvic symmetry will be evaluated using BTS G-Walk wearable motion analysis system. Women with breast cancer related lymphedema will be compared with healthy women in terms of relevant parameters of gait. In addition, the relationship between lymphedema severity, shoulder joint movement limitation and grip strength with gait parameters in women with breast cancer and lymphedema will be analyzed.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having breast cancer related lymphedema
  • Being between the ages of 25-70
  • Completing cancer treatments

Exclusion criteria

  • Having orthopedic, neurological or vision problems that may affect walking
  • Being in the active treatment process (being in the acute phase after surgery, receiving chemotherapy or radiotherapy)

Treatment and study plan

Primary outcomes

  1. Lymphedema Severity

    Time frame: baseline

    Lymphedema will be assessed by measuring the circumference according to Kuhnke's disc method. The circumference measurement will be assessed by starting from the styloid process of the ulna with a tape measure and extending to the axilla at 4 cm intervals. Lymphedema diagnosis will be confirmed by a difference of more than 2 cm between both extremities and will be classified as mild for differences between both extremities were less than 3 cm, moderate for 3-5 cm and severe for more than 5 cm

  2. Shoulder Range of Motion

    Time frame: baseline

    The patients' active shoulder flexion, abduction, external rotation and internal rotation range of motion will be measured in the supine position with a goniometer and record in degrees.

  3. Handgrip Strength

    Time frame: baseline

    Patients' handgrip strength will be assessed with the K-force Grip dynamometer (Kinvent, Montpellier, France). Patients will be positioned to sit with the shoulder adducted, the elbow flexed at 90°, and the forearm in a neutral position. A total of three measurements will be taken from each patient, and the average of the three measurements will be recorded in kg.

  4. Spatio-temporal Gait Characteristics

    Time frame: baseline

    Gait will be assessed using the BTS G-Walk (BTS Bioengineering, Italy). For gait analysis, a wireless inter-sensor system will be placed at the level of the 5th lumbar vertebra with a semi-elastic belt. This inertial system consists of a triaxial accelerometer, a triaxial magnetometer, a triaxial gyroscope and a GPS receiver. All data are collected at a frequency of 100 Hz and transmitted to a computer via a Bluetooth 3.0 connection. A specific software (BTS G-Studio) allows the processing of the information and the calculation of spatiotemporal gait parameters.

  5. Pelvic Symmetry in Gait

    Time frame: baseline

    Pelvic symmetry will be assed with BTS G-Walk (BTS Bioengineering, Italy). For gait analysis, a wireless inter-sensor system will be placed at the level of the 5th lumbar vertebra with a semi-elastic belt. This inertial system consists of a triaxial accelerometer, a triaxial magnetometer, a triaxial gyroscope and a GPS receiver. All data are collected at a frequency of 100 Hz and transmitted to a computer via a Bluetooth 3.0 connection. A specific software (BTS G-Studio) allows the the processing of the information and the calculation of the percentage of pelvic symmetry between both limbs.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Investigation of Gait Characteristics in Women With Breast Cancer Related Lymphedema

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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