Gait Characteristics of Women With Breast Cancer-Related Lymphedema

• Conditions: Breast Cancer Related Lymphedema

• Registration Number: NCT07011277
• Lead Sponsor: Gazi University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-20
• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2025-06-20
• Study Completion: 2025-07-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shoulder Range of Motion	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.
Lymphedema Severity	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
Spatio-temporal Gait Characteristics	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.
Handgrip Strength	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.
Pelvic Symmetry in Gait	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.

Trial Locations

Locations (1)

Gazi University Faculty of Health Sciences; 🇹🇷 Ankara, Turkey