Gait Characteristics of Women With Breast Cancer-Related Lymphedema

NCT07011277 | Completed

• 1 other identifier: Breast Cancer-Gait Analysis
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Related Lymphedema

Keywords

breast cancer; lymphedema; gait disorders; upper extremity disorders

Outcome Measures

Primary Outcomes (5)

• Lymphedema Severity

  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

  baseline

• Shoulder Range of Motion

  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.

  baseline

• Handgrip Strength

  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.

  baseline

• Spatio-temporal Gait Characteristics

  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.

  baseline

• Pelvic Symmetry in Gait

  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.

  baseline

Study Arms (2)

Study group

Women with breast cancer-related lymphedema

Control group

Healthy women

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted at the Oncological Rehabilitation Unit in Gazi University. Women with breast cancer related lymphedema (study group) who were referred to receive physiotherapy recommendations were included in the study.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences

Ankara, Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema; Mobility Limitation

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Physical Therapist

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 8, 2025
• Study Start: April 20, 2025
• Primary Completion: July 20, 2025
• Study Completion: July 25, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)