Breast Cancer Related LymphedemaNCT07011277
Gait Characteristics of Women With Breast Cancer-Related Lymphedema
An observational study of Breast Cancer Related Lymphedema, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Related Lymphedema
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 25 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Having breast cancer related lymphedema
- Being between the ages of 25-70
- Completing cancer treatments
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences
Ankara, Ankara, 06490
About this study
Official title: Investigation of Gait Characteristics in 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.
- Conditions
- Breast Cancer Related Lymphedema
- Keywords
- breast cancer, lymphedema, gait disorders, upper extremity disorders
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms, Lymphedema, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Women with breast cancer-related lymphedema | |
| Control group | Healthy women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start20 Apr 2025
- Primary completion20 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Related LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Keser, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011277
- Sponsor's protocol ID
- Breast Cancer-Gait Analysis
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No