Skip to content

The Relationship Between Gait Parameters and Balance Disorder and Fall Risk in Breast Cancer-Related Lymphedema(BCRL)

The Relationship Between Gait Parameters and Balance Disorder and Fall Risk in Breast Cancer-Related Lymphedema (BCRL)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07420725
Acronym
BCRL
Enrollment
42
Registered
2026-02-19
Start date
2026-02-05
Completion date
2026-07-10
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Lymphedema

Brief summary

In this study, researchers aimed to evaluate walking function, balance, and fall risk in patients with breast cancer-related lymphedema. The researchers' hypothesis is that balance and walking functions are affected due to a shift in the center of gravity in patients with breast cancer-related lymphedema, and that the risk of falls is increased in the patient population compared to the control group.

Detailed description

In this study, researchers aimed to evaluate walking function, balance, and fall risk in patients with breast cancer-related lymphedema. The researchers' hypothesis is that balance and walking functions are affected due to a shift in the center of gravity in patients with breast cancer-related lymphedema, and that the risk of falls is increased in the patient population compared to the control group.

Interventions

None listed

Sponsors

Kayseri City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Women aged 18-65 with breast cancer-related ISL Stage 2-3 unilateral upper extremity breast cancer-related lymphedema * Healthy female control group matched for age and gender with the patient group aged 18-65 * Participants who agreed to participate in the study and provided written consent

Exclusion criteria

* Presence of underlying diseases that may affect extremity volume other than lymphedema * Presence of phleboedema, lipedema, cellulitis, lymphocele * Presence of acute infection * Presence of acute/chronic lung disease (history of acute pulmonary embolism, acute bronchial asthma attack, chronic interstitial lung disease) * Chronic liver failure * Renal dysfunction * Uncontrolled hypertension and diabetes mellitus * Presence of orthopedic diseases that may impede walking (joint limitation, ankylosis, amputation) * Patients who refused to participate in the study * Patients who lacked cooperation and compliance

Design outcomes

Primary

MeasureTime frameDescription
Gait analysis01 January 2026- 10 July 2026The individual's walking performance will be measured using standard methods employed in clinical assessments and gait analysis studies. Measurements will be conducted in our clinic using the Zebris FDM 2 gait analysis system, and evaluations carried out with different measurement units will be reported as separate outcome criteria.
The Fullerton Advanced Balance Scale (FAB-Scale)01 January 2026- 10 July 2026The FAB Scale is a performance-based test that assesses functional balance (static and dynamic). Functional balance includes static and dynamic components such as the body's overall balance ability, muscle coordination, proprioception, range of motion, muscle strength, and flexibility.
Modified Fall Effectiveness Scale (MFES)01 January 2026- 10 July 2026The MFES is a self-report scale used to assess individuals' levels of fear of falling while performing various daily life activities. An adaptation of the Tinetti Fall Activity Scale (FES), the MFES aims to improve cultural adaptability by more comprehensively evaluating social and environmental factors.
Quick-DASH (Q-DASH)01 ocak 2026- 10 temmuz 2026The Q-DASH consists of 11 items derived from the DASH questionnaire to measure physical function and symptoms of the upper extremity. This index assesses the difficulties patients have experienced in daily living activities over the past week using a 5-point Likert scale. At least 10 out of 11 items must be answered to calculate the Q-DASH score. All items in the questionnaire are scored between 1 and 5. A score of 1 indicates no difficulty during the activity, while a score of 5 indicates complete inability to perform the activity. The Q-DASH has been found to be valid and reliable for assessing upper extremity activity limitations in breast cancer patients.
LYMQO-Arm Index01 January 2026- 10 July 2026The LYMQOL Arm Index is a tool that measures the impact of lymphedema on arm function and assesses its effects on quality of life. It measures the effects on arm function, psychological health, social interactions, and physical symptoms. The index allows monitoring of arm swelling, pain, limitations in movement, and the impact of these effects on psychological and social life.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORFatma G Ülkü Demir, baş araştırmacı

Kayseri City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026