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Clinical Trials in Turkey / NCT07420725
Active, not recruiting Observational

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

NCT07420725 · tracked via the Priya Life Science Turkey tracker
Sponsor
Kayseri City Hospital
Phase
Observational
Started
2026-02-05
Last updated
2026-04-09

Condition(s) studied

Breast Cancer Lymphedema

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Gait analysis — 01 January 2026- 10 July 2026
    The 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 2026
    The 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 2026
    The 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 2026
    The 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 Index — 01 January 2026- 10 July 2026
    The 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.

Trial sites (1)

FacilityCityRegionStatus
Kayseri City Hospital Kayseri Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07420725 on ClinicalTrials.gov ↗ ← All trials in Turkey