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NCT Number: NCT07420725

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gait analysis

    Time frame: 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.

  2. The Fullerton Advanced Balance Scale (FAB-Scale)

    Time frame: 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.

  3. Modified Fall Effectiveness Scale (MFES)

    Time frame: 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.

  4. Quick-DASH (Q-DASH)

    Time frame: 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.

  5. LYMQO-Arm Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

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

Acronym: BCRL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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