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

NCT07420725 | Active Not Recruiting DMC

• 1 other identifier: BCRL
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (5)

• Gait analysis

  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.

  01 January 2026- 10 July 2026

• The Fullerton Advanced Balance Scale (FAB-Scale)

  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.

  01 January 2026- 10 July 2026

• Modified Fall Effectiveness Scale (MFES)

  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.

  01 January 2026- 10 July 2026

• Quick-DASH (Q-DASH)

  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.

  01 ocak 2026- 10 temmuz 2026

• LYMQO-Arm Index

  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.

  01 January 2026- 10 July 2026

Study Arms (2)

Patient group

Female patients aged 18-65 years who are evaluated for upper extremity swelling after breast cancer surgery and/or radiation therapy and diagnosed with BRCL

Control group

Patient group aged 18-65 and age and gender-matched healthy female control group.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women aged 18-65 with unilateral upper extremity lymphedema associated with breast cancer.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients aged 18-65 years who presented to the Lymphedema outpatient clinic of the Physical Medicine and Rehabilitation Department at Kayseri City Hospital with upper extremity swelling following breast cancer surgery and/or radiation therapy and were diagnosed with BRCL (Group 1: LG, lymphedema group) will be included in the study. The control group (Group 2: KG) will consist of age- and gender-matched volunteer participants who presented to the Physical Medicine and Rehabilitation outpatient clinics with non-specific pain complaints and who did not have any postural, neurological, or orthopedic disorders.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatma G Ülkü Demir, baş araştırmacı

  Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BAŞASİSTAN UZMAN DOKTOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

TU (1)