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临床试验/NCT07420725
NCT07420725
尚未招募
不适用

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

Kayseri City Hospital0 个研究点目标入组 42 人开始时间: 2026年2月5日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Kayseri City Hospital
入组人数
42
主要终点
Gait analysis

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

结局指标

主要结局

Gait analysis

时间窗: 01 January 2026- 10 July 2026

These are biomechanical and spatiotemporal variables measured to evaluate an individual's gait. These parameters are used in both clinical assessments and gait analysis studies. In our clinic, gait parameters will be evaluated using the Zebris FDM 2 gait scanner.

The Fullerton Advanced Balance Scale (FAB-Scale)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fatma Gül Ülkü Demir

BAŞASİSTAN UZMAN DOKTOR

Kayseri City Hospital

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