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临床试验/NCT06036173
NCT06036173已完成不适用

Effects of Lymphedema After Breast Cancer Treatment on Body Awareness and Upper Extremity Functionality

Selcuk University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire

研究概览

简要总结

To determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • first group:
  • being female,
  • being aged 18-65 years,
  • having undergone unilateral breast cancer surgery,
  • being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
  • not having any orthopedic disease that would prevent walking, and volunteering to participate in the study.
  • second group:The inclusion criteria for the breast cancer surgery group
  • without lymphedema were being female,
  • being aged 18-65 years,
  • having undergone unilateral breast cancer surgery, and volunteering to participate in the study.
  • Lastly, the inclusion criteria for the control group were:
  • being female,
  • being aged 18-65 years,
  • having no history of cancer surgery, and volunteering to participate in the study.

排除标准

  • for all groups
  • not being willing to participate in the study;
  • the presence of metastases, neurological, or orthopedic disorders;
  • postural deformities, such as scoliosis and kyphosis;
  • mental and cognitive disorders; or communication/cooperation problems

结局指标

主要结局

Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire

时间窗: 11 minutes

Each of the 11 items in this instrument is scored from 1 to 5. The responses given to all items are summed up, and the total score is obtained with a special formula. A high total score indicates a high level of functional limitation. Max/ min score: 100/0

Body Awareness Questionnaire

时间窗: 17 minutes

This instrument consists of a total of 18 items evaluated based on a scale of 1 (not at all true of me) to 7 (very true of me). The total score is obtained by adding the scores of each item. A higher total score indicates better body awareness. Max/ min score:126/18

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine Cihan

Assist. Prof.

Selcuk University

研究点 (1)

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