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临床试验/NCT06226688
NCT06226688已完成不适用

Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

Cairo University4 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年10月1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
54
试验地点
4
主要终点
Measure before and after shoulder muscles strength by hand held dynamometer

研究概览

简要总结

PURPOSE:The purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy.

BACKGROUND:

  • The most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (UL), reduced range of motion (ROM) of the shoulder, flexion and abduction is limited to 90°, and external rotation is limited to 40°, and there are postural changes
  • One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery
  • Shoulder problems in breast cancer patients affect their daily activities, such as pulling a sweater overhead, fastening a bra, zipping up a back zipper, reaching overhead, and carrying heavy bags.
  • Biofeedback is a mind-body technique in which individuals learn how to modify their physiology for the purpose of improving physical, mental, emotional and spiritual health. Much like physical therapy, biofeedback training requires active participation on the part of patients and often regular practice between training sessions. Clinical biofeedback may be used to manage disease symptoms as well as to improve overall health and wellness through stress management training. Research has shown that biofeedback interventions are efficacious in treating a variety of medical conditions, and many Americans are turning to biofeedback and other less traditional therapies for their (Dana et al., 2010).

HYPOTHESES: null hypothesis

RESEARCH QUESTION: Does biofeedback give effect on shoulder muscles strength post mastectomy?

详细描述

27 patient per group to G power 90% a Inclusion Criteria:

The subject selection will be according to the following criteria:

  • Female patients with age range between 40-60 will participate in the study.
  • All patients with their informed consent.
  • All patients with unilateral mastectomy
  • All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
  • All patients with chemo or radio therapy 1.2.b Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

  • metastasis
  • Psychological Disorder
  • Lymphedema
  • Neurological or musculoskeletal disorders

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The subject selection will be according to the following criteria:
  • Female patients with age range between 40-60 will participate in the study.
  • All patients with their informed consent.
  • All patients with unilateral mastectomy
  • All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
  • All patients with chemo or radio therapy

排除标准

  • The potential participants will be excluded if they meet one of the following criteria:
  • metastasis
  • Psychological Disorder
  • Lymphedema
  • Neurological or musculoskeletal disorders

结局指标

主要结局

Measure before and after shoulder muscles strength by hand held dynamometer

时间窗: 6 wweks

Measuring

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

Nourhan Ahmed Mahmoud Souliman

Demonstrator

Cairo University

研究点 (4)

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