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Completed

NCT Number: NCT06226688

Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

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?

Completed

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Key information

Conditions

Breast Cancer Female

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nourhan Souliman, Cairo, Bahyea Foundation For Breast Cancer, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Exclusion criteria

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

Treatment and study plan

Biofeedback device and other group control group

Procedure

Intervention 1 :-Using the biofeedback device with dumble to strength affected arm post mastectomy

Other names: Expirmental trial by biofeedback device

Control Group

Procedure

Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc

Other names: Intervention 2 :- using traditional PT programme without using biofeedback

Primary outcomes

  1. Measure before and after shoulder muscles strength by hand held dynamometer

    Time frame: 6 wweks

    Measuring

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2024
Registry last updated
Aug 2, 2024

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

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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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