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Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06226688
Enrollment
54
Registered
2024-01-26
Start date
2023-10-01
Completion date
2024-05-09
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Brief summary

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?

Detailed description

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

Interventions

PROCEDUREBiofeedback device and other group control group

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

PROCEDUREControl group

Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

RCT 2 groups One of them control group And the other is study group

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure before and after shoulder muscles strength by hand held dynamometer6 wweksMeasuring

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026