Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

NCT ID: NCT06226688

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-05-09

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

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Affected arm at the same side of mastectomy

There is 2 arms Arm1:-arm at side of mastectomy without lymphedema trained by biofeedback

Group Type: EXPERIMENTAL

Biofeedback device and other group control group

Intervention Type: PROCEDURE

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

Control group

Intervention Type: PROCEDURE

Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc

2 arms one trained by biofeedback and other control without biofeedback

Arm2:-arm at side of mastectomy on other group but not trained with biofeedback Training using shoulder ladder ,shoulder wheel ,shoulder mobilization and IPC

Group Type: EXPERIMENTAL

Control group

Intervention Type: PROCEDURE

Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc

Interventions

Biofeedback device and other group control group

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

Intervention Type: PROCEDURE

Control group

Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc

Intervention Type: PROCEDURE

Other Intervention Names

Expirmental trial by biofeedback device; Intervention 2 :- using traditional PT programme without using biofeedback

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Ahmed Mahmoud Souliman

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Research ethical commity Physical therapy Cairo university

Role: PRINCIPAL_INVESTIGATOR

Research ethical commity

Locations

Nourhan Souliman

Cairo, Bahyea Foundation For Breast Cancer, Egypt

Nourhan Ahmed mahmoud souliman

Cairo, , Egypt

Countries

Egypt

Other Identifiers

202309250044

Identifier Type: REGISTRY

Identifier Source: secondary_id

P.T.REC/012/004823

Identifier Type: -

Identifier Source: org_study_id