Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

NCT06226688 | Completed

• 2 other identifiers: P.T.REC/012/004823202309250044
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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?

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Measure before and after shoulder muscles strength by hand held dynamometer

  Measuring

  6 wweks

Study Arms (2)

Affected arm at the same side of mastectomy

EXPERIMENTAL

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

Procedure: Biofeedback device and other group control group; Procedure: Control group

2 arms one trained by biofeedback and other control without biofeedback

EXPERIMENTAL

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

Procedure: Control group

Interventions

Biofeedback device and other group control group PROCEDURE

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

Also known as: Expirmental trial by biofeedback device

Affected arm at the same side of mastectomy

Control group PROCEDURE

Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc

Also known as: Intervention 2 :- using traditional PT programme without using biofeedback

2 arms one trained by biofeedback and other control without biofeedback; Affected arm at the same side of mastectomy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Nourhan Souliman

Cairo, Bahyea Foundation For Breast Cancer, 02, Egypt

Location

Nourhan Ahmed mahmoud souliman

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Research ethical commity Physical therapy Cairo university

  Research ethical commity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

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

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 26, 2024
• Study Start: October 1, 2023
• Primary Completion: May 5, 2024
• Study Completion: May 9, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

EG (2)