Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06226688
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-01-14
Brief Title:
Biofeedback Training on Shoulder Muscles Strength Post Mastectomy
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Biofeedback Training on Shoulder Muscles Strength Post Mastectomy
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PURPOSEThe 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
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 12b Exclusion Criteria
The potential participants will be excluded if they meet one of the following criteria
metastasis
Psychological Disorder
Lymphedema
Neurological or musculoskeletal disorders
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 12b Exclusion Criteria
The potential participants will be excluded if they meet one of the following criteria
metastasis
Psychological Disorder
Lymphedema
Neurological or musculoskeletal disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 202309250044 | REGISTRY | Baheya research center | None |