- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06701591
Kinesio-Taping and Chest Physiotherapy Program After Mastectomy
Efficacy of Combined Kinesio-Taping With Chest Physiotherapy Program on Pain, Pulmonary Function, Respiratory Muscle Strength and Quality of Life After Mastectomy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 1124
- Faculty of physical therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females aged between 30 and 50 years
- Participants after modified radical mastectomy
- Participants able to comprehend instructions.
- Cooperative participants, and willing to participate in the study.
Exclusion Criteria:
- Participants having sensitive skin, scars, or lesions.
- Participants with unhealed incisions at the site of application.
- Participants with uncontrolled diabetes.
- Participants with deep vein thrombosis.
- Participants with previous chest diseases.
- Pregnancy.
- Participants with altered sensations.
- Participants with allodynia.
- Participants with active infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Kinesiotaping group)
Participants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%. Additionally, traditional physical therapy program will be conducted to participants in the study group. |
Participants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension.
In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%.
The chest physical therapy program is consisted of deep breathing exercises, postural drainage, and cough.
|
|
Active Comparator: Group B (control group)
They will receive the chest physical therapy program which is consisted of deep breathing exercises, postural drainage, cough, 3 times /week for 4 weeks.
|
The chest physical therapy program is consisted of deep breathing exercises, postural drainage, and cough.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analogue scale
Time Frame: 4 weeks
|
The visual representation of the pain range that a patient thinks they might experience is called a linear scale.
The score is ranged from 0 to 10.
The least the score, the better results.
While, the higher the score, the worst the results.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced vital capacity (FVC)
Time Frame: 4 weeks
|
The forced vital capacity (FVC) will be measured by spirometer.
|
4 weeks
|
|
forced expiratory volume at first second (FEV1)
Time Frame: 4 weeks
|
forced expiratory volume at first second (FEV1) will be measured by spirometer.
|
4 weeks
|
|
Forced expiratory volume at first second /Forced vital capacity ratio.
Time Frame: 4 weeks
|
Forced expiratory volume at first second /Forced vital capacity ratio will be measured by spirometer.
|
4 weeks
|
|
Respiratory muscle strength
Time Frame: 4 weeks
|
Respiratory muscle strength will be measured by assessing the maximal inspiratory and maximal expiratory pressures (MIP) and maximal expiratory pressures (MEP).
|
4 weeks
|
|
Quality of life
Time Frame: 4 weeks
|
Quality of life will be measured by the Short Form-36 (SF-36).
It is a questionnaire with eight subscales that gives information about the health status and quality of life of the person.
Scores on each subscale range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hadaya M Eladl, PhD, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- No. 6905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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