- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06602180
Scapular PNF and Activity Oriented Antiedema Proprioceptive Therapy on Shoulder Dysfunction Post Matectomy Lymphedema
Scapular Proprioceptive Neuromuscular Facilitation and Activity Oriented Antiedema Proprioceptive Therapy on Shoulder Dysfunction Post Matectomy Lymphedema
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Scapular PNF technique, (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT).
- Other: Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT))
- Other: Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)
Detailed Description
In this study the patients will be randomly assigned into three groups (Thirty - one patient for each group):
Group (A):
Thirty-one patients will receive: Scapular PNF technique, Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT).
Group (B):
Thirty-one patients will receive Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT))
Group (C):
Thirty-one patients will receive Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)
.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 2222
- Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The subject selection will be according to the following criteria:
- Age range between 40-60 years.
- Only female patients will participate in the study.
- All female patients diagnosed as unilateral breast cancer.
- All Female patients operated on for BC with BCRL in stages I and II.
- All female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema.
- All patients enrolled to the study will have their informed consent.
Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
- Patients with health problems, diseases or dysfunctions that prevented them from participating in the intervention.
- Patients with bilateral lymphedema.
- Patients with previous primary lymphedema.
- Patients with metastasis.
- Patients whom staging was not possible due to atypical findings or poor image.
- Patients with active arm 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: Exprimental group A
Thirty-one patients will receive: Scapular PNF technique, (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (CDT).
|
Complex or combined decongestive physical therapy (CDT): skin care and patient education, manual lymphatic drainage MLD, joints exercises, and compression garments. Scapular PNF: Proprioceptive Neuromuscular Facilitation (PNF) is treatment approach that focus on motor learning, helps the patient to relax, improves coordination, and normalizes the motion. The repeated contractions technique increases active range of motion and strength and guides the patient's motion towards the desired motion, TAPA involves an intervention protocol composed of: 10-min neuro dynamics oriented to the activity 10-min proprioceptive neuromuscular facilitation activities. 10-min proprioceptive anti-edema bandaging, including patient and/or caretaker instructions for placement, as well as assistance on techniques to use for performing everyday activities, |
|
Experimental: Experimental: group B
Thirty-one patients will receive Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT))
|
Proprioceptive Neuromuscular Facilitation (PNF) is treatment approach that focus on motor learning, helps the patient to relax, improves coordination, and normalizes the motion. The repeated contractions technique increases active range of motion and strength and guides the patient's motion towards the desired motion, Complex or combined decongestive physical therapy (CDT): skin care and patient education, manual lymphatic drainage MLD, joints exercises, and compression garments |
|
Experimental: Experimental: group C:
Thirty-one patients will receive Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)
|
Activity-Oriented Proprioceptive Antiedema Therapy TAPA: TAPA involves an intervention protocol composed of:
Complex or combined decongestive physical therapy (CDT): skin care and patient education, manual lymphatic drainage MLD, joints exercises, and compression garments |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cone formula for lymphedema assessment
Time Frame: three months
|
the truncated cone formula.
V = h C12 + C1C2 + C22 =12 (where V = extremity volume, h = height, C1 = circumference of the top of the cone, C2 = circumference of the base of the cone) as both extremities will be measured from the wrist to the top of the arm (axillary fold) at 4-cm intervals
|
three months
|
|
Digital inclinometer for scapular range and shoulder range assessment
Time Frame: three months
|
The digital inclinometer demonstrates moderate to excellent reliability in evaluating both shoulder and scapular range in case of shoulder disorder
|
three months
|
|
Upper limb function/activity performance: Measured with e Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH):
Time Frame: three months
|
The arm, shoulder, and hand problems quick questionnaire (Quick-Dash) used to evaluate the symptom severity and functional capacity of the patients
|
three months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: rasha ahmed, master, Cairo University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 152427
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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