- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06602180
Scapular PNF and Activity Oriented Antiedema Proprioceptive Therapy on Shoulder Dysfunction Post Mastectomy Lymphedema
Scapular Proprioceptive Neuromuscular Facilitation and Activity Oriented Antiedema Proprioceptive Therapy on Shoulder Dysfunction Post Mastectomy Lymphedema
Eighty -four female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema, will Cairo University hospitals be randomly distributed into three groups equal in number.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Otro: Scapular PNF technique, (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT).
- Otro: Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)
- Otro: Scapular proprioceptive neuromuscular facilitation PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)
Descripción detallada
In this study the patients will be randomly assigned into three groups ( Twenty-eight patient for each group):
Group (A):
Twenty-eight 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):
Twenty-eight 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)
Group (C):
Twenty-eight patients will receive Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of Complex decongestive therapy (CDT)
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Cairo, Egipto, 2222
- Faculty of Physical Therapy
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
The subject selection will be according to the following criteria:
- Age range between 40-65 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Exprimental group A
Twenty-eight 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
Twenty-eight 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 |
|
Experimental: Experimental: group C:
Twenty-eight 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cone formula for lymphedema assessment
Periodo de tiempo: 6 weeks
|
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 |
6 weeks
|
|
Digital inclinometer for scapular range and shoulder range assessment
Periodo de tiempo: 6 weeks
|
The digital inclinometer demonstrates moderate to excellent reliability in evaluating both shoulder and scapular range in case of shoulder disorder |
6 weeks
|
|
Upper limb function/activity performance: Measured with e Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH):
Periodo de tiempo: 6 weeks
|
The arm, shoulder, and hand problems quick questionnaire (Quick-Dash) used to evaluate the symptom severity and functional capacity of the patients |
6 weeks
|
|
Hand grip assessment : Measured with hand grip dynamometer
Periodo de tiempo: 6 weeks
|
A hand grip dynamometer is a, typically electronic,, device used to measure maximum isometric grip strength, acting as a key tool for health assessments |
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: rasha ahmed, master, Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 152427
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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