- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Autre: Scapular PNF technique, (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT).
- Autre: Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)
- Autre: Scapular proprioceptive neuromuscular facilitation PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)
Description détaillée
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)
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Cairo, Egypte, 2222
- Faculty of Physical Therapy
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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, |
|
Expérimental: 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 |
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cone formula for lymphedema assessment
Délai: 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
Délai: 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):
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: rasha ahmed, master, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 152427
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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