- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07697495
Scapulothoracic Stabilization and Postural Training in Upper Extremity Lymphedema
Effects of Scapulothoracic Stabilization and Postural Training Added to Standard Lymphedema Care on Muscle Strength, Posture and Functional Outcomes in Secondary Upper Extremity Lymphedema: A Single-Center Randomized Controlled Trial
Przegląd badań
Status
Warunki
Szczegółowy opis
Secondary upper extremity lymphedema is a common complication following breast cancer treatment and is characterized by chronic swelling, pain, reduced muscle strength, impaired upper extremity function, and postural alterations. These impairments may negatively affect daily activities, body perception, and quality of life. Although Complex Decongestive Therapy (CDT) is considered the gold standard for lymphedema management, conventional treatment primarily focuses on edema reduction and does not specifically address scapular stability, postural alignment, or neuromuscular control.
Altered scapulothoracic biomechanics and postural dysfunction are frequently observed in individuals with breast cancer-related lymphedema. These impairments may contribute to shoulder dysfunction, muscle weakness, compensatory movement patterns, and persistent functional limitations. Scapulothoracic stabilization exercises aim to restore scapular muscle balance and improve dynamic shoulder stability, whereas postural training promotes optimal alignment and body awareness. The combined application of these interventions may enhance functional recovery beyond the effects of standard CDT alone; however, evidence from randomized controlled trials remains limited.
This single-center, prospective, randomized controlled trial aims to evaluate the effectiveness of adding scapulothoracic stabilization and postural training to standard lymphedema care in women with secondary upper extremity lymphedema following breast cancer surgery. Participants will be randomly allocated to either a control group receiving standard lymphedema care or an intervention group receiving standard care plus scapulothoracic stabilization and postural training. Randomization will be performed using a computer-generated allocation sequence, and all outcome assessments will be conducted by a blinded assessor.
Outcome measures will be collected at baseline, immediately after completion of treatment, and at a 2-month follow-up. Primary and secondary outcomes will include scapular muscle strength measured with a handheld dynamometer (MicroFET2), postural alignment assessed using the PostureScreen application, upper extremity function evaluated with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, limb volume calculated from serial circumference measurements, and neck awareness assessed using the Fremantle Neck Awareness Questionnaire (FreNAQ). The findings of this study are expected to provide evidence regarding the clinical benefits of incorporating targeted scapulothoracic stabilization and postural training into conventional lymphedema rehabilitation and may contribute to the development of more comprehensive rehabilitation protocols for breast cancer survivors.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: İdil Esin Ünlü, Assist. Prof. Dr.
- Numer telefonu: +90 506 515 66 22
- E-mail: idil.unlu@toros.edu.tr
Lokalizacje studiów
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Adana, Turcja (Türkiye)
- Rekrutacyjny
- Adana Şehir Eğitim ve Araştırma Hastanesi
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Kontakt:
- Deniz TUNCA, PT
- Numer telefonu: +90 532 409 36 33
- E-mail: denizcanoglu82@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Female patients aged 18 to 65 years.
- Diagnosed with secondary upper extremity lymphedema following breast cancer surgery (mastectomy).
- Willing to participate in the study.
- Able to provide written informed consent.
Exclusion Criteria:
- Active infection (e.g., cellulitis or lymphangitis).
- Advanced shoulder or cervical pathology.
- Neurological disorders affecting upper extremity function.
- Metastatic disease.
- Receiving active chemotherapy.
- Participation in another intensive lymphedema rehabilitation program within the previous 3 months.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Scapulothoracic Stabilization
Participants assigned to the experimental group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with a structured scapulothoracic stabilization and postural training program.
The additional exercise program is designed to improve scapular muscle function, postural alignment, and upper extremity function.
Assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
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Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
A supervised exercise program consisting of scapulothoracic stabilization exercises and postural training designed to improve scapular muscle strength, postural alignment, and upper extremity function.
The program will be provided in addition to standard Complex Decongestive Therapy throughout the treatment period.
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Aktywny komparator: Control
Participants assigned to the control group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises according to routine clinical practice.
Outcome assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
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Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Upper Extremity Function
Ramy czasowe: Baseline, immediately after completion of treatment, and 2 months after treatment
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Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The DASH is a validated 30-item patient-reported outcome measure evaluating symptoms and functional limitations of the upper extremity.
Scores range from 0 to 100, with higher scores indicating greater disability.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Change in Head Anterior Translation
Ramy czasowe: Baseline, immediately after completion of treatment, and 2 months after treatment
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Head anterior translation will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Change in Shoulder Height Asymmetry
Ramy czasowe: Baseline, immediately after completion of treatment, and 2 months after treatment.
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Shoulder height asymmetry will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment.
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Change in Shoulder Anterior Translation
Ramy czasowe: Baseline, immediately after completion of treatment, and 2 months after treatment.
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Shoulder anterior translation will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Scapular Muscle Strength
Ramy czasowe: Baseline, immediately after completion of treatment, and 2 months after treatment
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Scapular muscle strength (upper, middle, and lower trapezius muscles) will be measured using a handheld dynamometer (MicroFET2) with the isometric make-test method.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 25.02.2026-1214/23
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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