- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: İdil Esin Ünlü, Assist. Prof. Dr.
- Número de telefone: +90 506 515 66 22
- E-mail: idil.unlu@toros.edu.tr
Locais de estudo
-
-
-
Adana, Turquia (Türkiye)
- Recrutamento
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Contato:
- Deniz TUNCA, PT
- Número de telefone: +90 532 409 36 33
- E-mail: denizcanoglu82@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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.
|
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Upper Extremity Function
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment
|
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.
|
Baseline, immediately after completion of treatment, and 2 months after treatment
|
|
Change in Head Anterior Translation
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment
|
Head anterior translation will be assessed using the PostureScreen mobile application.
|
Baseline, immediately after completion of treatment, and 2 months after treatment
|
|
Change in Shoulder Height Asymmetry
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment.
|
Shoulder height asymmetry will be assessed using the PostureScreen mobile application.
|
Baseline, immediately after completion of treatment, and 2 months after treatment.
|
|
Change in Shoulder Anterior Translation
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment.
|
Shoulder anterior translation will be assessed using the PostureScreen mobile application.
|
Baseline, immediately after completion of treatment, and 2 months after treatment.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Scapular Muscle Strength
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment
|
Scapular muscle strength (upper, middle, and lower trapezius muscles) will be measured using a handheld dynamometer (MicroFET2) with the isometric make-test method.
|
Baseline, immediately after completion of treatment, and 2 months after treatment
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 25.02.2026-1214/23
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Complex Decongestive Therapy
-
Pamukkale UniversityConcluído
-
University of PennsylvaniaRescindidoInfecção Recorrente por Clostridium DifficileEstados Unidos
-
Fabio Correia SampaioConcluídoCáries dentáriasBrasil
-
Azienda Ospedaliera Universitaria Integrata VeronaConcluído
-
Karadeniz Technical UniversityInscrevendo-se por convite
-
Eskisehir Osmangazi UniversityEskisehir Osmangazi University Training and Research HospitalConcluídoTratamento da dor | Recuperação de Oócitos | Gerenciamento de ansiedadePeru
-
Haydarpasa Numune Training and Research HospitalAlmediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited SirketiAinda não está recrutandoFibromialgia | Síndrome de FibromialgiaTurquia (Türkiye)
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale...Concluído
-
University of Roma La SapienzaConcluídoFalha no implante dentário | Mucosite OralItália
-
CellMedX CorporationNutrasource Pharmaceutical and Nutraceutical Services, Inc.Concluído