Идёт набор NCT07542106

Effectiveness of a Visual Biofeedback Program Versus Conventional Physiotherapy on Shoulder Mobility, Strength, and Function in Women After Breast Cancer Surgery

Без фазы С лечением Breast Cancer Shoulder Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Experimental Group: Physiotherapy + Visual Biofeedback.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Shoulder Dysfunction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to evaluate the effectiveness of a physiotherapy program incorporating visual biofeedback compared to a conventional physiotherapy program in improving shoulder function in women following breast cancer surgery. Breast cancer survivors frequently experience shoulder dysfunction, including reduced range of motion, decreased strength, altered neuromuscular activity, and impaired scapulohumeral control. While conventional physiotherapy is effective, there is growing interest in interventions targeting motor control and neuromuscular coordination through biofeedback strategies. Participants will be randomly assigned to either a control group receiving conventional physiotherapy or an experimental group receiving the same program supplemented with visual biofeedback using the MotionGuidance system. Outcomes will include shoulder strength, range of motion, functional performance, electromyographic activity, and muscle oxygen saturation.

Подробное описание

Breast cancer is the most common malignancy among women worldwide, with increasing survival rates. However, many survivors experience long-term musculoskeletal complications, particularly affecting the shoulder complex. These include reduced mobility, altered neuromuscular activation, scapular dyskinesis, and functional limitations.

Conventional physiotherapy interventions focusing on mobility, strengthening, and motor control are widely used and supported by evidence. However, there is considerable heterogeneity in treatment protocols and limited research exploring neuromuscular adaptations using objective measures such as electromyography (EMG) and near-infrared spectroscopy (NIRS).

Visual biofeedback interventions, such as MotionGuidance, may enhance motor learning, movement accuracy, and adherence by providing real-time external feedback. Despite their potential, few clinical trials have compared biofeedback-based rehabilitation with standard physiotherapy in breast cancer populations.

This randomized controlled trial will compare two interventions over 8 weeks: (1) conventional physiotherapy and (2) conventional physiotherapy combined with visual biofeedback. Both groups will receive identical treatment dosage, differing only in the use of biofeedback.

The study also incorporates objective neuromuscular and metabolic assessments, including EMG and muscle oxygen saturation (SmO₂), to better understand the mechanisms underlying rehabilitation outcomes.

Вмешательства

Процедура Experimental Group: Physiotherapy + Visual Biofeedback
Participants will receive a structured physiotherapy program combined with visual biofeedback using the MotionGuidance system. The intervention includes guided exercises with laser-based visual feedback to improve motor control and movement accuracy.

Первичные конечные точки

Shoulder Strength (kg) [Срок оценки: Baseline and 8 weeks]

Вторичные конечные точки (7)

Range of Motion (degrees) [Срок оценки: Baseline and 8 weeks]
Muscle Activity (EMG-microvolts) [Срок оценки: Baseline and 8 weeks]
Muscle Oxygen Saturation (SmO₂) [Срок оценки: Baseline and 8 weeks]
Handgrip Strength (kg) [Срок оценки: Baseline and 8 weeks]
Functional Performance (Sit-to-Stand Test) [Срок оценки: Baseline and 8 weeks]
Fatigue (Piper Fatigue Scale) [Срок оценки: Baseline and 8 weeks]
Quality of Life (SF-36 Questionnaire) [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

Women aged 18 years or older
History of breast cancer surgery (mastectomy or breast-conserving surgery within the last 6 months)
Presence of shoulder pain, reduced range of motion, strength deficit, or functional limitation
Ability to understand and follow study instructions