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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group: Physiotherapy + Visual Biofeedback | Active Comparator | 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. |
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| Control Group: Conventional Physiotherapy | No Intervention | Participants will receive a standard physiotherapy program focused on mobility, strengthening, and motor control of the shoulder without biofeedback. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group: Physiotherapy + Visual Biofeedback | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Strength (kg) | Measured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation). | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion (degrees) | Measured using goniometry (flexion, abduction, internal and external rotation). | Baseline and 8 weeks |
| Muscle Activity (EMG-microvolts) | Surface electromyography analysis (RMS-Root mean square, and activation timing of shoulder muscles) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mª Dolores MDAA Apolo-Arenas, PhD | Contact | 924489180 | mdapolo@unex.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Mecina y Ciencias de la Salud | Recruiting | Badajoz | Badajoz | 06006 | Spain |
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| Baseline and 8 weeks |
| Muscle Oxygen Saturation (SmO₂) | Measured using near-infrared spectroscopy (Moxy Monitor). | Baseline and 8 weeks |
| Handgrip Strength (kg) | Measured using a digital dynamometer. | Baseline and 8 weeks |
| Functional Performance (Sit-to-Stand Test) | Time required to complete the test. | Baseline and 8 weeks |
| Fatigue (Piper Fatigue Scale) | The Piper Fatigue Scale (PFS) (revised) is scored by calculating averages on a numerical scale of 0 to 10 to measure the intensity and impact of fatigue on patients. Higher scores indicate higher levels of fatigue. | Baseline and 8 weeks |
| Quality of Life (SF-36 Questionnaire) | The SF-36 questionnaire measures health-related quality of life in eight dimensions, where higher scores (0-100) indicate better health. It evaluates physical functioning, pain, general health, vitality, social functioning and mental health. | Baseline and 8 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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