An interventional study of Experimental Group: Physiotherapy + Visual Biofeedback in Breast Cancer and Shoulder Dysfunction, sponsored by University of Extremadura. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by University of Extremadura · Not applicable, Interventional, and Treatment
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Extremadura is the lead sponsor of 48 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Experimental Group: Physiotherapy + Visual Biofeedback
Participants will receive a standard physiotherapy program focused on mobility, strengthening, and motor control of the shoulder without 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.
Shoulder Strength (kg)
Measured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation).
Time frame: Baseline and 8 weeks
Range of Motion (degrees)
Measured using goniometry (flexion, abduction, internal and external rotation).
Time frame: Baseline and 8 weeks
Muscle Activity (EMG-microvolts)
Surface electromyography analysis (RMS-Root mean square, and activation timing of shoulder muscles)
Time frame: Baseline and 8 weeks
Muscle Oxygen Saturation (SmO₂)
Measured using near-infrared spectroscopy (Moxy Monitor).
Time frame: Baseline and 8 weeks
Handgrip Strength (kg)
Measured using a digital dynamometer.
Time frame: Baseline and 8 weeks
Functional Performance (Sit-to-Stand Test)
Time required to complete the test.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks
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