NCT Number: NCT07542106
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Badajoz, 06006, Spain
Location status: Recruiting
Alejandro ACP Caña-Pino, PhD
PRINCIPAL_INVESTIGATOR
Carmen CCG Cabanillas García de la Trenada
PRINCIPAL_INVESTIGATOR
Cesar Luís CDM Díaz Muñoz, Phd
PRINCIPAL_INVESTIGATOR
Mª Dolores MD Apolo-Arenas, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline and 8 weeks
Measured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation).
Time frame: Baseline and 8 weeks
Measured using goniometry (flexion, abduction, internal and external rotation).
Time frame: Baseline and 8 weeks
Surface electromyography analysis (RMS-Root mean square, and activation timing of shoulder muscles)
Time frame: Baseline and 8 weeks
Measured using near-infrared spectroscopy (Moxy Monitor).
Time frame: Baseline and 8 weeks
Measured using a digital dynamometer.
Time frame: Baseline and 8 weeks
Time required to complete the test.
Time frame: Baseline and 8 weeks
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
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.
Contact information is provided by the study sponsor or research team.
University of Extremadura
Other
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