Effectiveness of a Visual Biofeedback Program Versus Conventional Physiotherapy on Shoulder Mobility, Strength, and Function in Women After Breast Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Group: Physiotherapy + Visual Biofeedback.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Shoulder Dysfunction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Procedure 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.
Primary outcome measures
- Shoulder Strength (kg) [Time frame: Baseline and 8 weeks]
Secondary outcome measures (7)
- Range of Motion (degrees) [Time frame: Baseline and 8 weeks]
- Muscle Activity (EMG-microvolts) [Time frame: Baseline and 8 weeks]
- Muscle Oxygen Saturation (SmO₂) [Time frame: Baseline and 8 weeks]
- Handgrip Strength (kg) [Time frame: Baseline and 8 weeks]
- Functional Performance (Sit-to-Stand Test) [Time frame: Baseline and 8 weeks]
- Fatigue (Piper Fatigue Scale) [Time frame: Baseline and 8 weeks]
- Quality of Life (SF-36 Questionnaire) [Time frame: Baseline and 8 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Presence of metastasis
- Post-surgical complications contraindicating exercise
- Severe lymphedema (Stage III or IV)
- Neurological disorders affecting the upper limb
- Severe musculoskeletal shoulder conditions unrelated to breast cancer
- Participation in other rehabilitation programs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Facultad de Mecina y Ciencias de la Salud — Badajoz
Identifiers
NCT: NCT07542106 · 140426