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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07542106
Enrollment
40
Registered
2026-04-21
Start date
2026-04-14
Completion date
2026-05-15
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Shoulder Dysfunction

Keywords

Breast Cancer Rehabilitation, Shoulder Dysfunction, Physiotherapy, Biofeedback, Motion Control, Electromyography, Muscle Oxygenation

Brief summary

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

PROCEDUREExperimental 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.

Sponsors

University of Extremadura
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Strength (kg)Baseline and 8 weeksMeasured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation).

Secondary

MeasureTime frameDescription
Range of Motion (degrees)Baseline and 8 weeksMeasured using goniometry (flexion, abduction, internal and external rotation).
Muscle Activity (EMG-microvolts)Baseline and 8 weeksSurface electromyography analysis (RMS-Root mean square, and activation timing of shoulder muscles)
Muscle Oxygen Saturation (SmO₂)Baseline and 8 weeksMeasured using near-infrared spectroscopy (Moxy Monitor).
Handgrip Strength (kg)Baseline and 8 weeksMeasured using a digital dynamometer.
Functional Performance (Sit-to-Stand Test)Baseline and 8 weeksTime required to complete the test.
Fatigue (Piper Fatigue Scale)Baseline and 8 weeksThe 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.
Quality of Life (SF-36 Questionnaire)Baseline and 8 weeksThe 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.

Countries

Spain

Contacts

CONTACTMª Dolores MDAA Apolo-Arenas, PhD
mdapolo@unex.es924489180

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026