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NCT Number: NCT07542106

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Shoulder Dysfunction Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Mecina y Ciencias de la Salud

Badajoz, 06006, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Shoulder Strength (kg)

    Time frame: Baseline and 8 weeks

    Measured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation).

Secondary outcomes

  1. Range of Motion (degrees)

    Time frame: Baseline and 8 weeks

    Measured using goniometry (flexion, abduction, internal and external rotation).

  2. Muscle Activity (EMG-microvolts)

    Time frame: Baseline and 8 weeks

    Surface electromyography analysis (RMS-Root mean square, and activation timing of shoulder muscles)

  3. Muscle Oxygen Saturation (SmO₂)

    Time frame: Baseline and 8 weeks

    Measured using near-infrared spectroscopy (Moxy Monitor).

  4. Handgrip Strength (kg)

    Time frame: Baseline and 8 weeks

    Measured using a digital dynamometer.

  5. Functional Performance (Sit-to-Stand Test)

    Time frame: Baseline and 8 weeks

    Time required to complete the test.

  6. Fatigue (Piper Fatigue Scale)

    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.

  7. Quality of Life (SF-36 Questionnaire)

    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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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