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

April 14, 2026 updated by: Alejandro Caña Pino, University of Extremadura

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mª Dolores MDAA Apolo-Arenas, PhD
  • Phone Number: 924489180
  • Email: mdapolo@unex.es

Study Locations

  • Spain
    • Badajoz
      • Badajoz, Badajoz, Spain, 06006
        • Recruiting
        • Facultad de Mecina y Ciencias de la Salud
        • Contact:
          • Mª Dolores MD Apolo-Arenas, PhD
          • Phone Number: 924489180
          • Email: mdapolo@unex.es
        • Principal Investigator:
          • Alejandro ACP Caña-Pino, PhD
        • Principal Investigator:
          • Carmen CCG Cabanillas García de la Trenada
        • Principal Investigator:
          • Cesar Luís CDM Díaz Muñoz, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
No Intervention: Control Group: Conventional Physiotherapy
Participants will receive a standard physiotherapy program focused on mobility, strengthening, and motor control of the shoulder without biofeedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Strength (kg)
Time Frame: Baseline and 8 weeks
Measured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation).
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion (degrees)
Time Frame: Baseline and 8 weeks
Measured using goniometry (flexion, abduction, internal and external rotation).
Baseline and 8 weeks
Muscle Activity (EMG-microvolts)
Time Frame: Baseline and 8 weeks
Surface electromyography analysis (RMS-Root mean square, and activation timing of shoulder muscles)
Baseline and 8 weeks
Muscle Oxygen Saturation (SmO₂)
Time Frame: Baseline and 8 weeks
Measured using near-infrared spectroscopy (Moxy Monitor).
Baseline and 8 weeks
Handgrip Strength (kg)
Time Frame: Baseline and 8 weeks
Measured using a digital dynamometer.
Baseline and 8 weeks
Functional Performance (Sit-to-Stand Test)
Time Frame: Baseline and 8 weeks
Time required to complete the test.
Baseline and 8 weeks
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.
Baseline and 8 weeks
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.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Extremadura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Actual)

April 14, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140426

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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