Breast CancerNCT07542106
Effectiveness of a Visual Biofeedback Program Versus Conventional Physiotherapy on Shoulder Mobility, Strength, and Function in Women After Breast Cancer Surgery
A study testing Experimental Group: Physiotherapy + Visual Biofeedback in people with Breast Cancer and Shoulder Dysfunction, run by University of Extremadura at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Shoulder Dysfunction
- What is being tested?
- Experimental Group: Physiotherapy + Visual Biofeedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 14 Apr 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Facultad de Mecina y Ciencias de la Salud
Badajoz, Badajoz, 06006
Mª Dolores MD Apolo-Arenas, PhD, 924489180, mdapolo@unex.es
Alejandro ACP Caña-Pino, PhD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Shoulder Dysfunction
- Being tested
- Experimental Group: Physiotherapy + Visual Biofeedback
- Keywords
- Breast Cancer Rehabilitation, Shoulder Dysfunction, Physiotherapy, Biofeedback, Motion Control, Electromyography, Muscle Oxygenation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group: Physiotherapy + Visual BiofeedbackProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Physiotherapy + Visual Biofeedback | Active comparator | 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. Receives: Procedure: Experimental Group: Physiotherapy + Visual Biofeedback |
| Control Group: Conventional Physiotherapy | No intervention | Participants will receive a standard physiotherapy program focused on mobility, strengthening, and motor control of the shoulder without biofeedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Strength (kg)
Measured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation).
Measured: Baseline and 8 weeks
Secondary outcomes (7)
Range of Motion (degrees)
Measured using goniometry (flexion, abduction, internal and external rotation).
Measured: Baseline and 8 weeks
Muscle Activity (EMG-microvolts)
Surface electromyography analysis (RMS-Root mean square, and activation timing of shoulder muscles)
Measured: Baseline and 8 weeks
Muscle Oxygen Saturation (SmO₂)
Measured using near-infrared spectroscopy (Moxy Monitor).
Measured: Baseline and 8 weeks
Handgrip Strength (kg)
Measured using a digital dynamometer.
Measured: Baseline and 8 weeks
Functional Performance (Sit-to-Stand Test)
Time required to complete the test.
Measured: Baseline and 8 weeks
Fatigue (Piper Fatigue Scale)
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.
Measured: Baseline and 8 weeks
Quality of Life (SF-36 Questionnaire)
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start14 Apr 2026
- Primary completion14 Apr 2026
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542106
- Sponsor's protocol ID
- 140426
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Visual Biofeedback Program Versus Conventional Physiotherapy on Shoulder Mobility, Strength, and Function in Women After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07542106
- Acronym / sponsor ID
- 140426
- Conditions
- Breast Cancer, Shoulder Dysfunction
- Keywords
- Breast Cancer Rehabilitation, Shoulder Dysfunction, Physiotherapy, Biofeedback, Motion Control, Electromyography, Muscle Oxygenation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Physiotherapy + Visual Biofeedback | Active comparator | Procedure: Experimental Group: Physiotherapy + Visual BiofeedbackParticipants 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. |
| Control Group: Conventional Physiotherapy | No intervention | –Participants will receive a standard physiotherapy program focused on mobility, strengthening, and motor control of the shoulder without biofeedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Group: Physiotherapy + Visual BiofeedbackParticipants 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 or surgery | Experimental Group: Physiotherapy + Visual Biofeedback |
Primary outcome
Shoulder Strength (kg)
Time frame: Baseline and 8 weeks
Measured using handheld dynamometry (isometric strength in flexion, abduction, and external rotation).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group: Physiotherapy + Visual Biofeedback in people with Breast Cancer and Shoulder Dysfunction, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mª Dolores MDAA Apolo-Arenas, PhD (924489180, mdapolo@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Strength (kg) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.