NCT07542106

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
0mo left

Started Apr 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Apr 2026May 2026

First Submitted

Initial submission to the registry

April 14, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

Breast Cancer RehabilitationShoulder DysfunctionPhysiotherapyBiofeedbackMotion ControlElectromyographyMuscle Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Shoulder Strength (kg)

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

    Baseline and 8 weeks

Secondary Outcomes (7)

  • Range of Motion (degrees)

    Baseline and 8 weeks

  • Muscle Activity (EMG-microvolts)

    Baseline and 8 weeks

  • Muscle Oxygen Saturation (SmO₂)

    Baseline and 8 weeks

  • Handgrip Strength (kg)

    Baseline and 8 weeks

  • Functional Performance (Sit-to-Stand Test)

    Baseline and 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Experimental Group: Physiotherapy + Visual Biofeedback

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Mecina y Ciencias de la Salud

Badajoz, Badajoz, 06006, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Mª Dolores MDAA Apolo-Arenas, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start

April 14, 2026

Primary Completion

April 14, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations