Comparing digital physiotherapy with traditional exercises for breast cancer patients after lymph node removal
Comparative Study of the Effectiveness Between Models of Conventional Therapy vs Telerehabilitation With TRAK in Patients Undergoing Axillary Lymph Node Removal (Axillary Lymphadenectomy) as Part of Therapy Against Breast Cancer.
This study tests if a digital physiotherapy program can help women recover better after breast cancer surgery compared to traditional home exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Trak Health Solutions S.L. Industry-sponsored |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (San Sebastián, País Vasco) |
| Trial ID | NCT06699875 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of telerehabilitation using the Trak platform against conventional home-based exercise protocols in women who have undergone axillary lymph node removal as part of breast cancer treatment. Participants will be randomly assigned to either the telerehabilitation group or the control group, with assessments conducted at various intervals to measure shoulder mobility, treatment adherence, and patient satisfaction. The study will involve a 4-week rehabilitation period, followed by multiple follow-up evaluations to track recovery and functional outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are undergoing axillary lymph node removal as part of their breast cancer treatment and can use electronic devices.
Not a fit: Patients with cognitive restrictions, those receiving adjuvant chemotherapy, or individuals with prior shoulder-limiting conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation outcomes and patient satisfaction for women recovering from breast cancer surgery.
How similar studies have performed: Other studies have shown promising results with telerehabilitation approaches, indicating potential success for this novel application in breast cancer recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients equal to or older than 18 years old. * Patient undergoing axillary lymph node removal (axillary lymphadenectomy) as part of breast cancer therapy. * Patients with a tablet, smartphone, or laptop who can use electronic devices (or with family support). * Patient with an e-mail account (or willing to generate a new one). * Signed the informed consent. Exclusion Criteria: * Patient with cognitive restriction * Patient receiving adjuvant chemotherapy (after lymphadenectomy) * Patient with previous shoulder-limiting pathology (cuff tear, chronic pain, shoulder fracture with sequelae of limited mobility) * Patient who has undergone previous surgery on the same shoulder.
Where this trial is running
San Sebastián, País Vasco
- Donostia University Hospital (HU Donostia, OSI Donostialdea) — San Sebastián, País Vasco, Spain (Recruiting)
Study contacts
- Principal investigator: Mikel Zabaleta Sistiaga — Donostia University Hospital
- Study coordinator: Juan F Duarte Mendoza
- Email: juanfernando@trak.es
- Phone: +34 677 33 4869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.