Conventional Therapy vs. Telerehabilitation With TRAK in Patients Undergoing Axillary Lymph Node Removal

Not Applicable

Recruiting

• Conditions: Breast Cancer Female

• Registration Number: NCT06699875
• Lead Sponsor: Trak Health Solutions S.L.

Brief Summary

The goal of this clinical trial is to compare the effectiveness of digital physiotherapy via Trak telerehabilitation with conventional home-based exercises in women who have undergone axillary lymph node removal (axillary lymphadenectomy) as part of breast cancer treatment.

Researchers will compare the Trak telerehabilitation platform to a standard home exercise protocol to assess the impact on shoulder mobility, treatment adherence, and overall patient satisfaction.

Participants will undergo a 4-week home-based rehabilitation using Trak (treatment group) or follow a paper-based exercise protocol (control group) and attend follow-up visits to measure shoulder mobility and any necessary adjustments in treatment.

Detailed Description

Women undergoing axillary lymph node removal as part of breast cancer therapy will be recruited. All participants will complete a baseline assessment before being randomly assigned (1:1) to the experimental (telerehabilitation) or control (paper-based exercises) group. Throughout the study, all participants will have follow-up assessments at specific intervals:

* Baseline (V0), initial screening: Health assessments, ensuring their individual needs are met, and written informed consent immediately after the intervention.

* 15 Days Post-Assignment (V1): Initial evaluation of shoulder mobility and assessment for factors like scarring, seroma, and auxiliary cord.

* 3-4 Weeks Post-Assignment (V2): Radiation oncology consultation to assess the mobility metrics and determine whether radiotherapy is necessary or if a delay is required.

* 8 weeks Post-Assessment (V3): The healthcare professional will meet to evaluate shoulder abduction in the affected arm. For patients in the Trak group, the professional will access objective rehabilitation data and metrics from the platform.

* 14 Weeks Post-V1 (V3): Final evaluation of shoulder abduction and assessment of functional recovery (mobility level recovered by the patient). It will also be recorded if the patient needs to receive adjuvant chemotherapy (after surgery). The professional will be able to evaluate each patient's evolution, adherence, and condition. During the visit, the patients will respond to a survey on the technique assigned for rehabilitation (either with the exercises or using Trak).

Patients from the experimental group will use the TRAK telerehabilitation platform (https://www.trakphysio.com/es/) at home for 4 weeks. Patients from the control group will follow a paper-based exercise regimen at home for the same time.

Primary outcomes include shoulder abduction and flexion mobility (first and last visit), adherence to the rehabilitation protocol, satisfaction with the Trak platform (internal survey), and the need for adjuvant chemotherapy. Both groups will complete initial and final assessments on paper, and data will be analyzed for efficacy, adherence, and patient satisfaction.

Study Timeline

• Study Start: 2023-05-16
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder abduction mobility	2-3 days; 15 days; 4-5 and 14 weeks after the surgery	Active shoulder abduction the patient is able to do actively measurded with a goniometer

Secondary Outcome Measures

Name	Time	Method
Shoulder flexion mobility	2-3 days; 15 days; 4-5 and 14 weeks after the surgery	Active shoulder abduction the patient is able to do actively measurded with a goniometer
TRAK designed tool satisfaction questionnaire	14 weeks	The trak satisfaction questionnaire was provided to patients in Spanish and consists of 12 questions about usability, usefulness and satisfaction as well as a suggestions section at the end. The score ranges from 0 to 12, with 0 being no satisfaction and 12 being a maximum level of satisfaction.

Trial Locations

Locations (1)

Donostia University Hospital (HU Donostia, OSI Donostialdea); 🇪🇸 San Sebastián, País Vasco, Spain