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

Trak Health Solutions S.L.

Status: Enrolling

Conditions: Breast Cancer Female

Treatments: Other: Conventional rehabilitation plan at home; Other: Trak exercise prescription protocol at home

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06699875

TRAK-LINFA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

TRAK software intervention group

Experimental group

Description:

The patients will undergo 4 weeks of treatment using the TRAK platform for shoulder mobility-oriented exercises.

Treatment:

Other: Trak exercise prescription protocol at home

Paper sheet group

Active Comparator group

Description:

The patients will undergo 4 weeks of treatment using an exercise paper sheet routine to improve shoulder mobility.

Treatment:

Other: Conventional rehabilitation plan at home