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

March 20, 2026 updated by: Trak Health Solutions S.L.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Basque Country
      • Donostia / San Sebastian, Basque Country, Spain, 20018
        • Donostia University Hospital (HU Donostia, OSI Donostialdea)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRAK software intervention group
The patients will undergo 4 weeks of treatment using the TRAK platform for shoulder mobility-oriented exercises.
Other: Trak exercise prescription protocol at home
Online exercise protocol using the TRAK software. The patient will undergo 4 weeks of an exercise prescription protocol based on shoulder mobility exercises.
Active Comparator: Paper sheet group
The patients will undergo 4 weeks of treatment using an exercise paper sheet routine to improve shoulder mobility.
Other: Conventional rehabilitation plan at home
Treatment is based on therapeutic exercise following a conventional rehabilitation plan on paper. The patient will undergo 4 weeks of an exercise prescription protocol based on mobility exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder abduction mobility
Time Frame: 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
2-3 days; 15 days; 4-5 and 14 weeks after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder flexion mobility
Time Frame: 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
2-3 days; 15 days; 4-5 and 14 weeks after the surgery
TRAK designed tool satisfaction questionnaire
Time Frame: 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.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trak Health Solutions S.L.

Collaborators

Biogipuzkoa Health Research Institute

Investigators

  • Principal Investigator: Mikel Zabaleta Sistiaga, Donostia University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAK-LINFA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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