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

NCT06699875 | Completed DMC

• 1 other identifier: TRAK-LINFA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

breast cancer; telerehabilitation; telemedicine; digital health; exercise program; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Shoulder abduction mobility

  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 Outcomes (2)

• Shoulder flexion mobility

  2-3 days; 15 days; 4-5 and 14 weeks after the surgery

• TRAK designed tool satisfaction questionnaire

  14 weeks

Study Arms (2)

TRAK software intervention group

EXPERIMENTAL

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

Other: Trak exercise prescription protocol at home

Paper sheet group

ACTIVE COMPARATOR

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

Other: Conventional rehabilitation plan at home

Interventions

Trak exercise prescription protocol at home OTHER

Online exercise protocol using the TRAK software. The patient will undergo 4 weeks of an exercise prescription protocol based on shoulder mobility exercises.

TRAK software intervention group

Conventional rehabilitation plan at home OTHER

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.

Paper sheet group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trak Health Solutions S.L.: lead
• Biogipuzkoa Health Research Institute: collaborator

Study Sites (1)

Donostia University Hospital (HU Donostia, OSI Donostialdea)

Donostia / San Sebastian, Basque Country, 20018, Spain

Location

Related Publications (24)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mikel Zabaleta Sistiaga

  Donostia University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will not be blinded to patients because masking the use of an application is impossible. However, mobility assessment will be blinded, so the researchers involved in this task will not know the patient group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The allocation of patients to treatment groups will be performed randomly. IIS Biodonostia will generate the randomization list using R software and enter it into REDCap. This ensures that researchers will neither know nor be able to decide which group each study patient will be randomized to. * Control group: The exercise protocol will be completed using printed paper sheets. * Treatment group: The exercise protocol is to be completed using the TRAK tool.

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 21, 2024
• Study Start: May 16, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

ES (1)