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| Name | Class |
|---|---|
| Biogipuzkoa Health Research Institute | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAK software intervention group | Experimental | The patients will undergo 4 weeks of treatment using the TRAK platform for shoulder mobility-oriented exercises. |
|
| Paper sheet group | Active Comparator | The patients will undergo 4 weeks of treatment using an exercise paper sheet routine to improve shoulder mobility. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder flexion 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 |
| TRAK designed tool satisfaction questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikel Zabaleta Sistiaga | Donostia University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donostia University Hospital (HU Donostia, OSI Donostialdea) | Donostia / San Sebastian | Basque Country | 20018 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35500200 | Background | Singleton AC, Raeside R, Hyun KK, Partridge SR, Di Tanna GL, Hafiz N, Tu Q, Tat-Ko J, Sum SCM, Sherman KA, Elder E, Redfern J. Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses. J Clin Oncol. 2022 Jul 10;40(20):2257-2270. doi: 10.1200/JCO.21.01171. Epub 2022 May 2. | |
| 34287208 | Background |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
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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.
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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.
| 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. |
|
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 |
| Mahmoud IAM Sr. Usability of Telemedicine in Physical Therapy Rehabilitation: Systematic review. JMIR Rehabil Assist Technol. 2021 Jun 3. doi: 10.2196/25250. Online ahead of print. |
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| Background | Servicios | EJIE. (s. f.). Basque Administration Web Portal. Recuperado 27 de octubre de 2022, de https://www.ejie.euskadi.eus/infraestructuras//webejie00-contserv/es/ |
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| D017437 |
| Skin and Connective Tissue Diseases |