Breast Cancer FemaleNCT06699875
Conventional Therapy vs. Telerehabilitation With TRAK in Patients Undergoing Axillary Lymph Node Removal
A study testing Trak exercise prescription protocol at home and Conventional rehabilitation plan at home in people with Breast Cancer Female, run by Trak Health Solutions S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Trak exercise prescription protocol at home and Conventional rehabilitation plan at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 16 May 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Donostia University Hospital (HU Donostia, OSI Donostialdea)
Donostia / San Sebastian, Basque Country, 20018
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Trak exercise prescription protocol at home, Conventional rehabilitation plan at home
- Keywords
- breast cancer, telerehabilitation, telemedicine, digital health, exercise program, physiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trak exercise prescription protocol at homeOther
Online exercise protocol using the TRAK software. The patient will undergo 4 weeks of an exercise prescription protocol based on shoulder mobility exercises.
Conventional rehabilitation plan at homeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TRAK software intervention group | Experimental | The patients will undergo 4 weeks of treatment using the TRAK platform for shoulder mobility-oriented exercises. Receives: 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. Receives: Other: Conventional rehabilitation plan at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder abduction mobility
Active shoulder abduction the patient is able to do actively measurded with a goniometer
Measured: 2-3 days; 15 days; 4-5 and 14 weeks after the surgery
Secondary outcomes (2)
Shoulder flexion mobility
Active shoulder abduction the patient is able to do actively measurded with a goniometer
Measured: 2-3 days; 15 days; 4-5 and 14 weeks after the surgery
TRAK designed tool satisfaction questionnaire
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start16 May 2023
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trak Health Solutions S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogipuzkoa Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Mikel Zabaleta Sistiaga, Principal investigator, Donostia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699875
- Sponsor's protocol ID
- TRAK-LINFA
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35500200Mahmoud 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.
PubMed 34287208Lim JH, Lee HS, Song CS. Home-based rehabilitation programs on postural balance, walking, and quality of life in patients with stroke: A single-blind, randomized controlled trial. Medicine (Baltimore). 2021 Sep 3;100(35):e27154. doi: 10.1097/MD.0000000000027154.
PubMed 34477171Chae SH, Kim Y, Lee KS, Park HS. Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study. JMIR Mhealth Uhealth. 2020 Jul 9;8(7):e17216. doi: 10.2196/17216.
PubMed 32480361Burns DM, Leung N, Hardisty M, Whyne CM, Henry P, McLachlin S. Shoulder physiotherapy exercise recognition: machine learning the inertial signals from a smartwatch. Physiol Meas. 2018 Jul 23;39(7):075007. doi: 10.1088/1361-6579/aacfd9.
PubMed 29952759Hosseiniravandi M, Kahlaee AH, Karim H, Ghamkhar L, Safdari R. Home-based telerehabilitation software systems for remote supervising: a systematic review. Int J Technol Assess Health Care. 2020 Apr;36(2):113-125. doi: 10.1017/S0266462320000021. Epub 2020 Mar 10.
PubMed 32151291Suso-Marti L, La Touche R, Herranz-Gomez A, Angulo-Diaz-Parreno S, Paris-Alemany A, Cuenca-Martinez F. Effectiveness of Telerehabilitation in Physical Therapist Practice: An Umbrella and Mapping Review With Meta-Meta-Analysis. Phys Ther. 2021 May 4;101(5):pzab075. doi: 10.1093/ptj/pzab075.
PubMed 33611598Sotirova MB, McCaughan EM, Ramsey L, Flannagan C, Kerr DP, O'Connor SR, Blackburn NE, Wilson IM. Acceptability of online exercise-based interventions after breast cancer surgery: systematic review and narrative synthesis. J Cancer Surviv. 2021 Apr;15(2):281-310. doi: 10.1007/s11764-020-00931-6. Epub 2020 Sep 15.
PubMed 32930924Anton D, Berges I, Bermudez J, Goni A, Illarramendi A. A Telerehabilitation System for the Selection, Evaluation and Remote Management of Therapies. Sensors (Basel). 2018 May 8;18(5):1459. doi: 10.3390/s18051459.
PubMed 29738442Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.
PubMed 31233135Amin J, Ahmad B, Amin S, Siddiqui AA, Alam MK. Rehabilitation Professional and Patient Satisfaction with Telerehabilitation of Musculoskeletal Disorders: A Systematic Review. Biomed Res Int. 2022 Aug 2;2022:7366063. doi: 10.1155/2022/7366063. eCollection 2022.
PubMed 35958819Moral-Munoz JA, Zhang W, Cobo MJ, Herrera-Viedma E, Kaber DB. Smartphone-based systems for physical rehabilitation applications: A systematic review. Assist Technol. 2021 Jul 4;33(4):223-236. doi: 10.1080/10400435.2019.1611676. Epub 2019 May 21.
PubMed 31112461Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.
PubMed 33561280Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.
PubMed 30946436Shenoy P, Shenoy P. Identifying the Challenges and Cost-effectiveness of Telerehabilitation: A Narrative Review. Journal of Clinical and Diagnostic Research. 2018 12;12:1-4
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06699875
- Acronym / sponsor ID
- TRAK-LINFA
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer, telerehabilitation, telemedicine, digital health, exercise program, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Trak Health Solutions S.L.Industry (pharma, biotech, devices)
- Collaborators
- Biogipuzkoa Health Research Institute
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TRAK software intervention group | Experimental | Other: Trak exercise prescription protocol at homeThe patients will undergo 4 weeks of treatment using the TRAK platform for shoulder mobility-oriented exercises. |
| Paper sheet group | Active comparator | Other: Conventional rehabilitation plan at homeThe patients will undergo 4 weeks of treatment using an exercise paper sheet routine to improve shoulder mobility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trak exercise prescription protocol at homeOnline exercise protocol using the TRAK software. The patient will undergo 4 weeks of an exercise prescription protocol based on shoulder mobility exercises. | Other | TRAK software intervention group |
| Conventional rehabilitation plan at homeTreatment 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. | Other | Paper sheet group |
Primary outcome
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 secondary outcomes
Shoulder flexion mobility
Time frame: 2-3 days; 15 days; 4-5 and 14 weeks after the surgery
TRAK designed tool satisfaction questionnaire
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 35500200Singleton 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.
- Background: PubMed 34287208Mahmoud 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.
- Background: PubMed 34477171Lim JH, Lee HS, Song CS. Home-based rehabilitation programs on postural balance, walking, and quality of life in patients with stroke: A single-blind, randomized controlled trial. Medicine (Baltimore). 2021 Sep 3;100(35):e27154. doi: 10.1097/MD.0000000000027154.
- Background: PubMed 32480361Chae SH, Kim Y, Lee KS, Park HS. Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study. JMIR Mhealth Uhealth. 2020 Jul 9;8(7):e17216. doi: 10.2196/17216.
- Background: PubMed 29952759Burns DM, Leung N, Hardisty M, Whyne CM, Henry P, McLachlin S. Shoulder physiotherapy exercise recognition: machine learning the inertial signals from a smartwatch. Physiol Meas. 2018 Jul 23;39(7):075007. doi: 10.1088/1361-6579/aacfd9.
- Background: PubMed 32151291Hosseiniravandi M, Kahlaee AH, Karim H, Ghamkhar L, Safdari R. Home-based telerehabilitation software systems for remote supervising: a systematic review. Int J Technol Assess Health Care. 2020 Apr;36(2):113-125. doi: 10.1017/S0266462320000021. Epub 2020 Mar 10.
- Background: PubMed 33611598Suso-Marti L, La Touche R, Herranz-Gomez A, Angulo-Diaz-Parreno S, Paris-Alemany A, Cuenca-Martinez F. Effectiveness of Telerehabilitation in Physical Therapist Practice: An Umbrella and Mapping Review With Meta-Meta-Analysis. Phys Ther. 2021 May 4;101(5):pzab075. doi: 10.1093/ptj/pzab075.
- Background: PubMed 32930924Sotirova MB, McCaughan EM, Ramsey L, Flannagan C, Kerr DP, O'Connor SR, Blackburn NE, Wilson IM. Acceptability of online exercise-based interventions after breast cancer surgery: systematic review and narrative synthesis. J Cancer Surviv. 2021 Apr;15(2):281-310. doi: 10.1007/s11764-020-00931-6. Epub 2020 Sep 15.
- Background: PubMed 29738442Anton D, Berges I, Bermudez J, Goni A, Illarramendi A. A Telerehabilitation System for the Selection, Evaluation and Remote Management of Therapies. Sensors (Basel). 2018 May 8;18(5):1459. doi: 10.3390/s18051459.
- Background: PubMed 31233135Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.
- Background: PubMed 35958819Amin J, Ahmad B, Amin S, Siddiqui AA, Alam MK. Rehabilitation Professional and Patient Satisfaction with Telerehabilitation of Musculoskeletal Disorders: A Systematic Review. Biomed Res Int. 2022 Aug 2;2022:7366063. doi: 10.1155/2022/7366063. eCollection 2022.
- Background: PubMed 31112461Moral-Munoz JA, Zhang W, Cobo MJ, Herrera-Viedma E, Kaber DB. Smartphone-based systems for physical rehabilitation applications: A systematic review. Assist Technol. 2021 Jul 4;33(4):223-236. doi: 10.1080/10400435.2019.1611676. Epub 2019 May 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikel Zabaleta Sistiaga principal investigator
Donostia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trak exercise prescription protocol at home and Conventional rehabilitation plan at home in people with Breast Cancer Female, run by Trak Health Solutions S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder abduction mobility (time frame: 2-3 days; 15 days; 4-5 and 14 weeks after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06699875, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.