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| Name | Class |
|---|---|
| University Hospital Gregorio Marañón | OTHER |
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This clinical trial aims to analyze the usability and degree of satisfaction of two populations, healthcare personnel (Population 1) in rural areas and their patients (Population 2), with the TRAK tele-rehabilitation tool.
Participants will undergo telerehabilitation treatment through the TRAK platform for eight weeks (treatment group) or follow an at home exercise protocol (control group).
The recruitment process for this study is aimed at patients with shoulder pain (population 2) and healthcare personnel (population 1).
After the initial screening, individuals who meet the study's predefined inclusion criteria will be invited to participate. Before enrollment, written informed consent will be obtained from all participants, ensuring ethical compliance and respect for individual autonomy.
The healthcare personnel (population 1) will use Trak during the entire study period, from the time of entry into the study to the time of exit.
The study cohort will consist of patients randomly assigned to the experimental group (EG) and the control group (CG) on the first in person visit for the population 2 (patients). Regardless of group assignment, all patients will undergo baseline health assessments, ensuring that their individual needs are met. The satisfaction questionnaire will be deferred until post-intervention for both groups.
Participants in both groups will begin by filling out the Quality of Life Scale (EuroQol 5). and Shoulder Functional Assessment Scale (SPADI-Br) on the first visit.
In the case of the treatment group (EG), the participants will use the platform following the treatment prescribed by their health professionals for a period of 2 months. in the case of the control group (CG), the patients will follow the usual clinical practice treatment (they will receive the exercise protocol in paper format).
At the end of the treatment period, a final face-to-face visit will be made.
Patients (population 2) will undergo 8 weeks of treatment through the TRAK tool (https://www.trakphysio.com/es/) in the EG. Patients from the EG will carry out the treatment through the platform at home, and those from the CG will follow an on paper exercise protocol based on the usual (in-person) clinical practice methodology. Both groups will perform exercises in these rehabilitation sessions to improve shoulder mobility.
The results will be evaluated using different métrics, such as Telemedicine Usability Questionnaire (TUQ) and Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ), wich are the main ones, number of patients using the platform, the EuroQol-5D and the shoulder functional evaluation scale (SPADI-Br). These scales will be completed on paper at the beginning and end of the study for both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAK treatment group (Population 2) | Experimental | Patients will use Trak platform for 8 weeks (2 months) for their exercise program. The use of the tool involves performing the corresponding therapeutic exercise program through it. The frequency of the exercises will be determined by the healthcare professional responsible for the patient, based on the needs identified during the assessment, ranging from 3 to 7 days per week. |
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| Control Group (Population 2) | Active Comparator | Patients in the control group will undergo the same rehabilitation period (8 weeks) but following standard clinical practice. |
|
| Healthcare professional Group (Population 1) | Other | Healthcare professionals who will have access to the tool to prescribe exercise sessions for their patients, monitor their progress, adapt and modify the exercise program, communicate with patients to address their questions, and track their progress over time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trak Telerehabilitation Platform | Other | The exercise protocol designed is carried out through TRAK, the digital rehabilitation tool. |
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| Measure | Description | Time Frame |
|---|---|---|
| Telemedicine Usability Questionnaire (TUQ). | The TUQ is a questionnaire specifically designed to measure (from 17 to 109 points) the usability of telemedicine systems from the perspective of healthcare personnel. | Last visit, week 8 |
| Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ). | Scale designed to evaluate the satisfaction and usefulness perceived by telemedicine users from 17 to 85 points. | Last visit, week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| European quality of life 5 dimension questionnaire (EuroQol-5D) | Generic and standardized questionnaire developed to describe and assess health-related quality of life. This questionnaire has an EVA scale from 0 to 100 and 5 questions that gives a 5 digit patient profile (From 11111 if the patients does not have problems on any item to 33333 if the patients have severe problems). The items valued are personal care, daily activities, mobility, pain and anxiety/depression. |
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Inclusion Criteria population 1:
Exclusion Criteria population 1:
Inclusion Criteria population 2:
Exclusion Criteria population 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JUAN F DUARTE MENDOZA | Contact | +34 677 33 4869 | juanfernando@trak.es |
| Name | Affiliation | Role |
|---|---|---|
| ANA VADILLO CORTÁZAR | Hospital Universitario del Sureste | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario del Sureste | Recruiting | Madrid | 28500 | Spain |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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Prospective experimental study with 95 participants (15 from Population 1; 80 from Population 2) included based on compliance with inclusion and exclusion criteria.
Population 1:
Fifteen healthcare professionals will be recruited.
The intervention targets patients with musculoskeletal pathologies using randomized allocation into two groups: a treatment group utilizing Trak and a control group following conventional rehabilitation methods.
Population 2:
Eighty patients will be randomly assigned to the experimental or control group in a 1:1 ratio.
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Randomization is achieved through permuted block randomization with a 1:1 allocation ratio, ensuring balance. The intervention includes remote rehabilitation exercises supported by healthcare professionals, with outcomes assessed independently for both populations (healthcare staff and patients).
| Conventional Rehabilitation Program | Other | Exercise protocol with the methodology of conventional clinical practice. |
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| week 1 and 8 |
| Focus on Shoulder Pain and Disability Index (SPADI-Br). | The SPADI-Br was designed to evaluate the degree of shoulder pain and discomfort in performing activities of daily living from 0 to 130 points. | week 1 and 8 |
| Number of patients using the platform | The total number of patients who are using the TRAK platform. | week 8 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |