Shoulder PainTRAK-RURALNCT06796309
Assessment of Rural Health Care: Implementing TRAK Digital Tool for Quality and Accessible Services
A study testing Trak Telerehabilitation Platform and Conventional Rehabilitation Program in people with Shoulder Pain, run by Trak Health Solutions S.L. at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Trak Telerehabilitation Platform and Conventional Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They carry out their activity in a rural environment.
- That they know how to use the tool.
- That they have a device with which to use the tool.
- That they have an e-mail address.
- That they have an Internet connection.
- That they have signed the informed consent form.
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- Seniors.
- Patients with omalgia of more than 6 months of evolution.
- Who have a device with which to use the tool.
- Who have a device with which to use the tool.
- Who have an Internet connection.
- Who have an e-mail address.
- Who have signed the informed consent form.
Who cannot join
- N/A
- Patients with cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario del Sureste
Madrid, 28500
ANA VADILLO CORTÁZAR, +34 918394527, ana.vadilloc@salud.madrid.org
ANA VADILLO CORTÁZAR
About this study
Official title: Assessment of Rural Health Care: Introduction of the TRAK Digital Tool for Quality and Accessible Medical Care
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).
Read the detailed description
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.
- Conditions
- Shoulder Pain
- Being tested
- Trak Telerehabilitation Platform, Conventional Rehabilitation Program
- Keywords
- shoulder pain, telerehabilitation, telemedicine, exercise program, physiotherapy, healthcare personnel
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trak Telerehabilitation PlatformOther
The exercise protocol designed is carried out through TRAK, the digital rehabilitation tool.
Conventional Rehabilitation ProgramOther
Exercise protocol with the methodology of conventional clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Trak Telerehabilitation Platform |
| Control Group (Population 2) | Active comparator | Patients in the control group will undergo the same rehabilitation period (8 weeks) but following standard clinical practice. Receives: Other: Conventional Rehabilitation Program |
| 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. Receives: Other: Trak Telerehabilitation Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Last visit, week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: week 1 and 8
Number of patients using the platform
The total number of patients who are using the TRAK platform.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start7 Feb 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trak Health Solutions S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Gregorio Marañón
- Responsible party
- Sponsor
- Investigators
- ANA VADILLO CORTÁZAR, Principal investigator, Hospital Universitario del Sureste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796309
- Sponsor's protocol ID
- TRAK-RURAL
- Acronym
- TRAK-RURAL
- Status last verified
- Apr 2025
- First submitted
- 7 Jan 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Rural Health Care: Introduction of the TRAK Digital Tool for Quality and Accessible Medical Care
- ClinicalTrials.gov ID
- NCT06796309
- Acronym / sponsor ID
- TRAK-RURAL / TRAK-RURAL
- Conditions
- Shoulder Pain
- Keywords
- shoulder pain, telerehabilitation, telemedicine, exercise program, physiotherapy, healthcare personnel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Trak Health Solutions S.L.Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Gregorio Marañón
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TRAK treatment group (Population 2) | Experimental | Other: Trak Telerehabilitation PlatformPatients 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. |
| Control Group (Population 2) | Active comparator | Other: Conventional Rehabilitation ProgramPatients in the control group will undergo the same rehabilitation period (8 weeks) but following standard clinical practice. |
| Healthcare professional Group (Population 1) | Other | Other: Trak Telerehabilitation PlatformHealthcare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- They carry out their activity in a rural environment.
- That they know how to use the tool.
- That they have a device with which to use the tool.
- That they have an e-mail address.
- That they have an Internet connection.
Key exclusion criteria (2 listed)
- N/A
- Patients with cognitive impairment.
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 Telerehabilitation PlatformThe exercise protocol designed is carried out through TRAK, the digital rehabilitation tool. | Other | Healthcare professional Group (Population 1), TRAK treatment group (Population 2) |
| Conventional Rehabilitation ProgramExercise protocol with the methodology of conventional clinical practice. | Other | Control Group (Population 2) |
Primary outcome
Telemedicine Usability Questionnaire (TUQ).
Time frame: Last visit, week 8
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.
Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ).
Time frame: Last visit, week 8
Scale designed to evaluate the satisfaction and usefulness perceived by telemedicine users from 17 to 85 points.
3 secondary outcomes
European quality of life 5 dimension questionnaire (EuroQol-5D)
Time frame: week 1 and 8
Focus on Shoulder Pain and Disability Index (SPADI-Br).
Time frame: week 1 and 8
Number of patients using the platform
Time frame: week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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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.
ANA VADILLO CORTÁZAR principal investigator
Hospital Universitario del Sureste
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 Telerehabilitation Platform and Conventional Rehabilitation Program in people with Shoulder Pain, 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 13 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JUAN F DUARTE MENDOZA (+34 677 33 4869, juanfernando@trak.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telemedicine Usability Questionnaire (TUQ). (time frame: Last visit, week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.