Digital Shoulder RehabilitationNCT07301671
Prospective Cohort of Digital Shoulder Rehabilitation Using the REHABI System in Routine Clinical Practice
An observational study of Digital Shoulder Rehabilitation, run by Universidad Pública de Navarra at 1 site in Spain.
Trial summary
This is a prospective longitudinal observational cohort study of patients with shoulder disorders undergoing a standardized rehabilitation program supported by the REHABI digital automated model in a private physiotherapy clinic. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Digital Shoulder Rehabilitation
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- 17 Mar 2025to 29 Oct 2025
- Phase
- Observational
- 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 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with musculoskeletal shoulder pain treated in a private sports physiotherapy clinic in Pamplona, Spain, who are referred or self-referred for conservative management, consecutively enrolled in the REHABI digital rehabilitation program, and who have access to and basic skills to use a smartphone.
Who may be able to join
- 18-71 years of age, acute non-traumatic shoulder pain/dysfunction, and access to a smartphone to view the exercises.
Who cannot join
- Acute fractures or dislocations, arthritis/arthrosis, osteosarcoma, osteomyelitis, and recent shoulder surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Longitudinal Observational Cohort Study of a Digital Automated Rehabilitation Model for Shoulder Disorders (REHABI) in a Private Physiotherapy Clinic
This is a prospective longitudinal observational cohort study of patients with shoulder disorders undergoing a standardized rehabilitation program supported by the REHABI digital automated model in a private physiotherapy clinic. The study aims to describe clinical outcomes in routine practice and to optimize a 24-test functional assessment battery based on deficit prevalence, magnitude, and responsiveness.
Read the detailed description
This is a prospective longitudinal observational cohort study of 129 adult patients (≥18 and ≤71 years) with acute non-traumatic shoulder pain and/or dysfunction treated in a private sports physiotherapy clinic in Pamplona, Spain. All patients undergo a standardized rehabilitation program supported by the REHABI automated digital model, which links quantified deficits obtained from a 24-test functional assessment battery to specific exercise prescriptions and progression rules. The study aims to describe clinical outcomes in routine practice (global clinical deficit score, shoulder pain intensity, number of treatment sessions, and days to discharge) and to optimize the initial 24-test battery based on deficit prevalence, magnitude, and responsiveness to change between baseline and discharge.
The main objectives are: (1) to evaluate the clinical effectiveness and feasibility of the REHABI model in routine clinical practice; and (2) to reduce the initial 24-test assessment battery to a smaller core set of tests using mixed criteria based on prevalence, magnitude of deficit, and responsiveness to change.
- Conditions
- Digital Shoulder Rehabilitation
- Keywords
- Shoulder rehabilitation, digital physiotherapy, functional assessment, responsiveness (SRM), clinical effectiveness, Clinical automation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global clinical deficit score from baseline to discharge
Global clinical score summarizing the number and magnitude of positive findings in the functional test battery. Higher scores indicate greater functional deficit. Change is calculated as discharge score minus baseline score.
Measured: Baseline and discharge (approximately 1-6 months after baseline, depending on clinical evolution)
Secondary outcomes (4)
Change in selected functional tests from the optimized core battery
Change in performance on selected shoulder functional tests (e.g., Yocum, Speed, Jobe, external rotation at 90° abduction, etc.) identified as part of the optimized core test battery.
Measured: Baseline and discharge (ranging from 1 month to 6 month after baseline)
Number of rehabilitation sessions until discharge
Total number of physiotherapy sessions attended from baseline to discharge within the REHABI program.
Measured: From baseline to discharge (approximately 1-6 months)
Days from baseline to clinical discharge
Number of days between the first assessment and the discharge visit recorded in the REHABI system.
Measured: Baseline to discharge (ranging from 1 to 6 months)
Change in shoulder pain intensity (Numeric Rating Scale, 0-10)
Shoulder pain intensity during movement, measured using an 11-point Numeric Rating Scale (EVA 0-10). Change is calculated as discharge score minus baseline score.
Measured: Baseline and discharge (approximately 1-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start17 Mar 2025
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Digital Shoulder RehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Navarra
- Responsible party
- Sponsor
- Investigators
- Lorena Y Castaño, PhD student, Principal investigator, Universidad Publica de NavarraIgor Setuain, Phd, Study director, TDN ClinicaJose A Sanz D, PhD, Study director, Universidad Publica de NavarraIban Latasa Z., PhD, Study director, IED Electronics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301671
- Sponsor's protocol ID
- 1479272TES
- Other IDs
- 0011-1408-2022-000012
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At present, there is no plan to share individual participant data (IPD). This is a single-center study with a relatively small sample and detailed clinical assessments, which may increase the risk of re-identification, and the original informed consent did not explicitly cover broad IPD sharing. De-identified summary results will be available in the published manuscript, and additional aggregated information may be considered upon reasonable request.
Publications
Setuain I, Gonzalez-Izal M, Paularena A, Luque JL, Andersen LL, Izquierdo M. A protocol for a new methodological model for work-related shoulder complex injuries: From diagnosis to rehabilitation. BMC Musculoskelet Disord. 2017 Feb 7;18(1):70. doi: 10.1186/s12891-017-1435-2.
PubMed 28173784Castano L, Sanz J, Latasa I, Setuain I. Implementation, feasibility and optimization of a web- and mobile-supported semi-automated shoulder rehabilitation system (WMSSR): a prospective consecutive interventional cohort study. BMC Musculoskelet Disord. 2026 Jul 28;27(1):904. doi: 10.1186/s12891-026-10259-4.
PubMed 42919177
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Observational Cohort Study of a Digital Automated Rehabilitation Model for Shoulder Disorders (REHABI) in a Private Physiotherapy Clinic
- ClinicalTrials.gov ID
- NCT07301671
- Acronym / sponsor ID
- 1479272TES
- Conditions
- Digital Shoulder Rehabilitation
- Keywords
- Shoulder rehabilitation, digital physiotherapy, functional assessment, responsiveness (SRM), clinical effectiveness, Clinical automation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Collaborators
- Government of Navarra
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 24 Dec 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 is a prospective longitudinal observational cohort study of patients with shoulder disorders undergoing a standardized rehabilitation program supported by the REHABI digital automated model in a private physiotherapy clinic. The study aims to describe clinical outcomes in routine practice and to optimize a 24-test functional assessment battery based on deficit prevalence, magnitude, and responsiveness.
Detailed description
This is a prospective longitudinal observational cohort study of 129 adult patients (≥18 and ≤71 years) with acute non-traumatic shoulder pain and/or dysfunction treated in a private sports physiotherapy clinic in Pamplona, Spain. All patients undergo a standardized rehabilitation program supported by the REHABI automated digital model, which links quantified deficits obtained from a 24-test functional assessment battery to specific exercise prescriptions and progression rules. The study aims to describe clinical outcomes in routine practice (global clinical deficit score, shoulder pain intensity, number of treatment sessions, and days to discharge) and to optimize the initial 24-test battery based on deficit prevalence, magnitude, and responsiveness to change between baseline and discharge.
The main objectives are: (1) to evaluate the clinical effectiveness and feasibility of the REHABI model in routine clinical practice; and (2) to reduce the initial 24-test assessment battery to a smaller core set of tests using mixed criteria based on prevalence, magnitude of deficit, and responsiveness to change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with musculoskeletal shoulder pain treated in a private sports physiotherapy clinic in Pamplona, Spain, who are referred or self-referred for conservative management, consecutively enrolled in the REHABI digital rehabilitation program, and who have access to and basic skills to use a smartphone.
Key inclusion criteria (1 listed)
- 18-71 years of age, acute non-traumatic shoulder pain/dysfunction, and access to a smartphone to view the exercises.
Key exclusion criteria (1 listed)
- Acute fractures or dislocations, arthritis/arthrosis, osteosarcoma, osteomyelitis, and recent shoulder surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in global clinical deficit score from baseline to discharge
Time frame: Baseline and discharge (approximately 1-6 months after baseline, depending on clinical evolution)
Global clinical score summarizing the number and magnitude of positive findings in the functional test battery. Higher scores indicate greater functional deficit. Change is calculated as discharge score minus baseline score.
4 secondary outcomes
Change in selected functional tests from the optimized core battery
Time frame: Baseline and discharge (ranging from 1 month to 6 month after baseline)
Number of rehabilitation sessions until discharge
Time frame: From baseline to discharge (approximately 1-6 months)
Days from baseline to clinical discharge
Time frame: Baseline to discharge (ranging from 1 to 6 months)
Change in shoulder pain intensity (Numeric Rating Scale, 0-10)
Time frame: Baseline and discharge (approximately 1-6 months)
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 24 Dec 2025.
- Results publication: PubMed 28173784Setuain I, Gonzalez-Izal M, Paularena A, Luque JL, Andersen LL, Izquierdo M. A protocol for a new methodological model for work-related shoulder complex injuries: From diagnosis to rehabilitation. BMC Musculoskelet Disord. 2017 Feb 7;18(1):70. doi: 10.1186/s12891-017-1435-2.
- Derived from this study: PubMed 42919177Castano L, Sanz J, Latasa I, Setuain I. Implementation, feasibility and optimization of a web- and mobile-supported semi-automated shoulder rehabilitation system (WMSSR): a prospective consecutive interventional cohort study. BMC Musculoskelet Disord. 2026 Jul 28;27(1):904. doi: 10.1186/s12891-026-10259-4.
- Individual participant dataSharing planned: No. At present, there is no plan to share individual participant data (IPD). This is a single-center study with a relatively small sample and detailed clinical assessments, which may increase the risk of re-identification, and the original informed consent did not explicitly cover broad IPD sharing. De-identified summary results will be available in the published manuscript, and additional aggregated information may be considered upon reasonable request.
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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.
Lorena Y Castaño, PhD student principal investigator
Universidad Publica de Navarra
Igor Setuain, Phd study director
TDN Clinica
Jose A Sanz D, PhD study director
Universidad Publica de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digital Shoulder Rehabilitation, run by Universidad Pública de Navarra 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 1 inclusion and 1 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 24 Dec 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?
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?
Change in global clinical deficit score from baseline to discharge (time frame: Baseline and discharge (approximately 1-6 months after baseline, depending on clinical evolution)). 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 NCT07301671, which also lists 2 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 24 Dec 2025.