Prospective Cohort of Digital Shoulder Rehabilitation Using the REHABI System in Routine Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Digital Shoulder Rehabilitation

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 Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Spain
  • Navarre
    • Noáin, Navarre, Spain, 31110
      • Lorena Castaño de Egues

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 18-71 years of age, acute non-traumatic shoulder pain/dysfunction, and access to a smartphone to view the exercises.

Exclusion Criteria:

• Acute fractures or dislocations, arthritis/arthrosis, osteosarcoma, osteomyelitis, and recent shoulder surgeries.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and discharge (approximately 1-6 months after baseline, depending on clinical evolution)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline and discharge (approximately 1-6 months)

Collaborators and Investigators

• Sponsor: Universidad Pública de Navarra
• Collaborators: Gobierno de Navarra
• Investigators: Principal Investigator: Lorena Y Castaño, PhD student, Universidad Pública de Navarra; Study Director: Igor Setuain, PHD, TDN Clinica; Study Director: Jose A Sanz D, PhD, Universidad Pública de Navarra; Study Director: Iban Latasa Z., PhD, IED Electronics

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Actual): October 29, 2025
• Study Completion (Actual): October 29, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: clinical effectiveness; Shoulder rehabilitation; functional assessment; digital physiotherapy; responsiveness (SRM); Clinical automation
• Other Study ID Numbers: 1479272TES; 0011-1408-2022-000012 (Other Identifier: Beca de Doctorado Industrial 2022 del Gobierno de Navarra)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No