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

NCT07301671 | Completed

• 2 other identifiers: 1479272TES0011-1408-2022-000012
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Digital Shoulder Rehabilitation

Keywords

Shoulder rehabilitation; digital physiotherapy; functional assessment; responsiveness (SRM); clinical effectiveness; Clinical automation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in selected functional tests from the optimized core battery

  Baseline and discharge (ranging from 1 month to 6 month after baseline)

• Number of rehabilitation sessions until discharge

  From baseline to discharge (approximately 1-6 months)

• Days from baseline to clinical discharge

  Baseline to discharge (ranging from 1 to 6 months)

• Change in shoulder pain intensity (Numeric Rating Scale, 0-10)

  Baseline and discharge (approximately 1-6 months)

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• Gobierno de Navarra: collaborator

Study Sites (1)

Lorena Castaño de Egues

Noáin, Navarre, 31110, Spain

Location

Related Publications (1)

• 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.

  PMID: 28173784 RESULT

Study Officials

• Lorena Y Castaño, PhD student

  Universidad Publica de Navarra

  PRINCIPAL INVESTIGATOR

• Igor Setuain, Phd

  TDN Clinica

  STUDY DIRECTOR

• Jose A Sanz D, PhD

  Universidad Publica de Navarra

  STUDY DIRECTOR

• Iban Latasa Z., PhD

  IED Electronics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 24, 2025
• Study Start: March 17, 2025
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)