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

NCT ID: NCT07301671

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-17

Study Completion Date

2025-10-29

Brief Summary

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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

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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

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Digital Shoulder Rehabilitation

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gobierno de Navarra

UNKNOWN

Sponsor Role collaborator

Universidad Pública de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorena Y Castaño, PhD student

Role: PRINCIPAL_INVESTIGATOR

Universidad Publica de Navarra

Igor Setuain, Phd

Role: STUDY_DIRECTOR

TDN Clinica

Jose A Sanz D, PhD

Role: STUDY_DIRECTOR

Universidad Publica de Navarra

Iban Latasa Z., PhD

Role: STUDY_DIRECTOR

IED Electronics

Locations

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Lorena Castaño de Egues

Noáin, Navarre, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 28173784 (View on PubMed)

Other Identifiers

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0011-1408-2022-000012

Identifier Type: OTHER

Identifier Source: secondary_id

1479272TES

Identifier Type: -

Identifier Source: org_study_id