Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions

This prospective, observational diagnostic validation study aims to evaluate the accuracy and operational feasibility of SMARTDIAGO, a digital platform that uses artificial intelligence and functional video analysis to remotely assess patients with musculoskeletal conditions and functional frailty.

Approximately 350 outpatients referred from primary care services will undergo a remote functional assessment using SMARTDIAGO, followed by an in-person assessment at the hospital and a clinical evaluation by a specialist.

Functional assessments will include the 30-second Sit-to-Stand test, joint range of motion measurements, and questionnaires addressing pain, functional status, and relevant medical history.

Clinicians performing in-person assessments will be blinded to SMARTDIAGO results to minimize assessment bias.

Diagnostic performance will be evaluated using sensitivity, specificity, receiver operating characteristic curves, area under the curve, calibration, and agreement with clinical reference assessments. Operational feasibility will be assessed through execution time, repeated attempts, and user satisfaction.

The study does not involve therapeutic interventions, experimental medications, or changes to usual clinical care.

• SMARTDIAGO Remote Functional Assessment (Diagnostic test): SMARTDIAGO is an artificial intelligence-based digital platform designed for remote functional assessment using video-based movement analysis. Participants will perform standardized functional tests, including the 30-second Sit-to-Stand test and joint range of motion assessments, using a smartphone or computer camera. The system will analyze movement and functional performance. Results will be compared with standardized in-person clinical assessments performed by blinded healthcare professionals. SMARTDIAGO will not administer treatment or modify usual clinical care.

Primary outcomes

• Diagnostic Accuracy of SMARTDIAGO (AUC-ROC) [From enrollment to the end of assessment at 5 days]: Area under the receiver operating characteristic curve for identifying clinically significant functional impairment or appropriate specialist referral, compared with the standardized clinical reference assessment.

Secondary outcomes

• Sensitivity and Specificity [From enrollment to the end of assessment at 5 days]: Sensitivity and specificity of SMARTDIAGO for identifying clinically significant functional impairment or referral appropriateness.
• Agreement Between SMARTDIAGO and In-Person Assessment [From enrollment to the end of assessment at 5 days]: Agreement between remote functional measurements and standardized in-person clinical assessments.
• Functional Performance [From enrollment to the end of assessment at 5 days]: Number of repetitions completed during the 30-second Sit-to-Stand test.
• Joint Range of Motion [From enrollment to the end of assessment at 5 days]: Joint range of motion assessed in the knee, hip, shoulder, and spine, as applicable.
• Operational Feasibility [From enrollment to the end of assessment at 5 days]: Time required to complete the remote assessment and number of attempts needed.
• User Satisfaction [From enrollment to the end of assessment at 5 days]: Participant-reported ease of use and satisfaction with SMARTDIAGO.

Sex: All, ages: 55 Years to any

Inclusion Criteria:

* Age 55 years or older.
* Referral from primary care for knee, hip, shoulder, or spine disorders, or age 60 years or older with functional frailty.
* Access to a smartphone or computer with a camera.
* Ability to perform simple functional movements, including sitting down and standing up from a chair.

Exclusion Criteria

* Uncontrolled neurological or cardiopulmonary conditions.
* Severe pain at rest (greater than 7/10).
* Recent surgery within the previous three months.
* Mild cognitive impairment with insufficient social support, or moderate-to-severe cognitive impairment.
* Pregnancy.
* Simultaneous participation in another clinical research study.