The clinical investigation is designed as a controlled, two-arm, intra-patient, non-randomized interventional study aimed at assessing the capabilities of the AuReha system in detecting upper limb movement precision in patients with unilateral proprioceptive impairment. The comparison will be conducted within the same subject, between the healthy limb and the impaired limb, through the execution of proprioceptive exercises in an open kinetic chain. The biomechanical parameters collected will include movement precision, trunk stability, compensatory movements, and joint range of motion. In addition to the quantitative analysis, qualitative data will also be collected regarding usability, wearability, and user experience of the system through questionnaires administered to both patients and healthcare professionals.
The study will be conducted at the Shoulder Team Outpatient Clinic in Forlì, enrolling approximately 52 patients.
patients with a healthy contralateral limb
patients affected by orthopedic shoulder conditions such as posterior instability, anterior instability, anterior Latarjet instability, adhesive capsulitis, or prostheses
age ≥18 years
patients who consent to participate in the study by signing the informed consent form
Pregnant and/or breastfeeding women (verified through self-declaration)
Epilepsy
Allergy or hypersensitivity to materials used in the medical device, specifically: polypropylene and lycra (fabric), nylon (integrated zipper), viscose and elastane (zipper integration fabric)
Chronic headache under treatment
Single group
Upper limb rehabilitation wearable device
DeviceThe intervention consists in using the AuReha system to perform a series of upper limb rehabilitation exercises. No therapeutic or diagnostic interventions will be administered, as this is a non-invasive study focused on system validation and user feedback.
Evaluation of the intra-subject difference in movement accuracy during a target-reaching exercise proposed by the AuReha system, between the healthy limb and the limb affected by motor deficit
Unit of measurement: Percentage (%) - Movement accuracy, expressed as a percentage, measures how precisely the patient performs the prescribed movements, by assessing the deviation of the executed movement from the ideal movement to be performed.
Characterization of AuReha in measuring trunk stability
Trunk stability is a parameter calculated by the AuReha Web Platform that assesses the inclination of the trunk across the three reference planes (frontal, sagittal, and transverse) during exercise execution. Trunk stability is an essential parameter to ensure the correct performance of upper limb movements and to prevent harmful compensations that could negatively impact recovery. Unit of Measure: Percentage (%)
Characterization of AuReha in measuring limb compensation
Limb compensation is a parameter calculated by the AuReha Web Platform that monitors any incorrect compensatory movements performed by the limbs during exercises. For example, it can detect shoulder elevation during elbow flexion, or elbow flexion during shoulder movements. This parameter is crucial for identifying and correcting dysfunctional movement patterns that could compromise the rehabilitation process. Unit of Measure: Percentage (%)
Characterization of AuReha in measuring the distance to a specified target
This parameter evaluates the final distance from the target to be reached. Unit of Measure: Percentage (%)
Characterization of AuReha in measuring the duration of the movement
This parameter calculates the duration of movement execution. Unit of Measure: seconds (s)
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