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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.
The primary goal of this clinical investigation is to support the CE certification process of the AuReha system, a wearable medical device designed for monitoring upper limb movement during rehabilitation.
Specifically, the study aims to assess the movement precision of the upper limb in individuals with unilateral motor impairment. The main objective is to compare, within the same individual, the movement accuracy of the healthy arm versus the impaired arm during a series of rehabilitation exercises guided by the AuReha system.
Secondary objectives include:
These aspects aim to demonstrate the system's ability to support an optimized rehabilitation process. AuReha is designed to help patients perform their prescribed rehabilitation exercises correctly while collecting detailed biomechanical data. This allows clinicians to closely monitor the patient's response to therapy and make data-driven decisions throughout the recovery process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients affected by orthopedic shoulder conditions such as posterior instability, ant | Experimental | The clinical investigation is designed as an interventional, controlled, two-arm intra-patient, non-randomized study aimed at evaluating the capabilities of the AuReha system in detecting the accuracy of upper limb movements in patients with unilateral proprioceptive deficits. The comparison will be conducted within the same subject between the healthy limb and the affected limb, through the performance of proprioceptive exercises in open kinetic chain. No therapeutic or diagnostic interventions will be administered, as this is a non-invasive study focused on system validation and user feedback. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper limb rehabilitation wearable device | Device | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliambulatorio Shoulder Team | Forlì | FC | 47122 | Italy |
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The study has a two-arm intra-patient design, as the comparison will be made within the same subject between the healthy limb and the affected limb.
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| Day 1 |
| 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 (%) | Day 1 |
| 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 (%) | Day 1 |
| Characterization of AuReha in measuring the duration of the movement | This parameter calculates the duration of movement execution. Unit of Measure: seconds (s) | Day 1 |
| Characterization of AuReha in terms of usability for patients with the System Usability Scale (SUS) | Assessment of the usability of AuReha by enrolled patients during the evaluation and execution of proprioceptive exercises. Standardized questionnaires will be used (SUS). The questionnaire assesses usability and overall user experience. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable"). | Day 1 |
| Characterization of AuReha in terms of usability for patients with the User Engagement Scale - Short Form (UES-SF) | Assessment of the usability of AuReha by enrolled patients during the evaluation and execution of proprioceptive exercises. Standardized questionnaires will be used (UES-SF). This questionnaire collects user feedback on the AuReha App and the sensorized shirt, focusing on the engagement. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable"). | Day 1 |
| Characterization of AuReha in terms of usability for patients | Assessment of the usability of AuReha by enrolled patients during the evaluation and execution of proprioceptive exercises. Custom questionnaires have been developed for this purpose and are annexed to the clinical protocol. These questionnaires collect user feedback on the AuReha App and the sensorized shirt, focusing on usability, engagement, clarity of instructions, and garment fit. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable"), and include open-text fields for qualitative insights. | Day 1 |
| Characterization of AuReha in terms of usability for healthcare professionals | Standardized questionnaires will be used, specifically the Healthcare System Usability Scale (HSUS). In addition, custom questionnaires have been developed for this purpose and are annexed to the clinical protocol. These questionnaires collect user feedback on the AuReha App and the sensorized shirt, focusing on usability and clarity of instructions. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable") and include open-text fields for qualitative insights. | Day 1 |
| Correlation between AuReha shirt size (categorical: XS, S, M, L,) and the anthropometric measurements of healthy volunteers (in cm) | Evaluation of AuReha's fit on healthy volunteers, through the assessment of the correlation between the selected shirt size (categorical: XS, S, M, L) and continuous anthropometric variables, including body circumferences and segment lengths. Circumferences (in cm) will include: chest, waist, hips, upper arm, and forearm. Segment lengths (in cm) will include: shoulder to iliac spine and shoulder to wrist. All measurements will be taken using a standard anthropometric tape measure. | Day 1 |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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