Evaluating Upper Limb Movement Precision With AuReha in People With One-Sided Motor Impairment

DigitalRehab

Status: Not yet enrolling

Conditions: Shoulder Posterior Instability; Adhesive Capsulitis, Shoulder; Prostheses; Shoulder Anterior Latarjet Instability; Shoulder Anterior Instability

Treatments: Device: Upper limb rehabilitation wearable device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07133100

DigitalRehab_01_2025

Details and patient eligibility

About

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.

Full description

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:

• Evaluating the usability of the AuReha system in clinical practice from the perspective of healthcare professionals using the Healthcare Systems Usability Scale (HSUS) and additional targeted questions.
• Assessing patients' user experience during proprioceptive exercises, through the System Usability Scale (SUS), the User Engagement Scale - Short Form (UES-SF), and other custom questions.
• Characterizing the wearability of the device by matching shirt sizes with patients' anthropometric measurements, using both direct observations and questionnaires.
• Analyzing the movement data collected during a specific reaching task prompted by the AuReha system, to gain deeper insight into the quality and precision of the movement performed.

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

patients affected by orthopedic shoulder conditions such as posterior instability, ant

Experimental group

Description:

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.

Treatment:

Device: Upper limb rehabilitation wearable device