NCT07074483

Accuracy of AuReha for Measuring Upper Limb Movements Compared to "Usual Care"

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: DigitalRehab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The clinical investigation design involves a validation study conducted on a group of healthy volunteers. It is an interventional, monocentric study with a paired data design, aimed at verifying the equivalence of the AuReha system compared to the usual care system (goniometer) in the measurement of biomechanical parameters. In addition to the measurements taken with AuReha and the goniometer, additional data collection will be carried out using the Kinovea system, which involves video analysis of recorded movement and has demonstrated high accuracy. The validation on healthy volunteers will be conducted at the Laboratory of Movement and Sport Science (LaMSS) of the IRCCS Ospedale Galeazzi-Sant'Ambrogio in Milan, and will include the recruitment of 96 volunteers from among the hospital's internal staff.

Detailed description

The primary objective of the clinical investigation is to obtain CE certification for the device. Specifically, the project aims to document the accuracy of motion measurements detected by AuReha by comparing them with the most commonly used system in current "usual care" for upper limb rehabilitation: the goniometer. At the same time, the investigation will assess the correct and timely transmission of data collected by the AuReha device within the standalone software platform, which is composed of two main functional modules: one for the subject/patient and one for healthcare professionals. These are the foundations for the optimal management of the rehabilitation process, resulting in a system capable of guiding the patient through the proper execution of rehabilitation movements as prescribed by the physician, while also collecting biomechanical parameters for close monitoring of the patient's response to the therapy. In addition to the goal of certifying the AuReha system through evidence of motion measurement accuracy, the study will also include descriptive evaluations/objectives related to user experience and the usability/wearability of the smart shirt.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Upper limb rehabilitation wearable 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.

Timeline

• Start date: 2025-06-18
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2025-07-20
• Last updated: 2025-10-01

Locations

1 site across 1 country: Italy