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

DigitalRehab

Status: Enrolling

Conditions: Healthy

Treatments: Device: Upper limb rehabilitation wearable device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07074483

DigitalRehab_01_2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Volunteers who provide written informed consent to participate in the study
• Absence of movement limitations affecting the upper limbs and/or trunk

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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96 participants in 1 patient group

Healthy volunteers participants

Experimental group

Description:

This arm includes healthy adult volunteers who will perform a series of upper limb rehabilitation exercises using the AuReha system, as the aim of the study is to evaluate the accuracy of the device in capturing upper limb joint movements, as well as to assess the usability and user experience of the wearable system. 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