Accuracy of AuReha for Measuring Upper Limb Movements Compared to "Usual Care"
NCT ID: NCT07074483
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2025-06-18
2025-11-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Healthy volunteers participants
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Volunteers who provide written informed consent to participate in the study
* Absence of movement limitations affecting the upper limbs and/or trunk
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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DigitalRehab
INDUSTRY
Responsible Party
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Locations
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IRCCS Ospedale Galeazzi - Sant'Ambrogio
Milan, Italy, Italy
Countries
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Facility Contacts
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Other Identifiers
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DigitalRehab_01_2024
Identifier Type: -
Identifier Source: org_study_id
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