Accuracy of AuReha for Measuring Upper Limb Movements

NCT07074483 | Completed

• 1 other identifier: DigitalRehab_01_2024
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

measurement accuracy; wearable medical device; inertial measurement sensors; upper limb rehabilitation; monitoring system; supporting system; Rehabilitation technology validation; Goniometer comparison

Outcome Measures

Primary Outcomes (1)

• The equivalence of AuReha compared to "Usual Care" (goniometer-based system) in measuring the shoulder's medio-lateral range of motion angle (abduction).

  The shoulder joint, also known as the glenohumeral joint, is a ball-and-socket type articulation formed by the head of the humerus and the glenoid cavity of the scapula. Flexion and extension are movements that occur around the coronal axis. Abduction and adduction are movements that occur around the sagittal axis. Abduction is a lateral movement ranging from 0° (arm perpendicular to the floor) to a vertical position above the head (approximately 180°). This final position is equivalent to that reached during flexion and involves the coordinated movement of the shoulder girdle and the glenohumeral joint.

  Day 1

Secondary Outcomes (9)

• Equivalence in the measurement of the shoulder and elbow flexion ranges of motion

  Day 1

• Characterization of AuReha in measuring movement smoothness and its timely and accurate transmission to the therapists' platform

  Day 1

• Characterization of AuReha in measuring movement accuracy and its timely and accurate transmission to the therapists' platform

  Day 1

• Characterization of AuReha in measuring trunk stability and its timely and accurate transmission to the therapists' platform

  Day 1

• Characterization of AuReha in measuring limb compensation and its timely and accurate transmission to the therapists' platform

  Day 1

Study Arms (1)

Healthy volunteers participants

EXPERIMENTAL

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.

Device: Upper limb rehabilitation wearable device

Interventions

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.

Also known as: sensorized garment, wearable device for upper limb data detection

Healthy volunteers participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione RIDE2Med, Milan, Italy: collaborator
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator
• DigitalRehab: lead

Study Sites (1)

IRCCS Ospedale Galeazzi - Sant'Ambrogio

Milan, Italy, 20157, Italy

Location

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 20, 2025
• Study Start: June 18, 2025
• Primary Completion: November 27, 2025
• Study Completion: December 10, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

IT (1)