HealthyNCT07074483
Accuracy of AuReha for Measuring Upper Limb Movements
A study testing Upper limb rehabilitation wearable device in people with Healthy, run by DigitalRehab at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Upper limb rehabilitation wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of AuReha for Measuring Upper Limb Movements Compared to "Usual Care". Clinical Investigation in Healthy Volunteers.
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.
Read more
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.
Read the 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
- Being tested
- Upper limb rehabilitation wearable device
- Keywords
- measurement accuracy, wearable medical device, inertial measurement sensors, upper limb rehabilitation, monitoring system, supporting system, Rehabilitation technology validation, Goniometer comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb rehabilitation wearable deviceDevice
Also called sensorized garment, wearable device for upper limb data detection
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Upper limb rehabilitation wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (9)
Equivalence in the measurement of the shoulder and elbow flexion ranges of motion
The equivalence of the measurements derived from AuReha and the instrument of comparison will be measured in degrees.
The elbow is a hinge joint formed by the articulation of the humerus with the ulna and radius. Flexion and extension occur along a coronal axis and are the two primary movements allowed by this joint. Flexion is an anterior movement that ranges from a fully extended position (0 degrees) to full flexion (approximately 145°).
Shoulder flexion is an anterior movement with a range starting from the anatomical position of 0° (arm perpendicular to the ground) up to 180° overhead. However, this final position is achieved only through a combination of movements involving both the shoulder joint and the shoulder girdle. The glenohumeral joint alone can flex to approximately 120°, while the remaining 60° are achieved through scapular abduction and lateral rotation, which reorients the glenoid cavity and allows the humerus to reach a fully vertical position.
Measured: Day 1
Characterization of AuReha in measuring movement smoothness and its timely and accurate transmission to the therapists' platform
"Movement Smoothness" is a parameter calculated by the AuRhea Web Platform and it evaluates the continuity and coordination of performed movements. It is measured through jerk, which refers to the variation in movement velocity.
Unit of Measure: Percentage (%)
The accuracy and timeliness of this parameter transfers to the AuReha Web Platform will be assessed by verifying that is registered on the platform in real time, immediately upon detection by the AuReha Sensorized Shirt.
Measured: Day 1
Characterization of AuReha in measuring movement accuracy and its timely and accurate transmission to the therapists' platform
"Movement accuracy" is a parameter calculated by the AuRhea Web Platform and it measures how precisely the volunteer performs the prescribed movements by comparing the deviation of the executed trajectory from the ideal one.
Unit of Measure: Percentage (%)
The accuracy and timeliness of this parameter transfers to the AuReha Web Platform will be assessed by verifying that is registered on the platform in real time, immediately upon detection by the AuReha Sensorized Shirt.
Measured: Day 1
Characterization of AuReha in measuring trunk stability and its timely and accurate transmission to the therapists' platform
"Trunk stability" is a parameter calculated by the AuRhea Web Platform and it assesses the inclination of the trunk across the three reference planes (frontal, sagittal, and transverse) during the execution of exercises.
Unit of Measure: Percentage (%)
The accuracy and timeliness of this parameter transfers to the AuReha Web Platform will be assessed by verifying that is registered on the platform in real time, immediately upon detection by the AuReha Sensorized Shirt.
Measured: Day 1
Characterization of AuReha in measuring limb compensation and its timely and accurate transmission to the therapists' platform
"Limb compensation" is a parameter calculated by the AuRhea Web Platform and it monitors any incorrect compensatory movements performed by the limbs during exercises.
Unit of Measure: Percentage (%)
The accuracy and timeliness of this parameter transfers to the AuReha Web Platform will be assessed by verifying that is registered on the platform in real time, immediately upon detection by the AuReha Sensorized Shirt.
Measured: Day 1
Characterization of AuReha in measuring the percentage of correct movements executed by the subject, and its timely and accurate transmission to the therapists' platform
"Percentage of correct movements" is a parameter calculated by the AuRhea Web Platform and it indicates the percentage of movements correctly performed by the volunteer in relation to the total number of goals proposed in the session. The number of proposed goals in each section varies based on the volunteer's performance, thanks to an adaptive algorithm.
Unit of Measure: Percentage (%)
The accuracy and timeliness of this parameter transfers to the AuReha Web Platform will be assessed by verifying that is registered on the platform in real time, immediately upon detection by the AuReha Sensorized Shirt.
Measured: Day 1
Correlation between AuReha shirt size (categorical: XS, S, M, L,) and the anthropometric measurements of healthy volunteers (in cm)
Evaluation of AuReha's fit on healthy volunteers, through the assessment of the correlation between the selected shirt size (categorical: XS, S, M, L) and continuous anthropometric variables, including body circumferences and segment lengths. Circumferences (in cm) will include: chest, waist, hips, upper arm, and forearm. Segment lengths (in cm) will include: shoulder to iliac spine and shoulder to wrist. All measurements will be taken using a standard anthropometric tape measure.
Measured: Day 1
Characterization of AuReha in terms of usability for healthy volunteers
Assessment of the usability of AuReha by healthy volunteers. Custom questionnaires developed for this purpose are annexed to the clinical protocol. In particular, the questionnaire collects user feedback on the AuReha App and sensorized shirt, focusing on usability, instruction clarity, and garment fit. It combines Yes/No items, a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable"), and open-text fields for qualitative insights.
Measured: Day 1
Characterization of AuReha in terms of usability for healthcare professionals
Assessment of the usability of AuReha by healthcare professionals. Custom questionnaires developed for this purpose are annexed to the clinical protocol. In particular, the surveys gauge healthcare professionals' experience with the AuReha Web Platform, assessing data transfer reliability, information clarity, user satisfaction, and decision-support effectiveness. It combines yes/no questions with open-text fields for detailed feedback.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start18 Jun 2025
- Primary completion27 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- DigitalRehab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fondazione RIDE2Med, Milan, Italy, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074483
- Sponsor's protocol ID
- DigitalRehab_01_2024
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2025
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of AuReha for Measuring Upper Limb Movements Compared to "Usual Care". Clinical Investigation in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT07074483
- Acronym / sponsor ID
- DigitalRehab_01_2024
- Conditions
- Healthy
- Keywords
- measurement accuracy, wearable medical device, inertial measurement sensors, upper limb rehabilitation, monitoring system, supporting system, Rehabilitation technology validation, Goniometer comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- DigitalRehabIndustry (pharma, biotech, devices)
- Collaborators
- Fondazione RIDE2Med, Milan, Italy, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers participants | Experimental | Device: Upper limb rehabilitation wearable deviceThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper limb rehabilitation wearable deviceAlso: sensorized garment, wearable device for upper limb data detectionThe 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. | Device | Healthy volunteers participants |
Primary outcome
The equivalence of AuReha compared to "Usual Care" (goniometer-based system) in measuring the shoulder's medio-lateral range of motion angle (abduction).
Time frame: Day 1
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.
9 secondary outcomes
Equivalence in the measurement of the shoulder and elbow flexion ranges of motion
Time frame: Day 1
Characterization of AuReha in measuring movement smoothness and its timely and accurate transmission to the therapists' platform
Time frame: Day 1
Characterization of AuReha in measuring movement accuracy and its timely and accurate transmission to the therapists' platform
Time frame: Day 1
Characterization of AuReha in measuring trunk stability and its timely and accurate transmission to the therapists' platform
Time frame: Day 1
Characterization of AuReha in measuring limb compensation and its timely and accurate transmission to the therapists' platform
Time frame: Day 1
Characterization of AuReha in measuring the percentage of correct movements executed by the subject, and its timely and accurate transmission to the therapists' platform
Time frame: Day 1
Correlation between AuReha shirt size (categorical: XS, S, M, L,) and the anthropometric measurements of healthy volunteers (in cm)
Time frame: Day 1
Characterization of AuReha in terms of usability for healthy volunteers
Time frame: Day 1
Characterization of AuReha in terms of usability for healthcare professionals
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb rehabilitation wearable device in people with Healthy, run by DigitalRehab at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The equivalence of AuReha compared to "Usual Care" (goniometer-based system) in measuring the shoulder's medio-lateral range of motion angle (abduction). (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.