Shoulder Posterior InstabilityNCT07133100
Evaluating Upper Limb Movement Precision With AuReha in People With One-Sided Motor Impairment
A study testing Upper limb rehabilitation wearable device in people with Shoulder Posterior Instability and Shoulder Anterior Instability, run by DigitalRehab at 1 site in Italy.
Trial summary
The clinical investigation is designed as a controlled, two-arm, intra-patient, non-randomized interventional study aimed at assessing the capabilities of the AuReha system in detecting upper limb movement precision in patients with unilateral proprioceptive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Posterior Instability, Shoulder Anterior Instability, Shoulder Anterior Latarjet Instability
- 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
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a healthy contralateral limb
- patients affected by orthopedic shoulder conditions such as posterior instability, anterior instability, anterior Latarjet instability, adhesive capsulitis, or prostheses
- age ≥18 years
- patients who consent to participate in the study by signing the informed consent form
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. Contact the study team or a site near you to ask about taking part.
Italy1 site
Poliambulatorio Shoulder Team
Forlì, FC, 47122
Fiumana, +39 3479405736, g.fiumana@gmail.com
About this study
Official title: Intrasubject Evaluation of Upper Limb Movement Precision Using the AuReha System in Individuals With Unilateral Motor Impairment
The clinical investigation is designed as a controlled, two-arm, intra-patient, non-randomized interventional study aimed at assessing the capabilities of the AuReha system in detecting upper limb movement precision in patients with unilateral proprioceptive impairment. The comparison will be conducted within the same subject, between the healthy limb and the impaired limb, through the execution of proprioceptive exercises in an open kinetic chain. The biomechanical parameters collected will include movement precision, trunk stability, compensatory movements, and joint range of motion. In addition to the quantitative analysis, qualitative data will also be collected regarding usability, wearability, and user experience of the system through questionnaires administered to both patients and healthcare professionals.
The study will be conducted at the Shoulder Team Outpatient Clinic in Forlì, enrolling approximately 52 patients.
Read the detailed description
The primary goal of this clinical investigation is to support the CE certification process of the AuReha system, a wearable medical device designed for monitoring upper limb movement during rehabilitation.
Specifically, the study aims to assess the movement precision of the upper limb in individuals with unilateral motor impairment. The main objective is to compare, within the same individual, the movement accuracy of the healthy arm versus the impaired arm during a series of rehabilitation exercises guided by the AuReha system.
Secondary objectives include:
- Evaluating the usability of the AuReha system in clinical practice from the perspective of healthcare professionals using the Healthcare Systems Usability Scale (HSUS) and additional targeted questions.
- Assessing patients' user experience during proprioceptive exercises, through the System Usability Scale (SUS), the User Engagement Scale - Short Form (UES-SF), and other custom questions.
- Characterizing the wearability of the device by matching shirt sizes with patients' anthropometric measurements, using both direct observations and questionnaires.
- Analyzing the movement data collected during a specific reaching task prompted by the AuReha system, to gain deeper insight into the quality and precision of the movement performed.
These aspects aim to demonstrate the system's ability to support an optimized rehabilitation process. AuReha is designed to help patients perform their prescribed rehabilitation exercises correctly while collecting detailed biomechanical data. This allows clinicians to closely monitor the patient's response to therapy and make data-driven decisions throughout the recovery process.
- Conditions
- Shoulder Posterior Instability, Shoulder Anterior Instability, Shoulder Anterior Latarjet Instability, Adhesive Capsulitis, Shoulder, Prostheses
- Being tested
- Upper limb rehabilitation wearable device
- Keywords
- wearable medical device, upper limb rehabilitation, inertial measurement sensors, monitoring system, supporting system, shoulder rehabilitation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb rehabilitation wearable deviceDevice
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 |
|---|---|---|
| patients affected by orthopedic shoulder conditions such as posterior instability, ant | Experimental | The clinical investigation is designed as an interventional, controlled, two-arm intra-patient, non-randomized study aimed at evaluating the capabilities of the AuReha system in detecting the accuracy of upper limb movements in patients with unilateral proprioceptive deficits. The comparison will be conducted within the same subject between the healthy limb and the affected limb, through the performance of proprioceptive exercises in open kinetic chain. 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.
Evaluation of the intra-subject difference in movement accuracy during a target-reaching exercise proposed by the AuReha system, between the healthy limb and the limb affected by motor deficit
Unit of measurement: Percentage (%) - Movement accuracy, expressed as a percentage, measures how precisely the patient performs the prescribed movements, by assessing the deviation of the executed movement from the ideal movement to be performed.
Measured: Day 1
Secondary outcomes (9)
Characterization of AuReha in measuring trunk stability
Trunk stability is a parameter calculated by the AuReha Web Platform that assesses the inclination of the trunk across the three reference planes (frontal, sagittal, and transverse) during exercise execution. Trunk stability is an essential parameter to ensure the correct performance of upper limb movements and to prevent harmful compensations that could negatively impact recovery.
Unit of Measure: Percentage (%)
Measured: Day 1
Characterization of AuReha in measuring limb compensation
Limb compensation is a parameter calculated by the AuReha Web Platform that monitors any incorrect compensatory movements performed by the limbs during exercises. For example, it can detect shoulder elevation during elbow flexion, or elbow flexion during shoulder movements. This parameter is crucial for identifying and correcting dysfunctional movement patterns that could compromise the rehabilitation process.
Unit of Measure: Percentage (%)
Measured: Day 1
Characterization of AuReha in measuring the distance to a specified target
This parameter evaluates the final distance from the target to be reached. Unit of Measure: Percentage (%)
Measured: Day 1
Characterization of AuReha in measuring the duration of the movement
This parameter calculates the duration of movement execution. Unit of Measure: seconds (s)
Measured: Day 1
Characterization of AuReha in terms of usability for patients with the System Usability Scale (SUS)
Assessment of the usability of AuReha by enrolled patients during the evaluation and execution of proprioceptive exercises.
Standardized questionnaires will be used (SUS). The questionnaire assesses usability and overall user experience. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable").
Measured: Day 1
Characterization of AuReha in terms of usability for patients with the User Engagement Scale - Short Form (UES-SF)
Assessment of the usability of AuReha by enrolled patients during the evaluation and execution of proprioceptive exercises.
Standardized questionnaires will be used (UES-SF). This questionnaire collects user feedback on the AuReha App and the sensorized shirt, focusing on the engagement. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable").
Measured: Day 1
Characterization of AuReha in terms of usability for patients
Assessment of the usability of AuReha by enrolled patients during the evaluation and execution of proprioceptive exercises.
Custom questionnaires have been developed for this purpose and are annexed to the clinical protocol. These questionnaires collect user feedback on the AuReha App and the sensorized shirt, focusing on usability, engagement, clarity of instructions, and garment fit. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable"), and include open-text fields for qualitative insights.
Measured: Day 1
Characterization of AuReha in terms of usability for healthcare professionals
Standardized questionnaires will be used, specifically the Healthcare System Usability Scale (HSUS). In addition, custom questionnaires have been developed for this purpose and are annexed to the clinical protocol. These questionnaires collect user feedback on the AuReha App and the sensorized shirt, focusing on usability and clarity of instructions. Responses are based on a 0-4 Likert difficulty scale (from "no difficulty" to "system unusable") and include open-text fields for qualitative insights.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Posterior InstabilityStudies 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
- Model description
- The study has a two-arm intra-patient design, as the comparison will be made within the same subject between the healthy limb and the affected limb.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DigitalRehab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133100
- Sponsor's protocol ID
- DigitalRehab_01_2025
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrasubject Evaluation of Upper Limb Movement Precision Using the AuReha System in Individuals With Unilateral Motor Impairment
- ClinicalTrials.gov ID
- NCT07133100
- Acronym / sponsor ID
- DigitalRehab_01_2025
- Conditions
- Shoulder Posterior Instability, Shoulder Anterior Instability, Shoulder Anterior Latarjet Instability, Adhesive Capsulitis, Shoulder, Prostheses
- Keywords
- wearable medical device, upper limb rehabilitation, inertial measurement sensors, monitoring system, supporting system, shoulder rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- DigitalRehabIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Aug 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 is designed as a controlled, two-arm, intra-patient, non-randomized interventional study aimed at assessing the capabilities of the AuReha system in detecting upper limb movement precision in patients with unilateral proprioceptive impairment. The comparison will be conducted within the same subject, between the healthy limb and the impaired limb, through the execution of proprioceptive exercises in an open kinetic chain. The biomechanical parameters collected will include movement precision, trunk stability, compensatory movements, and joint range of motion. In addition to the quantitative analysis, qualitative data will also be collected regarding usability, wearability, and user experience of the system through questionnaires administered to both patients and healthcare professionals.
The study will be conducted at the Shoulder Team Outpatient Clinic in Forlì, enrolling approximately 52 patients.
Detailed description
The primary goal of this clinical investigation is to support the CE certification process of the AuReha system, a wearable medical device designed for monitoring upper limb movement during rehabilitation.
Specifically, the study aims to assess the movement precision of the upper limb in individuals with unilateral motor impairment. The main objective is to compare, within the same individual, the movement accuracy of the healthy arm versus the impaired arm during a series of rehabilitation exercises guided by the AuReha system.
Secondary objectives include:
- Evaluating the usability of the AuReha system in clinical practice from the perspective of healthcare professionals using the Healthcare Systems Usability Scale (HSUS) and additional targeted questions.
- Assessing patients' user experience during proprioceptive exercises, through the System Usability Scale (SUS), the User Engagement Scale - Short Form (UES-SF), and other custom questions.
- Characterizing the wearability of the device by matching shirt sizes with patients' anthropometric measurements, using both direct observations and questionnaires.
- Analyzing the movement data collected during a specific reaching task prompted by the AuReha system, to gain deeper insight into the quality and precision of the movement performed.
These aspects aim to demonstrate the system's ability to support an optimized rehabilitation process. AuReha is designed to help patients perform their prescribed rehabilitation exercises correctly while collecting detailed biomechanical data. This allows clinicians to closely monitor the patient's response to therapy and make data-driven decisions throughout the recovery process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study has a two-arm intra-patient design, as the comparison will be made within the same subject between the healthy limb and the affected limb.
| Arm | Type | Receives |
|---|---|---|
| patients affected by orthopedic shoulder conditions such as posterior instability, ant | Experimental | Device: Upper limb rehabilitation wearable deviceThe clinical investigation is designed as an interventional, controlled, two-arm intra-patient, non-randomized study aimed at evaluating the capabilities of the AuReha system in detecting the accuracy of upper limb movements in patients with unilateral proprioceptive deficits. The comparison will be conducted within the same subject between the healthy limb and the affected limb, through the performance of proprioceptive exercises in open kinetic chain. 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a healthy contralateral limb
- patients affected by orthopedic shoulder conditions such as posterior instability, anterior instability, anterior Latarjet instability, adhesive capsulitis, or prostheses
- age ≥18 years
- patients who consent to participate in the study by signing the informed consent form
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 deviceThe 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 | patients affected by orthopedic shoulder conditions such as posterior instability, ant |
Primary outcome
Evaluation of the intra-subject difference in movement accuracy during a target-reaching exercise proposed by the AuReha system, between the healthy limb and the limb affected by motor deficit
Time frame: Day 1
Unit of measurement: Percentage (%) - Movement accuracy, expressed as a percentage, measures how precisely the patient performs the prescribed movements, by assessing the deviation of the executed movement from the ideal movement to be performed.
9 secondary outcomes
Characterization of AuReha in measuring trunk stability
Time frame: Day 1
Characterization of AuReha in measuring limb compensation
Time frame: Day 1
Characterization of AuReha in measuring the distance to a specified target
Time frame: Day 1
Characterization of AuReha in measuring the duration of the movement
Time frame: Day 1
Characterization of AuReha in terms of usability for patients with the System Usability Scale (SUS)
Time frame: Day 1
Characterization of AuReha in terms of usability for patients with the User Engagement Scale - Short Form (UES-SF)
Time frame: Day 1
Characterization of AuReha in terms of usability for patients
Time frame: Day 1
Characterization of AuReha in terms of usability for healthcare professionals
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Scapular Dyskinesis, Posterior Shoulder Instability
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.
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 Shoulder Posterior Instability and Shoulder Anterior Instability, 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 4 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: opening soon, as of the sponsor's last update on 1 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the intra-subject difference in movement accuracy during a target-reaching exercise proposed by the AuReha system, between the healthy limb and the limb affected by motor deficit (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 1 Oct 2025.