Evaluating Upper Limb Movement Precision With AuReha in People With One-Sided Motor Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Upper limb rehabilitation wearable device.
- Who it may be relevant to
- Registry conditions: Shoulder Posterior Instability, Shoulder Anterior Instability, Shoulder Anterior Latarjet Instability, Adhesive Capsulitis, Shoulder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrasubject Evaluation of Upper Limb Movement Precision Using the AuReha System in Individuals With Unilateral Motor Impairment
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- 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]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Poliambulatorio Shoulder Team — Forlì
Identifiers
NCT: NCT07133100 · DigitalRehab_01_2025