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Starting soon Not applicable

Evaluating Upper Limb Movement Precision With AuReha in People With One-Sided Motor Impairment

NCT07133100 · tracked via the Priya Life Science Italy tracker
Sponsor
DigitalRehab
Phase
Not applicable
Started
2025-10
Last updated
2025-10-01

Condition(s) studied

Shoulder Posterior InstabilityShoulder Anterior InstabilityShoulder Anterior Latarjet InstabilityAdhesive Capsulitis, ShoulderProstheses

Investigational drug(s) / intervention(s)

Upper limb rehabilitation wearable 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.

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Poliambulatorio Shoulder Team Forlì FC
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07133100 on ClinicalTrials.gov ↗ ← All trials in Italy