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

NCT07133100 | Not Yet Recruiting

• 1 other identifier: DigitalRehab_01_2025
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (9)

• Characterization of AuReha in measuring trunk stability

  Day 1

• Characterization of AuReha in measuring limb compensation

  Day 1

• Characterization of AuReha in measuring the distance to a specified target

  Day 1

• Characterization of AuReha in measuring the duration of the movement

  Day 1

• Characterization of AuReha in terms of usability for patients with the System Usability Scale (SUS)

  Day 1

Study Arms (1)

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.

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.

patients affected by orthopedic shoulder conditions such as posterior instability, ant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

• DigitalRehab: lead

Study Sites (1)

Poliambulatorio Shoulder Team

Forlì, FC, 47122, Italy

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

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

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 20, 2025
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-08

Locations

IT (1)