NCT04758520

Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation

Motor Rehabilitation of the Shoulder Complex After Orthopaedic Injury or Surgery Because of Work Accidents: a Pilot Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to validate the safety, reliability and usability of FLOAT medical device, a prototypal robotic system for the rehabilitation of the shoulder, designed and developed in the Rehab Technologies IIT-INAIL Lab to fulfil the needs orthopaedic conditions. The acceptance from patients and therapists will be assessed after a single session of robotic therapy in a sample of injured workers suffering from post-traumatic or post-surgical shoulder disorders.

Detailed description

This study aims to: 1. Test the safety and reliability of the FLOAT device for delivering post-acute motor and functional rehabilitation of patients with orthopaedic shoulder dysfunction. 2. Assess the three different modalities of utilization of the exoskeleton (Passive Mode, Learn\&Repeat Mode, Transparency Mode). 3. Evaluate the usability of the device in terms of comfort, adaptability to different patients' anthropometrics, general functioning and overall satisfaction. Six injured workers with shoulder post-traumatic and post-operative dysfunction will be enrolled in a single testing session at the INAIL Rehabilitation Center in Volterra. Pilot testing of FLOAT device will focus mainly on the feasibility of implementing the multiple operating modes of the new device, recording patients and therapist's feedback. The session will last about 3 hours and all exercises will be administered by a trained physical therapist supported by a member of the engineering team. For Aim 1, Safety and Reliability of the device will be evaluated in terms of the number of adverse events and malfunctions occurring during the study session. For Aim 2, each modality will be assessed by means of the Numeric Pain Rating Scale (NPRS), The Borg CR10 Scale Perceived Exertion (only for the Transparent mode) and ad-hoc clinician-generated questionnaires for both patients and therapists. For aim 3, patient and therapist's general evaluation about usability will be detected through a final ad-hoc questionnaire.

Conditions

• Shoulder Injuries and Disorders

Interventions

Type	Name	Description
DEVICE	FLOAT upper limb exoskeleton	The FLOAT device is composed by a wearable exoskeleton assembled on a poly-articulated arm that, in turn, is mounted on a support base with unlockable wheels. The exoskeleton includes 5 motors arranged in a way that, when generating movement, ensures the optimal involvement of all the articulations of the shoulder complex, particularly the glenohumeral and the scapulothoracic joints. According to the chosen modality of use of the exoskeleton, the device allows patient's passive or active-assisted mobilization. The poly-articulated arm supporting the exoskeleton is capable to compensate exoskeleton weight in every configuration and, if configured appropriately, permits exoskeleton use both in seated and standing positions. The support base of the device has unlockable wheels that, if unlocked, permit the free movement of the patient in the workspace, enabling the performance of more complex functional activities while assisted by the exoskeleton.

Timeline

• Start date: 2020-11-20
• Primary completion: 2022-02-21
• Completion: 2022-02-21
• First posted: 2021-02-17
• Last updated: 2022-03-31

Locations

1 site across 1 country: Italy