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Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation

NCT04758520 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Shoulder Injuries and Disorders

Interventions

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.

Sponsors & Collaborators

  • Istituto Italiano di Tecnologia

    collaborator OTHER

  • Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

    lead OTHER

Principal Investigators

  • Elisa Taglione, MD · Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2022-02-21
Completion
2022-02-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758520 on ClinicalTrials.gov