Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation

NCT ID: NCT04758520

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2022-02-21

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Experimental

Six subjects are involved in a single session of upper limb robotic-assisted therapy lasting about 3 hours and including:

• passive mobilization of patient's upper arm along elementary shoulder movements:shoulder flexion/extension, adduction/ abduction in the frontal plane, horizontal adduction/ abduction, intra/extrarotation (Passive Mode);
• passive mobilization of patient's upper arm along complex trajectories recorded from manual mobilization of the therapist (Learn&Replay Mode);
• active mobilization, performed by the patient during rehabilitative functional tasks, relying only on gravity and friction compensations and tuneable assistance from the exoskeleton (Transparency Mode).

Group Type: EXPERIMENTAL

FLOAT upper limb exoskeleton

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Height between 160 and 185 cm;
• Distance between the shoulder joint center and the sagittal plane between 156 and 197 mm;
• Shoulder joint center to wall distance between 82 and 142 mm
• Maximum shoulter radius: 120 mm
• Distance between the shoulder joint center and the elbow joint center between 250 and 303 mm
• Time from acute event ≥ 60 days
• Right shoulder joint disfunction after orthopaedic injury or surgery as a result of work accidents
• Post-immobilization phase
• At least 80° shoulder passive flexion and 45° shoulder passive abduction
• Pain intensity on movement < 6 NRS;

Exclusion Criteria

• Glenohumeral joint instability
• Shoulder Prosthetic implants
• Upper arm sensorimotor deficits
• Chronic inflammatory disorder involving upper arm joints
• Pseudoarthrosis of the proximal humerus fractures
• Spinal fractures within the last 3 months
• Open skin at the level of the patient-device interface
• Current or prior history of malignancy
• Pregnancy or breast feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Italiano di Tecnologia

OTHER

Sponsor Role: collaborator

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisa Taglione, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Locations

INAIL - Centro di Riabilitazione Motoria di Volterra

Volterra, Pisa, Italy

Countries

Italy

Other Identifiers

CRMINAIL08

Identifier Type: -

Identifier Source: org_study_id