Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation (CRMINAIL08)

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Status: Completed

Conditions: Shoulder Injuries and Disorders

Treatments: Device: FLOAT upper limb exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT04758520

CRMINAIL08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Experimental

Experimental group

Description:

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).

Treatment:

Device: FLOAT upper limb exoskeleton