Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation

NCT04758520 | Completed

• 1 other identifier: CRMINAIL08
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Injuries and Disorders

Keywords

Adult; Deseases/musculoskeletal; Feasibility Studies; Humans; Occupational Therapy; Rehabilitation Research; Robotics; Shoulder Joint / therapy; Upper arm/therapy; Wearable devices

Outcome Measures

Primary Outcomes (2)

• Number of adverse events

  The physiotherapist is required to report any adverse events occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the safety of the device

  1 year

• Number of device malfunctions

  The physiotherapist is required to report any malfunctions occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the reliability of the device

  1 year

Secondary Outcomes (6)

• Numeric Pain Rating Scale (NPRS)

  1 year

• The Borg Category-Ratio Scale (CR-10)

  1 year

• Ad-hoc questionnaires for the patient, one for each of the three modalities (for a total amount of 3 questionnaires)

  After the completion of the testing session with each of the three modalities

• Ad-hoc questionnaires for the therapist, one for each of the three modalities (for a total amount of 3 questionnaires)

  1 year

• Ad-hoc questionnaire for the patient (final evaluation)

  1 year (at the end of the study)

Study Arms (1)

Experimental

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).

Device: FLOAT upper limb exoskeleton

Interventions

FLOAT upper limb exoskeleton 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.

Experimental

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: lead
• Istituto Italiano di Tecnologia: collaborator

Study Sites (1)

INAIL - Centro di Riabilitazione Motoria di Volterra

Volterra, Pisa, 56048, Italy

Location

MeSH Terms

Conditions

Shoulder Injuries; Disease

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisa Taglione, MD

  Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 17, 2021
• Study Start: November 20, 2020
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)