Clinical trial NCT04758520: Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation
Official title: Motor Rehabilitation of the Shoulder Complex After Orthopaedic Injury or Surgery Because of Work Accidents: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: Istituto Italiano di Tecnologia
First posted: 2021-02-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Number of adverse events
timeFrame: 1 year
measure: Number of device malfunctions
timeFrame: 1 year
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 1 year
measure: The Borg Category-Ratio Scale (CR-10)
timeFrame: 1 year
measure: Ad-hoc questionnaires for the patient, one for each of the three modalities (for a total amount of 3 questionnaires)
timeFrame: After the completion of the testing session with each of the three modalities
measure: Ad-hoc questionnaires for the therapist, one for each of the three modalities (for a total amount of 3 questionnaires)
timeFrame: 1 year
measure: Ad-hoc questionnaire for the patient (final evaluation)
timeFrame: 1 year (at the end of the study)
measure: Ad-hoc questionnaire for the therapist (final evaluation)
timeFrame: 1 year (at the end of the study)
Other outcomes:
Locations:
city: Volterra
country: Italy
facility: INAIL - Centro di Riabilitazione Motoria di Volterra
state: Pisa
Study officials:
affiliation: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
name: Elisa Taglione, MD
role: PRINCIPAL_INVESTIGATOR
References: