Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04758520
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation
Sponsor:
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Organization:
Study Overview
Official Title:
Motor Rehabilitation of the Shoulder Complex After Orthopaedic Injury or Surgery Because of Work Accidents: a Pilot Study.
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRMINAIL08
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: