Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation (NCT04758520) | Clinical Trial Compass
CompletedNot Applicable
Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation
Italy6 participantsStarted 2020-11-20
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse events
Timeframe: 1 year
2
Number of device malfunctions
Timeframe: 1 year
Trial details
NCT IDNCT04758520
SponsorIstituto Nazionale Assicurazione contro gli Infortuni sul Lavoro