Status:
COMPLETED
Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation
Lead Sponsor:
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Collaborating Sponsors:
Istituto Italiano di Tecnologia
Conditions:
Shoulder Injuries and Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04758520
Start Date
November 20 2020
End Date
February 21 2022
Last Update
March 31 2022
Active Locations (1)
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1
INAIL - Centro di Riabilitazione Motoria di Volterra
Volterra, Pisa, Italy, 56048