Evaluation of ORTHOPUS Partner Arm in People With Disabilities Needing for Robotic Assistance to Compensate for Upper Limb Deficiency

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate how well a robotic assistance device, called ORTHOPUS, can help people with upper limb disabilities. The goal is to see if this device can improve daily activities for those who have limited use of their arms. The study will involve multiple centers and will be open to all genders, focusing on participants aged 21 and older who have lost mobility in their upper limbs.

To join the trial, participants must have very limited movement in their arms, as measured by a specific scale, and be able to show some effective movements with the device. It's important for participants to be able to understand the trial and provide consent, or have a guardian do so if they are minors. Additionally, a family member must be present during the setup visit, and someone will need to record videos of how the device is used in everyday life. Those with certain cognitive issues, recent arm fractures, or who are already in another clinical study won't be able to participate. This is an exciting opportunity to help researchers learn more about improving mobility for people with disabilities!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a loss of mobility in the upper limb (UL).
• • Have minimal functional capacities in the upper limb, defined by a score between 1 and 4 on the Lovett scale for all muscle groups of the arm, except for the hand and wrist.
• • Demonstrate effective distal motor skills in the upper limb to be fitted.
• • Be an informed patient who has provided signed consent, or in the case of minors, have given assent along with the signed consent of legal guardians.
• • A relative must be available for the installation visit, and either the patient or the relative must have the necessary equipment to record videos in ecological conditions (smartphone or tablet).)
• Exclusion Criteria:
• • Patients with cognitive or behavioral dysfunctions that may compromise adherence to instructions and procedures required for the trial (at the discretion of the investigator clinician).
• • Patients already enrolled in an interventional clinical trial.
• • History of fractures in the upper limb to be fitted within the six months preceding the inclusion visit in the trial.
• • Any conditions or injuries that may interfere with functional assessments.
• • Patients under legal guardianship or curatorship.
• • Lack of health insurance coverage.