AGREE: an upper limb motorized exoskeleton for restoring arm functions: a single-blinded randomized controlled trial

Area of Science:

• Neuroscience
• Rehabilitation Engineering
• Clinical Neurology

Background:

• Technology-assisted neurorehabilitation is crucial for managing healthcare overload.
• Effectiveness of upper-limb exoskeletons requires further clinical validation.
• Innovative prototypes like the AGREE exoskeleton need rigorous testing.

Purpose of the Study:

• To evaluate the AGREE exoskeleton, a novel motorized upper-limb assistive device.
• To compare the AGREE system's effectiveness against standard care in neurological patients.
• To assess usability, clinical outcomes, and treatment dosage of the AGREE system.

Main Methods:

• A randomized controlled trial involving 32 neurological patients with upper limb motor deficits.
• Participants received 15 training sessions, allocated to either the AGREE exoskeleton or standard care.
• Outcome measures included the System Usability Scale, Fugl-Meyer Assessment, Action Research Arm Test, Motricity Index, and Box and Block Test.

Main Results:

• The AGREE system reported moderate usability (median SUS score = 68.7).
• Both groups demonstrated significant, comparable clinical improvements across all assessed measures.
• The experimental group achieved comparable outcomes with significantly less actual treatment time.

Conclusions:

• The AGREE exoskeleton is safe and usable for neurorehabilitation.
• AGREE system and standard care yielded comparable clinical improvements.
• Therapy consistency and frequency may be more critical than session duration for neurorehabilitation outcomes.