Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients — PCP_EXOs  

Stroke Clinical Trial

Official title: Evaluation of the Use of Exoskeleton Systems for Upper Limb Rehabilitation in Neurological Patients

Status Completed

Clinical Trial Summary

Acquired cerebrovascular trauma is the third most common cause of disability worldwide, resulting in long-term disability, limitation of activities of daily living, and reduced social participation. It is estimated that, within three months of the acute event, a high percentage of patients do not recover full function. 93% of these disabilities concern the upper limb.

To induce optimal functional reorganization after the acute cerebrovascular events or neurodegenerative diseases affecting the central nervous system, robotic assistance allows intensive exercises with specific therapeutic purposes. Indeed, they enable an intensive, repetitive, and customizable therapeutic program that is in line with the principles underlying motor learning.

Clinical investigation is needed to assess the efficacy of the proposed new technologies (AGREE and FEXO exoskeleton) and to guide subsequent developmental steps. Therefore, an exploratory clinical study is proposed to evaluate usability, tolerability, and safety, as well as to assess the effectiveness of the new technologies.

The primary objective of this study is to examine the safety and tolerability of the new active exoskeletons for upper extremity rehabilitation and validate them in a controlled environment. Furthermore, efficacy will be examined as the secondary outcome.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorder
• Stroke

• NCT number: NCT05280431
• Study type: Interventional
• Source: Casa di Cura Privata del Policlinico SpA
• Status: Completed
• Phase: N/A
• Start date: January 25, 2022
• Completion date: March 31, 2023