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Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients

NCT05280431 · Casa di Cura Privata del Policlinico SpA · Updated 30 Aug 2023

What is being tested
AGREE exoskeleton; FEXO exoskeleton; Conventional therapy
For
Stroke; Neurologic Disorder
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 85 years. About 48 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 25 Jan 2022, ends 31 March 2023. Registered 15 March 2022.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT05280431

Sites

  • Casa di Cura del PoliclinicoMilan, MI, Italy