NCT04313049

LARA: Use of JACO2 Controlled by Joystick or by Voice Control System, in Muscular Dystrophy

Completed NA Last updated 18 March 2020

What this trial tests

NA trial testing JACO2 in Muscular Dystrophies in 20 participants. Completed in 15 November 2019.

Timeline

1 July 2018

Primary endpoint
15 November 2019

15 November 2019

Quick facts

Lead sponsor	IRCCS Eugenio Medea
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	20
Start date	1 July 2018
Primary completion	15 November 2019
Estimated completion	15 November 2019
Sites	1 location across Italy

Drugs / interventions tested

• JACO2
• VOCAL CONTROL

Conditions studied

• Muscular Dystrophies — all drugs for Muscular Dystrophies →

Sponsor

IRCCS Eugenio Medea — full company profile →

Who can join

10 and older, any sex, with Muscular Dystrophies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

As part of the EMPATIA @ Lecco project, task 2.9 and task 4.5 respectively provide for the refinement and testing of robotic solutions on the market oriented towards patient empowerment. Within the LARA project, the JACO2 mechanical arm (Kinova Technology, Montreal, QC, Canada), a medical device, which can perform some functions as if it were the subject's arm, will be tested. JACO2 can be controlled by joystick, supplied with the system, or by voice control system, developed by CNR-ITIA to allow use even for those with severe strength impairments. The trial will involve patients with Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD), Limb Girdle Muscular Dystrophy (LGMD), congenital and Facioscapulohumeral Muscular Dystrophy (FSH) over the age of 10 years. In literature of the last decade we find evidence of social and personal benefits deriving from the use of assistive mechanical arms in daily life activities by patients with disabilities due to neuromuscular diseases. The results indicate improved quality of life, greater self-esteem and greater integration into society. In addition to the benefits for the person, it has been shown that the introduction of assistive technologies in the life of patients can lead to potential savings on direct and indirect costs of National Health Services. Assistive robotic arms have a potential user base of approximately 150,000 people only in the United States of America. This population includes subjects who have partially lost the function of the upper limb due to degenerative diseases or because of spinal cord injuries or infantile cerebral palsy. The number of potential users could increase by improving the usability of these systems that, at the moment, still require a certain functionality of the upper limb, in general, and of the hand, in particular. It is in fact known that the introduction of assistive technologies in daily life is not limited so much by the fact that patients do not accept or profit from them, but rather by the actual possibility of using them effectively. Therefore, a customization of the functionality of the devices based on needs and wishes of the patients alongside an improvement in their usability would lead to an increase in potential users. It is for this reason that usability, together with safety, has become one of the most studied topics in assistive robotics. In the case of assistive robotic manipulators, usability problems often concern their control which, even today, takes place through the use of joysticks that require fine motor skills in the hand. In fact, being systems with multiple degrees of freedom, that is, equipped with different segments that can translate (or rotate) in different directions, different buttons are integrated in the control joysticks in addition to the classic lever with knob. From this emerges the need to develop alternative joystick control methods that do not involve the use of the hand.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Testing the usability of a voice control system for assistive robotic arms in people with neurological conditions.
   Pulikottil T, Biffi E, Diella E, Dangelo MG, et al · · 2026 · PMID 41652513 · DOI 10.1186/s12984-026-01902-1