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

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.

Study Overview

• Status: Completed
• Conditions: Muscular Dystrophies
• Intervention / Treatment: Device: JACO2; Device: VOCAL CONTROL

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • LC
    • Bosisio Parini, LC, Italy, 23842
      • IRCCS Eugenio Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Availability by the patient and /or those who take care of him/her to sign the informed consent
• Defined diagnosis of Muscular Dystrophy (Duchenne, Becker, Limb Girdle type 2, Facioscapulohumeral and congenital)
• Use of the wheelchair as a mean of movement
• Weakness in the muscular districts of the shoulder girdle and of proximal upper limb detected by MRC scale (Medical Research Council) between 0 and 3
• Cognitive skills that allow understanding and management of robot
• Aged over 10 years

Exclusion Criteria:

• Presence of important comorbidities (epilepsy, 24/24 hours dependence on non-invasive or invasive ventilotherapy)
• Behavioral and psychiatric disorders (e.g., emotional problems, depression)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Motor control	Device: JACO2; Performing tasks using joystick control
Experimental: Vocal control	Device: JACO2; Performing tasks using joystick control; Device: VOCAL CONTROL; Performing tasks using vocal control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the device (System Usability Scale)	The main outcome measure is the System Usability Scale (SUS), a validated questionnaire that measures the usability of a device, during a single experimental session, lasting no more than one hour.	immediately after application of the device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Execution Time	Measurements of the time for tasks execution through the single experimental session	immediately after application of the device
Usefulness of the device (Likert scale)	An ad hoc questionnaire (with a Likert score from 0 to 5) for the subjective evaluation of the tasks for which the robot is useful through the single experimental session	immediately after application of the device

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies
• Other Study ID Numbers: 582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No