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

NCT04313049 | Completed

• 1 other identifier: 582
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscular Dystrophies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Execution Time

  immediately after application of the device

• Usefulness of the device (Likert scale)

  immediately after application of the device

Study Arms (2)

Motor control

ACTIVE COMPARATOR

Device: JACO2

Vocal control

EXPERIMENTAL

Device: JACO2; Device: VOCAL CONTROL

Interventions

JACO2 DEVICE

Performing tasks using joystick control

Motor control; Vocal control

VOCAL CONTROL DEVICE

Performing tasks using vocal control

Vocal control

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

Location

MeSH Terms

Conditions

Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 18, 2020
• Study Start: July 1, 2018
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)