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CompletedNCT04313049Updated Mar 18, 2020

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

An interventional study of JACO2 and VOCAL CONTROL in Muscular Dystrophies, sponsored by IRCCS Eugenio Medea. Completed at 1 site in Italy. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jul 2018, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
10 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Muscular Dystrophies

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03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's enrollment of 20 is below the median of 24 across 344 interventional studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

IRCCS Eugenio Medea is the lead sponsor of 104 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Motor control

    Device: JACO2

  • Experimental
    Vocal control

    Device: JACO2 · Device: VOCAL CONTROL

Interventions

  • DeviceJACO2

    Performing tasks using joystick control

  • DeviceVOCAL CONTROL

    Performing tasks using vocal control

06

What researchers measure

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.

    Time frame: immediately after application of the device

Secondary outcomes

  1. Execution Time

    Measurements of the time for tasks execution through the single experimental session

    Time frame: immediately after application of the device

  2. 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

    Time frame: immediately after application of the device

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Study locations

1 site
  • IRCCS Eugenio Medea
    Bosisio Parini, LC 23842, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04313049
Lead sponsor
IRCCS Eugenio Medea
Responsible party
Sponsor
First posted
Mar 18, 2020
Start date
Jul 1, 2018
Primary completion
Nov 15, 2019
Completion
Nov 15, 2019
Last update
Mar 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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