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Muscular DystrophiesNCT04313049

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

A study testing JACO2 in people with Muscular Dystrophies, run by IRCCS Eugenio Medea at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Muscular Dystrophies
What is being tested?
JACO2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Jul 2018to 15 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Eugenio Medea

    Bosisio Parini, LC, 23842

Other trials in Italy

About this study

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.

Being tested
JACO2, VOCAL CONTROL
Medical subject headings
Muscular Dystrophies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JACO2Device

    Performing tasks using joystick control

  • VOCAL CONTROLDevice

    Performing tasks using vocal control

Study groups in NCT04313049
Study groupRoleWhat they receive
Motor controlActive comparatorNot described
Receives: Device: JACO2
Vocal controlExperimentalNot described
Receives: Device: JACO2; Device: VOCAL CONTROL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately after application of the device

Secondary outcomes (2)
  1. Execution Time

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

    Measured: 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

    Measured: immediately after application of the device

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start1 Jul 2018
  3. Primary completion15 Nov 2019
  4. Study completion15 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313049
Sponsor's protocol ID
582
Status last verified
Mar 2020
First submitted
25 Feb 2020
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing JACO2 in people with Muscular Dystrophies, run by IRCCS Eugenio Medea at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability of the device (System Usability Scale) (time frame: immediately after application of the device). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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