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

Primary Purpose

Muscular Dystrophies

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
JACO2
VOCAL CONTROL
Sponsored by
IRCCS Eugenio Medea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscular Dystrophies

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • IRCCS Eugenio Medea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Motor control

Vocal control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2020
Last Updated
March 16, 2020
Sponsor
IRCCS Eugenio Medea
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1. Study Identification

Unique Protocol Identification Number
NCT04313049
Brief Title
LARA: Use of JACO2 Controlled by Joystick or by Voice Control System, in Muscular Dystrophy
Official Title
LARA: Use of JACO2 Controlled by Joystick or by Voice Control System, in Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor control
Arm Type
Active Comparator
Arm Title
Vocal control
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
JACO2
Intervention Description
Performing tasks using joystick control
Intervention Type
Device
Intervention Name(s)
VOCAL CONTROL
Intervention Description
Performing tasks using vocal control
Primary Outcome Measure Information:
Title
Usability of the device (System Usability Scale)
Description
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 Outcome Measure Information:
Title
Execution Time
Description
Measurements of the time for tasks execution through the single experimental session
Time Frame
immediately after application of the device
Title
Usefulness of the device (Likert scale)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
IRCCS Eugenio Medea
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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