Study of Home Use of the Jaco Robotic Manipulation Device by Individuals With Tetraplegia (NCT07680361) | Clinical Trial Compass
CompletedNot Applicable
Study of Home Use of the Jaco Robotic Manipulation Device by Individuals With Tetraplegia
France18 participantsStarted 2022-03-30
Plain-language summary
For all individuals deprived of active and functional motor control of the upper limbs to perform grasping tasks, the restoration of a grasping function becomes a priority.
The population concerned is mainly represented by so-called functional tetraplegic individuals.
In this context, new technologies, and more particularly robotics, appear as a solution for substitution and compensation of motor impairment of the upper limb.
Assistive robotic manipulation today relies on three robot concepts that have led to commercially available products.
It is the robotic arms mounted on wheelchairs that have benefited the most from technological advances in assistive robotics over the past 15 years and from a more advanced industrial transfer than all other robotic devices. The two main ideas underlying their development are to offer, with a single robotic solution, what several technical and human aids could provide, and to allow the user to take along the "substitute" for their missing or impaired effector-namely the arm-into an unknown and non-configured environment.
The JACO arm, marketed by a Canadian company (KINOVA), now stands out on the market as one of the most promising arms in terms of functional contribution and ergonomics.
No published study has ever prospectively examined home uses related to this type of manipulator arm. Only an oral communication reports on this, suggesting, in 7 users, an impact in terms of functional gain and quality of life.
The idea that the use of the Jaco arm could reduce the time of professional caregiver intervention.
The present study aims to report on the potential uses of the Jaco robot at home, its appropriation in daily life, and its impact on psycho-social-family balance.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Functional tetraplegia (spinal cord injury, muscular dystrophy, Amyotrophic lateral sclerosis, multiple sclerosis , etc.)
* Injury duration \> 6 months
* Inability to develop full grasping ability (reaching, grasping, releasing) related to a neurological condition
* Dependent on the intervention of a professional caregiver, with an intervention level \> 4 hours per day
* User of an electric wheelchair (PWC: powered wheelchair)
* User not equipped with an assistive robotic arm
* User and caregiver demonstrating an interest in using a robotic arm and a desire for autonomy
* Provision of written, informed, signed consent
* Participant not currently in an exclusion period related to another protocol
Exclusion Criteria:
Study-specific exclusion criteria
* Participant's refusal to provide written consent
* Patient refusing the use of a robot
* Incompatibility of the participant's wheelchair or home environment
* Severe visual or hearing sensory impairments
* Significant cognitive impairment (MMSE \< 23) that may hinder learning and attention abilities
* Unstable psychiatric disorder
* Acute intercurrent illness
Non-study-specific exclusion criteria
* Participation in a therapeutic study within the month preceding inclusion
* Not affiliated with, or not benefiting from, a social security system
* Refusal to participate in the study
* Inability to provide consent
* Pregnant women
* Adults under legal protection
* Individuals deprived of liberty
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation in performance and associated satisfaction, before and after the use of the Jaco device, measured with the COPM : Canadian Occupational Performance Measure (French version)
Timeframe: Baseline : Between Day -15 and Day -10 ; Usage phase : Day 0; Day +30 and Day +60