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Completed
NCT07680361
Study of Home Use of the Jaco Robotic Manipulation Device by Individuals With Tetraplegia
Conditions: Tetraplegia, Functional Tetraplegia, Spinal Cord Injury, Muscular Dystrophy, ALS (Amyotrophic Lateral Sclerosis), Multiple Sclerosis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 18
Sponsor: Association APPROCHE
Location: Centre Bouffard Vercelli Perpignan
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07680361). StuddyBuddy aggregates publicly available trial information.