Study of Home Use of the Jaco Robotic Manipulation Device by Individuals With Tetraplegia (TETRAJACO)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; ALS (Amyotrophic Lateral Sclerosis); Muscular Dystrophy; Spinal Cord Injury; Tetraplegia; Functional Tetraplegia
• Intervention / Treatment: Device: Use of the JACO robotic arm for a period of 2 months

Detailed Description

For individuals with complete loss of active and functional upper limb motor abilities required to perform grasping tasks, the restoration of grasping function is a critical priority.

In this context, emerging technologies-and more specifically robotics-offer promising solutions for compensating upper limb motor impairment. The target population primarily consists of individuals with functional tetraplegia , resulting either from high-level cervical spinal cord injury or from severe neuromuscular or peripheral neurological disorders. In the vast majority of cases, these individuals are dependent on powered wheelchairs.

In cases of high cervical spinal cord injury, individuals with tetraplegia present extensive upper limb motor impairment. As a result, they are not eligible for functional reconstructive surgery aimed at restoring elbow extension, wrist extension, or finger opening and closing. Such surgical procedures are generally reserved for individuals with spinal cord injury at or below cervical level 6 (C6).

Neuroprosthetic systems based on functional electrical stimulation (technology that activates muscles using electrical impulses) experienced significant development during the 1990s and early 2000s. Their principle relies on the stimulation of key muscles located below the level of the lesion, provided that the second motor neuron (the peripheral nerve connecting the spinal cord to the muscle) remains intact. These systems enabled active control of the wrist and fingers by stimulating muscles via multiple implanted cables connected to epimysial electrodes (electrodes positioned on the surface of the muscle). However, these devices were withdrawn from the market for economic reasons, leaving many patients without access to this therapeutic option and in a situation of complete dependency on caregivers.

Even for individuals with low or intermediate tetraplegia, or incomplete lesions, life events such as accidents, secondary illnesses, or aging may lead to additional disability and increased dependence. The need to preserve energy or limit physical effort may justify, even in individuals with residual motor capacities, the use of assistive technologies for manipulation.

Assistive robotic manipulation is currently based on three main categories of devices:

Wheelchair-mounted robotic arms Robotic arms mounted on mobile platforms Single-task robotic devices

These systems aim to enable users to perform manipulation tasks either autonomously (full control by the user) or semi-autonomously (selection of pre-programmed tasks). This applies regardless of whether the task is performed within the user's immediate environment or at a distance, and regardless of the interaction modality.

Among these technologies, wheelchair-mounted robotic arms have benefited the most from technological advances over the past 15 years and from more advanced industrial development compared to other robotic devices. Their development is based on two key principles: first, to provide a single robotic solution capable of replacing multiple assistive devices and human assistance; and second, to allow users to carry a substitute for their impaired upper limb (i.e., the robotic arm) into environments that are not specifically adapted.

Historically, the MANUS robotic arm was one of the leading systems in this field. Developed and marketed in the 1990s by a Dutch company, it demonstrated the feasibility of integrating robotics into the functional environment of users and caregivers. Public health authorities supported its deployment by equipping residential facilities and providing shared maintenance services, thereby contributing to the development of an assistive robotics ecosystem.

The MANUS system, now called the I-ARM, is a robotic arm with six degrees of freedom (independent axes of movement allowing three-dimensional motion) and a two-finger gripper. It can be mounted on a wheelchair seat or armrest. Despite improvements in weight, its control interface remains based on step-by-step commands, which are not intuitive and are relatively difficult to use. Control typically relies on a keypad or a two-dimensional joystick for three-dimensional movements. Pre-programmed menus allow more targeted control of the robotic arm.

More recently, the JACO robotic arm, developed by a Canadian company, has emerged as one of the most promising systems in terms of functional benefit and ergonomics. It introduces several technological improvements:

Use of lightweight materials such as carbon fiber Open and customizable control interface adapted to user needs Integration into the powered wheelchair control system Compatibility with environmental control systems (systems that allow users to interact with their surroundings, such as controlling devices in their home) Extended reach (approximately 90 cm) and six degrees of freedom

These features allow users to access objects located on the ground, directly in front of them, or above head level. However, effective use still requires significant user involvement in spatial positioning and grasping strategies. The availability of configuration software allows adaptation of the control interface to the user's motor impairment and the use of graphical interfaces to facilitate arm movement.

Other robotic arms remain confined to research laboratories, either because they have not been developed for commercialization or because they fail to meet ergonomic and functional requirements. These devices are often heavy, bulky, noisy, or impractical, despite their promising technical capabilities.

Published studies consistently highlight the needs of individuals with tetraplegia in terms of assistive technologies. However, no prospective study has evaluated the long-term use of robotic arms in the home environment. Limited evidence suggests improvements in functional independence, quality of life, and reduction in caregiver assistance.

The priority daily activities identified by users include:

Eating and drinking (grasping food, bringing it to the mouth, cutting food, opening containers) Personal hygiene and facial care Dressing and undressing Reaching, grasping, manipulating, and releasing everyday objects located at different heights

Despite these expectations, it is essential that users remain in control of robotic devices and retain decision-making authority. The usability of such technologies is also closely linked to the existence of a structured ecosystem capable of managing the entire process, including design, acquisition, follow-up, and maintenance. Currently, such an ecosystem remains insufficiently developed, which limits user confidence and adoption.

Successful adoption requires independent evaluation of usability and perceived usefulness in real-life or near-real-life environments. In addition, access to these technologies must be supported by appropriate funding mechanisms, and maintenance services must be reliable and responsive. Technical failure of such devices may result in immediate loss of independence for essential daily activities.

The development and implementation of assistive robotic technologies must also consider ethical principles, including functional benefit, quality of life, equitable access, user information, consideration of individual needs and expectations, respect for user preferences, and cost-effectiveness.

Previous findings suggest that the use of the JACO robotic arm may significantly reduce caregiver intervention time, potentially by approximately 41%, corresponding to about 1.5 hours per day.

The present study aims to evaluate the use of the JACO robotic arm in the home environment, focusing on its real-life use, its integration into daily activities, and its impact on functional independence, as well as psychological, social, and family well-being.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Perpignan, France, 66962
    • Centre Bouffard Vercelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JACO robotic arm	Device: Use of the JACO robotic arm for a period of 2 months; Initial evaluation of the participant.; Presentation of the device and training of the participant in the use of the JACO arm.; Autonomous use of the JACO robotic arm for a 2-month period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The administration of the COPM is carried out in three steps: Identification of problems: Formulation of the specific grasp-related tasks that the participant is unable to perform satisfactorily before using the device. Rating of these problems: For each identified problem, the participant rates the importance assigned to it on a scale from 1 to 10 (1 = "not important" and 10 = "extremely important"). Participant's evaluation of their ability to perform the problematic activities, first in terms of performance, then in terms of satisfaction with the performance. These ratings are made on scales from 1 to 10; 1 representing "unable to perform the activity" and "not satisfied at all", and 10 "able to perform the activity perfectly" and "extremely satisfied". For each participant, an average satisfaction score and an average performance score is obtained. At re-evaluation, only the associated performance and satisfaction scores are rated again.	Baseline : Between Day -15 and Day -10 ; Usage phase : Day 0; Day +30 and Day +60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial Impact of Assistive Devices Scale: F-PIADS (Day & Jutai, 1996) in its Canadian French version.	This is a 26-item questionnaire that measures the impact on quality of life (psychosocial effects) of using a functional assistive device from the perspective of the person with a disability, with 3 evaluated concepts: Competence (12 items): measures the sense of competence and effectiveness. Adaptability (6 items): measures the willingness to take risks and try new things. Self-esteem (8 items): measures emotional well-being, sense of control, and self-confidence. A sample scoring sheet is provided in the appendix of this document. During administration, the respondent rates each item on a 7-point Likert scale ranging from -3 ("maximum negative impact") to +3 ("maximum positive impact"). The score 0 indicates "no impact." The final score is the mean score obtained by adding the scores of all items and dividing the sum by 26. The sub-scores are calculated by adding the scores of the items associated with each sub-score and dividing by the number of items corresponding to that sub-sc	Day 0, Day 60 and Day 75
Self-Esteem Scale, translated by Vallières & Vallerand 1990	10 items rated from 1 to 4. The total score therefore ranges from 10 to 40. The interpretation of the results is identical for men and women : score below 25: very low self-esteem; score between 25 and 31: low self-esteem; score between 31 and 34: average self-esteem; score between 34 and 39: high self-esteem; score above 39: very high self-esteem	Day 0, Day 60 and Day 75
Satisfaction scale regarding assistive technology: The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)	This questionnaire is composed of 12 items. Eight items measure the degree of satisfaction with the technology (weight, durability, adjustability, ease of use, dimensions, effectiveness, safety). The remaining four items measure the degree of satisfaction with the related services (delivery procedure, professional services, follow-up, repair and maintenance). The items are rated on a 5-level ordinal scale ranging from 1 = "not satisfied at all" to 5 = "very satisfied." The total score is obtained by calculating the average of the points from the 12 questions. The questionnaire will be completed as a self-administered questionnaire: at Day 0 before using the system at Day 0 + 60 days, after 2 months of system use Additionally, the questionnaire is also given to the informal caregiver to assess their satisfaction at Day 0 and Day 0 + 60 days.	Day 0 and Day 60
Abandonment rate of the assistive device	The abandonment rate of the assistive device will be measured, as well as the time at which it occurred and the associated reasons.	From Day 1 to Day 60, Throughout the device use period
Intermediate Canadian Occupational Performance Measure (COPM) assessment carried out at Day 0 + 30 days of system use.	To monitor the evolution of the primary outcome, we will use, as a secondary outcome, a transition index to measure the perceived change in the problems prioritized by the COPM. The perceived change in the problems will be classified on a 7-point ordinal scale, where 1 = "completely improved," 2 = "improved," 3 = "slightly improved," 4 = "unchanged," 5 = "slightly worse," 6 = "worse," and 7 = "much worse." Improvement will be defined as a rating of completely improved, improved, or slightly improved for at least 3 of the five problems.	Day 30

Collaborators and Investigators

• Sponsor: Association APPROCHE
• Collaborators: Centre Bouffard Vercelli - USSAP; CEREMH, Avenue de l'Europe, Vélizy-Villacoublay, France

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: professional caregiver; powered wheelchair; bras robotisé d'assistance; desire for autonomy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Wounds and Injuries; Neuromuscular Diseases; Genetic Diseases, Inborn; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Trauma, Nervous System; Muscular Disorders, Atrophic; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Paralysis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Multiple Sclerosis; Muscular Dystrophies; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: 2021-A02354-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No