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

NCT07680361 | Completed

• 1 other identifier: 2021-A02354-37
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tetraplegia; Functional Tetraplegia; Spinal Cord Injury; Muscular Dystrophy; ALS (Amyotrophic Lateral Sclerosis); Multiple Sclerosis

Keywords

powered wheelchair; bras robotisé d'assistance; desire for autonomy; professional caregiver

Outcome Measures

Primary Outcomes (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)

  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 Outcomes (5)

• Psychosocial Impact of Assistive Devices Scale: F-PIADS (Day & Jutai, 1996) in its Canadian French version.

  Day 0, Day 60 and Day 75

• Self-Esteem Scale, translated by Vallières & Vallerand 1990

  Day 0, Day 60 and Day 75

• Satisfaction scale regarding assistive technology: The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)

  Day 0 and Day 60

• Abandonment rate of the assistive device

  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.

  Day 30

Study Arms (1)

JACO robotic arm

EXPERIMENTAL

Device: Use of the JACO robotic arm for a period of 2 months

Interventions

Use of the JACO robotic arm for a period of 2 months DEVICE

1. Initial evaluation of the participant. 2. Presentation of the device and training of the participant in the use of the JACO arm. 3. Autonomous use of the JACO robotic arm for a 2-month period

JACO robotic arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Association APPROCHE: lead
• Centre Bouffard Vercelli - USSAP: collaborator
• CEREMH, Avenue de l'Europe, Vélizy-Villacoublay, France: collaborator

Study Sites (1)

Centre Bouffard Vercelli

Perpignan, 66962, France

Location

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries; Muscular Dystrophies; Amyotrophic Lateral Sclerosis; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Use of the JACO robotic arm for 2 months

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: July 2, 2026
• Study Start: March 30, 2022
• Primary Completion: March 30, 2022
• Study Completion: April 21, 2023
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

FR (1)