Study of Home Use of the Jaco Robotic Manipulation Device by Individuals With Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
时间窗: Baseline : Between Day -15 and Day -10 ; Usage phase : Day 0; Day +30 and Day +60
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.
次要结局
- Self-Esteem Scale, translated by Vallières & Vallerand 1990(Day 0, Day 60 and Day 75)
- Psychosocial Impact of Assistive Devices Scale: F-PIADS (Day & Jutai, 1996) in its Canadian French version.(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)