Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving

Study Overview
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Brief Summary
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The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

Detailed Description
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The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type. This study SWADAPT2 follows SWADAPT1 with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions : Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Official Title
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Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, in Difficulty Driving of Electric Wheelchairs

Conditions
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Neurological Disorder

Intervention / Treatment
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* Device: Electric wheelchair with activated assistance module
* Device: Electric wheelchair with assistance module not activated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18, Having read the information note and freely consented to participate in the study, Suffering from neurological disorders such as cerebro-lesion or neuro-degeneration, Having benefited from an electric wheelchair prescription or learning to drive. Having difficulties driving an electric wheelchair impacting their indoor and/or outdoor driving safety, as shown by the WST score. The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module. Exclusion Criteria: Understanding difficulties preventing the realization of the protocol, Motor disorders of the upper limb requiring additional driving technical assistance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric wheelchair with activated assistance module<br>This condition will be achieved in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream. | Device: Electric wheelchair with activated assistance module<br>* This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance<br>|
| Other: Electric wheelchair with assistance module not activated<br>This condition will be achieved in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 without activated assistance, in a random order established upstream. | Device: Electric wheelchair with assistance module not activated<br>* This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with no activated assistance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of collision | The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. | Day 1 | 
| Number of collision | The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. | Day 8 | 
| Number of collision | The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving Speed | Speed measured by the completion time of the course with and without activation of the assistance system on the different circuits | Day 1, Day 8 and Day 15 | 
| Wheelchair Skill Test | Driving performance measured by the Wheelchair Skill Test items corresponding to the different courses, with and without activation of the assistance system | Day 1, Day 8 and Day 15 | 
| NASA-Task Load Index | The cognitive load of tests under both conditions will be measured by the NASA-Task Load Index. It is in the form of six scales where the participant must assign a score between zero and one hundred to each of them, score indicating a growing level of intensity. Three dimensions relate to the demands imposed on the subject (mental, physical and temporal demands) and three to the interaction of a subject with the task (effort, frustration and performance) | Day 1, Day 8 and Day 15 | 
| Ease of Use Questionnaire | The satisfaction of the use of the electric wheelchair under the conditions will be evaluated by the self-questionnaire Ease of Use Questionnaire. It measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. The questionnaires were constructed as seven-point Likert rating scales. Users were asked to rate agreement with the statements, ranging from strongly disagree (1) to strongly agree (7). | Day 1, Day 8 and Day 15 | 
| UTAUT (Unified theory of acceptance of technology) questionnaire | Questionnaire of acceptability / acceptance of the tool and its use by patients based on the Unified Theory of Acceptance and Use Technology (UTAUT). | Day 1, Day 8 and Day 15 |