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| Name | Class |
|---|---|
| INSA Rennes | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric wheelchair with activated assistance module | Experimental | 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. |
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| Electric wheelchair with assistance module not activated | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric wheelchair with activated assistance module | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Gallien, Doctor | Pôle Saint Hélier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle Saint-Hélier | Rennes | Brittany Region | 35000 | France |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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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.
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To minimize bias, this study will be randomized and conducted in single blind. The patient will not be aware of the activation or not of the assistance module placed on the electric wheelchair. Indeed, the investigative team will be in charge of the activation of the robotic module.
| Electric wheelchair with assistance module not activated | Device | 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 |
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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 |