Neurological Disorder
Conditions
Brief summary
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
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.
Interventions
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
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
Sponsors
INSA Rennes
Pôle Saint Hélier
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of collision | Day 1 | The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Driving Speed | Day 1, Day 8 and Day 15 | Speed measured by the completion time of the course with and without activation of the assistance system on the different circuits |
| Wheelchair Skill Test | Day 1, Day 8 and Day 15 | Driving performance measured by the Wheelchair Skill Test items corresponding to the different courses, with and without activation of the assistance system |
| NASA-Task Load Index | Day 1, Day 8 and Day 15 | 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) |
| Ease of Use Questionnaire | Day 1, Day 8 and Day 15 | 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). |
| UTAUT (Unified theory of acceptance of technology) questionnaire | Day 1, Day 8 and Day 15 | Questionnaire of acceptability / acceptance of the tool and its use by patients based on the Unified Theory of Acceptance and Use Technology (UTAUT). |
Countries
France
Outcome results
None listed