Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving
- Conditions
- Neurological Disorder
- Interventions
- Device: Electric wheelchair with activated assistance moduleDevice: Electric wheelchair with assistance module not activated
- Registration Number
- NCT04259151
- Lead Sponsor
- Pôle Saint Hélier
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- Understanding difficulties preventing the realization of the protocol,
- Motor disorders of the upper limb requiring additional driving technical assistance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Electric wheelchair with activated assistance module Electric wheelchair with activated assistance module 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. Electric wheelchair with assistance module not activated Electric wheelchair with assistance module not activated 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.
- Primary Outcome Measures
Name Time Method Number of collision Day 15 The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Pôle Saint-Hélier
🇫🇷Rennes, Bretagne, France