An interventional study of Electric wheelchair with activated assistance module and Electric wheelchair with assistance module not activated in Neurological Disorder, sponsored by Pôle Saint Hélier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Pôle Saint Hélier · Not applicable, Interventional, and Prevention
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, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.
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 robotic assistance module is program to detect positive and negative obstacles.
This study "SWADAPT3" follows "SWADAPT1" and "SWADAPT2" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions:
Each patient included tested a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation was carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient performed the circuit 6 times, including 3 with activated assistance, in a random order established upstream.
974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.
This study's enrollment of 18 is below the median of 48 across 623 interventional studies indexed under Nervous System Diseases.
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Exclusion Criteria:
This condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance, in a random order established upstream.
Device: Electric wheelchair with activated assistance module
This condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activated assistance, in a random order established upstream.
Device: Electric wheelchair with assistance module not activated
This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance.
This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activating assistance.
Success rate
Pass rate across standard platforms. The platform has been divided into sectors. The crossing of the platform stops as soon as a failure occurs (swing or collision). The circuit is composed of 9 platforms divided into 91 sectors. At the end, the success rate corresponds to the numbers of sector past with success with and without activation of the assistance system. Score rate : 0-91
Time frame: Day 1
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), with and without activation of the assistance system.
Time frame: Day 1
Calculated task load Index
During the evaluation, physiological signals (cardiac frequency /electroencephalography/Electro dermal activity) will be measured by skin sensors. The signals will be used to calculate a task load Index. The score ranges between 0 and 5 with 5 being the most demanding. The score will be measured before and after each condition.
Time frame: Day 1
Spontaneous stress assessment
The spontaneous stress measured by Visual Analogic Scale, from 0 to 100. The 0 represents not stressed at all and 100 extremely stressed. The score will be measured before and after each condition.
Time frame: Day 1
Calculated Stress Index
During the evaluation, physiological signals (cardiac frequency /electroencephalography/Electro dermal activity) will be measured by skin sensors. The signals will be used to calculate a Stress Index. The score ranges between 0 and 100 with 100 being the most stressful. The score will be measured before and after each condition.
Time frame: Day 1
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 28-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). The score will be measured after each condition.
Time frame: Day 1
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). The score will be measured at the end of the evaluation.
Time frame: Day 1
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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