Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving 1 (SWADAPT1)
Evaluatie van gestandaardiseerde circuits van het belang van een robotmodule ter ondersteuning van het besturen van patiënten met neurologische aandoeningen, reguliere bestuurders van elektrische rolstoelen.
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Brittany Region
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Rennes, Brittany Region, Frankrijk, 35000
- Pôle Saint-Hélier
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Aged over 18,
- Having freely consented to participate in the study,
- suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
- Having benefited from a prescription of electric wheelchair and circulating in an electric wheelchair for more than 3 months,
- of which the electric wheelchair is the main mode of transport,
- 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,
- Patient having expressed difficulties impacting his safety of sedan and / or exterior.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
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 |
|
Ander: 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. |
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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of collision
Tijdsspanne: Day 1
|
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. |
Day 1
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Number of collision
Tijdsspanne: Day 8
|
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
Tijdsspanne: Day 15
|
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. |
Day 15
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Driving Speed
Tijdsspanne: 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 |
Day 1, Day 8 and Day 15
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Wheelchair Skill Test
Tijdsspanne: 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 |
Day 1, Day 8 and Day 15
|
|
NASA-Task Load Index
Tijdsspanne: 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) |
Day 1, Day 8 and Day 15
|
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Ease of Use Questionnaire
Tijdsspanne: 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). |
Day 1, Day 8 and Day 15
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UTAUT (Unified theory of acceptance of technology) questionnaire
Tijdsspanne: 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). |
Day 1, Day 8 and Day 15
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Philippe Gallien, Doctor, Pôle Saint Hélier
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2019-A00476-51
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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