Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving 1 (SWADAPT1)
Ocena znormalizowanych obwodów zainteresowania modułu robota wspomagającego prowadzenie pacjentów z zaburzeniami neurologicznymi, zwykłych kierowców wózków inwalidzkich z napędem elektrycznym.
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Brittany Region
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Rennes, Brittany Region, Francja, 35000
- Pôle Saint-Hélier
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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 |
|
Inny: 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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of collision
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Driving Speed
Ramy czasowe: 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
|
|
Wheelchair Skill Test
Ramy czasowe: 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
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NASA-Task Load Index
Ramy czasowe: 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
|
|
Ease of Use Questionnaire
Ramy czasowe: 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
Ramy czasowe: Day 1, Day 8 and Day 15
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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
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Philippe Gallien, Doctor, Pôle Saint Hélier
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2019-A00476-51
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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