Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors for Elderly People in EHPAD

Study Overview
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Brief Summary
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The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.

Official Title
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Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors to Improve the Driving Confidence of Elderly People in EHPAD

Conditions
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Elderly

Intervention / Treatment
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* Device: Using anti-collision Sensors on electric wheelchairs
* Other: Use of an electric wheelchair without sensors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 60 years of age, Resident in an institution for the elderly or nursing home, with a electric wheelchair but expressing driving difficulties Having freely consented to participate in the study, In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and having given his or her free and informed consent for the person for whom he or she is responsible to participate in the study (in agreement with the patient). Exclusion Criteria: Impaired comprehension preventing the protocol from being carried out, Person in an emergency situation unable to give prior consent

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Use of an electric wheelchair with or without sensors<br>During 3 weeks, the electric weehlchair will not have sensors, then sensors will be put on the wheelchair for the next 3 weeks then removed for 3 other weeks. | Device: Using anti-collision Sensors on electric wheelchairs<br>* use of anti-collision sensors on the electric wheelchair during 3 weeks<br>Other: Use of an electric wheelchair without sensors<br>* Use of an electric wheelchair without sensors for 3 weeks before using anti-collision sensors then during 3 weeks after using the anti-collision sensors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD | Evaluation by using the under score of confidence of Wheelchair Skill Test questionnaire (WST-Q-T 5.1) during the period of use of the module and at the end. The score goes from 0 to 56 (56 is the higher level of confidence). | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving habilities | Benefits of the sensors on ability and performance of tasks performed with the electric wheelchair by Wheelchair Skill Test questionnaire (WST-Q-T 5.1). The score will go from 0 to 56 for each scale (performance and frequency), a high score will represent a good driving performance | Day 42 and Day 63 | 
| Distance traveled measured by sensors on the FRE | The distance will be measured in meters with a lap counter type. | Day 21, Day 42 and Day 63 | 
| Mesure of mental load related to wheelchair mobility | Mental load 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 21, Day 42 and Day 63 | 
| Ease of Use Questionnaire | Satisfaction of using FRE by users will be mesured by the Ease of Use Questionnaire. He is composed of 27 questions, each question is valued between 0 to 7. a high score will represent a high satisfaction. | Day 42 | 
| Acceptability of anti-collision sensors by users | A acceptability questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) will be completed at day 42, with semi-directive interview | Day 42 |