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

Not Applicable

Terminated

• Conditions: Elderly
• Interventions: Device: Using anti-collision Sensors on electric wheelchairs; Other: Use of an electric wheelchair without sensors

• Registration Number: NCT05378828
• Lead Sponsor: Pôle Saint Hélier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Study Start: 2022-07-21
• Primary Completion: 2022-08-26
• Study Completion: 2022-08-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of an electric wheelchair with or without sensors	Use of an electric wheelchair without sensors	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.
Use of an electric wheelchair with or without sensors	Using anti-collision Sensors on electric wheelchairs	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.

Primary Outcome Measures

Name	Time	Method
Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD	Day 42	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).

Secondary Outcome Measures

Name	Time	Method
Distance traveled measured by sensors on the FRE	Day 21, Day 42 and Day 63	The distance will be measured in meters with a lap counter type.
Driving habilities	Day 42 and Day 63	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
Acceptability of anti-collision sensors by users	Day 42	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
Mesure of mental load related to wheelchair mobility	Day 21, Day 42 and Day 63	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).
Ease of Use Questionnaire	Day 42	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.

Trial Locations

Locations (3)

CCAS Saint-Etienne; 🇫🇷 Saint Etienne, France

USLD Saint Etienne; 🇫🇷 Saint-Étienne, France

Pôle Saint-Hélier; 🇫🇷 Rennes, Bretagne, France