Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors for Elderly People in EHPAD (SWADAPT4)

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

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.

Study Overview

• Status: Terminated
• Conditions: Elderly
• Intervention / Treatment: Device: Using anti-collision Sensors on electric wheelchairs; Other: Use of an electric wheelchair without sensors

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42000
    • CCAS Saint-Etienne
  • Saint-Étienne, France, 42055
    • USLD Saint Etienne
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Pôle Saint-Hélier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Use of an electric wheelchair with or 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.	Device: Using anti-collision Sensors on electric wheelchairs; use of anti-collision sensors on the electric wheelchair during 3 weeks; Other: Use of an electric wheelchair without sensors; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier
• Collaborators: Centre Hospitalier Universitaire de Saint Etienne; Centre Communal d'Action Sociale Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): August 26, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A03138-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No