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

Elderly Clinical Trial

— SWADAPT4  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05378828
• Other study ID #: 2021-A03138-33
• Status: Terminated
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: August 26, 2022

Study information

• Verified date: August 2023
• Source: Pôle Saint Hélier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly

Intervention

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.

Locations

Country	Name	City	State
France	Pôle Saint-Hélier	Rennes	Bretagne
France	CCAS Saint-Etienne	Saint Etienne
France	USLD Saint Etienne	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Pôle Saint Hélier	Centre Communal d'Action Sociale Saint-Etienne, Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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