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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05378828
Acronym
SWADAPT4
Enrollment
1
Registered
2022-05-18
Start date
2022-07-21
Completion date
2022-08-26
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly

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.

Interventions

DEVICEUsing anti-collision Sensors on electric wheelchairs

use of anti-collision sensors on the electric wheelchair during 3 weeks

OTHERUse 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
CollaboratorOTHER
Centre Communal d'Action Sociale Saint-Etienne
CollaboratorUNKNOWN
Pôle Saint Hélier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPADDay 42Evaluation 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

MeasureTime frameDescription
Driving habilitiesDay 42 and Day 63Benefits 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
Distance traveled measured by sensors on the FREDay 21, Day 42 and Day 63The distance will be measured in meters with a lap counter type.
Mesure of mental load related to wheelchair mobilityDay 21, Day 42 and Day 63Mental 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 QuestionnaireDay 42Satisfaction 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.
Acceptability of anti-collision sensors by usersDay 42A acceptability questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) will be completed at day 42, with semi-directive interview

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026