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

NCT05378828 | Terminated

• 1 other identifier: 2021-A03138-33
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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.

Conditions

Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Driving habilities

  Day 42 and Day 63

• Distance traveled measured by sensors on the FRE

  Day 21, Day 42 and Day 63

• Mesure of mental load related to wheelchair mobility

  Day 21, Day 42 and Day 63

• Ease of Use Questionnaire

  Day 42

• Acceptability of anti-collision sensors by users

  Day 42

Study Arms (1)

Use of an electric wheelchair with or without sensors

OTHER

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; Other: Use of an electric wheelchair without sensors

Interventions

Using anti-collision Sensors on electric wheelchairs DEVICE

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

Use of an electric wheelchair with or without sensors

Use of an electric wheelchair without sensors OTHER

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.

Use of an electric wheelchair with or without sensors

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Impaired comprehension preventing the protocol from being carried out,
• Person in an emergency situation unable to give prior consent

Sponsors & Collaborators

• Pôle Saint Hélier: lead
• Centre Hospitalier Universitaire de Saint Etienne: collaborator
• Centre Communal d'Action Sociale Saint-Etienne: collaborator

Study Sites (3)

Pôle Saint-Hélier

Rennes, Brittany Region, 35000, France

Location

CCAS Saint-Etienne

Saint-Etienne, 42000, France

Location

USLD Saint Etienne

Saint-Etienne, 42055, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 18, 2022
• Study Start: July 21, 2022
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

FR (3)