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Clinical Trials/NCT05378828
NCT05378828
Terminated
Not Applicable

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

Pôle Saint Hélier3 sites in 1 country1 target enrollmentJuly 21, 2022
ConditionsElderly

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly
Sponsor
Pôle Saint Hélier
Enrollment
1
Locations
3
Primary Endpoint
Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2022
End Date
August 26, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Pôle Saint Hélier
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD

Time Frame: 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 Outcomes

  • Distance traveled measured by sensors on the FRE(Day 21, Day 42 and Day 63)
  • Driving habilities(Day 42 and Day 63)
  • Acceptability of anti-collision sensors by users(Day 42)
  • Mesure of mental load related to wheelchair mobility(Day 21, Day 42 and Day 63)
  • Ease of Use Questionnaire(Day 42)

Study Sites (3)

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