Use of the KASPARD System for Fall Prevention in Nursing Homes
NCT ID: NCT05457166
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-07
2026-10-31
Brief Summary
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The prevention of falls in EHPAD must mobilise several levers of action and involve all staff. It must be included in the establishment's project in the same way as the policy on the proper use of restraints \[21\].
Home automation and new technologies can contribute to the prevention of falls and their consequences. Most of the existing solutions on the market are either fall detection solutions based on a watch or pendant or rise detection solutions based on a sub-mattress or floor mat. All of these solutions work with a contact and often require a daily set-up or check by the care teams. But the real challenge today for new technologies is to prevent falls in the elderly, by directly addressing the risk factors.
KASPARD is a non-contact (remote sensors) and non-intrusive (no video image, it uses point cloud technology) solution for detecting falls, excessive wandering and nocturnal activities in a nursing home. The information is transmitted securely via the wifi network to a mobile phone (or TSI/DECT) and to a computer. The KASPARD solution, which is already on the market (non-medical CE marking), is used in several EHPADs in Belgium and France. It is not a medical device. To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).
We wish to verify the effectiveness of the KASPARD technology for the prevention of falls in EHPAD, suggested for the moment by an observational study, with the help of a multi-centre clinical study
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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patients
patients in a before/after experimental design to assess the value of using the KASPARD technology compared to the conventional management of patients with falls in nursing homes
KASPARD system for fall prevention in nursing homes
All subjects will be monitored for 2 periods of 100 nights each. Recordings will be made continuously at night for the duration of the study Period 0: set-up, adjustment, recording (without alarm); This is a preparatory phase which is part of the usual use of the device.
Duration: 10 days Before period: The BEFORE period runs for 100 nights during which the device alarm is not activated, but the device records events.
After period: The AFTER period is 100 nights during which the device alarm is activated: Monitoring with recording + alarm activated (usual care + action if alarm is triggered)
Interventions
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KASPARD system for fall prevention in nursing homes
All subjects will be monitored for 2 periods of 100 nights each. Recordings will be made continuously at night for the duration of the study Period 0: set-up, adjustment, recording (without alarm); This is a preparatory phase which is part of the usual use of the device.
Duration: 10 days Before period: The BEFORE period runs for 100 nights during which the device alarm is not activated, but the device records events.
After period: The AFTER period is 100 nights during which the device alarm is activated: Monitoring with recording + alarm activated (usual care + action if alarm is triggered)
Eligibility Criteria
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Inclusion Criteria
* Person aged ≥ 65 years
* Elderly person at high risk of falling (fell at least 1 time in the 6 months prior to inclusion)
* Resident or his/her legal representative who has given free, written, informed consent to participate in the trial
* Socially insured resident
* Resident willing to comply with all study procedures and duration. The questionnaires used will be validated questionnaires for the target population (QoL-AD questionnaire for residents and their carers).
Exclusion Criteria
* Elderly resident who has a fall and for whom the use of a restraint is deemed essential by the coordinating doctor of the EHPAD
* Persons under legal protection are not excluded.
65 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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François Puisieux, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Pôle de gérontologie - Hôpital Les Bateliers
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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François PUISIEUX, Pr
Role: primary
Other Identifiers
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2021-A03210-41
Identifier Type: OTHER
Identifier Source: secondary_id
2020_89
Identifier Type: -
Identifier Source: org_study_id