Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT05457166
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2022-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the KASPARD System for Fall Prevention in Nursing Homes
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Interest in Using the KASPARD System for the Prevention of Falls in Nursing Homes (EHPAD, for Its French Acronym)
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KASPARD
Brief Summary:
Falls are a frequent cause of admission to nursing homes \[2\]. It is also the most frequently reported adverse event in these institutions.
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 To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A03210-41 | OTHER | ID-RCB number, ANSM | View |