Accidental FallsKASPARDNCT05457166
Use of the KASPARD System for Fall Prevention in Nursing Homes
A study testing KASPARD system for fall prevention in nursing homes in people with Accidental Falls and Nursing Homes, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls, Nursing Homes
- What is being tested?
- KASPARD system for fall prevention in nursing homes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and/or female resident of an EHPAD
- 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).
Who cannot join
- Refusal to participate in the study
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest in Using the KASPARD System for the Prevention of Falls in Nursing Homes (EHPAD, for Its French Acronym)
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].
Read more
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
- Conditions
- Accidental Falls, Nursing Homes
- Being tested
- KASPARD system for fall prevention in nursing homes
- Keywords
- Elderly person, EHPAD, Fall, Prevention, Detection system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KASPARD system for fall prevention in nursing homesDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | 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 Receives: Device: KASPARD system for fall prevention in nursing homes |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of falls observed over a period of 100 nights with KASPARD
To show that the KASPARD system reduces the number of falls observed over a period of 100 nights with the device activated compared to a period of 100 nights with the device deactivated, in elderly people aged over 65 years residing in EPAD and at high risk of falling.
Measured: 100 nights
Secondary outcomes (7)
The number of night shift interventions
Measured: 100 nights with the device on versus 100 nights with the device off
The number of nights without restraint
Measured: 100 nights with the device on versus 100 nights with the device off
The time taken to intervene after a fall
Time between the occurrence of the fall and the arrival of staff at the patient's bedside
Measured: 100 nights with the device on versus 100 nights with the device off
Fear of falling assessed by the FES scale
Fear of falling reported by residents at the end of each period: last day of period 1 and last day of period 2
Measured: 100 nights with the device on versus 100 nights with the device off
Quality of life questionnaire
Quality of life questionnaire reported by the patient and once at the end of each period: last day of period 1 and last day of period 2
Measured: 100 nights with the device on versus 100 nights with the device off
Resident satisfaction
Resident satisfaction will be assessed by a satisfaction questionnaire
Measured: activation period of 100 nights
Night and day staff satisfaction
Staff satisfaction will be assessed by a satisfaction questionnaire evaluating organisational aspects, disturbance of walking patients, interest in the reports provided by the system
Measured: activation period of 100 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start7 Jul 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Puisieux, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457166
- Sponsor's protocol ID
- 2020_89
- Other IDs
- 2021-A03210-41
- Acronym
- KASPARD
- Status last verified
- May 2026
- First submitted
- 8 Jul 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in Using the KASPARD System for the Prevention of Falls in Nursing Homes (EHPAD, for Its French Acronym)
- ClinicalTrials.gov ID
- NCT05457166
- Acronym / sponsor ID
- KASPARD / 2020_89
- Conditions
- Accidental Falls, Nursing Homes
- Keywords
- Elderly person, EHPAD, Fall, Prevention, Detection system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: KASPARD system for fall prevention in nursing homespatients 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male and/or female resident of an EHPAD
- 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
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KASPARD system for fall prevention in nursing homesAll 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) | Device | patients |
Primary outcome
the number of falls observed over a period of 100 nights with KASPARD
Time frame: 100 nights
To show that the KASPARD system reduces the number of falls observed over a period of 100 nights with the device activated compared to a period of 100 nights with the device deactivated, in elderly people aged over 65 years residing in EPAD and at high risk of falling.
7 secondary outcomes
The number of night shift interventions
Time frame: 100 nights with the device on versus 100 nights with the device off
The number of nights without restraint
Time frame: 100 nights with the device on versus 100 nights with the device off
The time taken to intervene after a fall
Time frame: 100 nights with the device on versus 100 nights with the device off
Fear of falling assessed by the FES scale
Time frame: 100 nights with the device on versus 100 nights with the device off
Quality of life questionnaire
Time frame: 100 nights with the device on versus 100 nights with the device off
Resident satisfaction
Time frame: activation period of 100 nights
Night and day staff satisfaction
Time frame: activation period of 100 nights
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Puisieux, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KASPARD system for fall prevention in nursing homes in people with Accidental Falls and Nursing Homes, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of falls observed over a period of 100 nights with KASPARD (time frame: 100 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.