Accidental FallsFDR-HPCNCT06493201
Research Into Risk Factors for Hospitalization Following a Fall in Older Patients
An observational study of Accidental Falls, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Every year, a considerable number of older people fall, with a variety of consequences. These falls can lead to hospitalization, with consequent adverse effects on these people, as well as a significant cost to society. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2024to 8 Mar 2025
- Phase
- Observational
- 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
- Older adult
Study population: Patient over 65 years old having had at least one fall and able to walk without human assistance
Who may be able to join
- Patient over 65 years old
- Patient having had at least one fall
- Patient able to walk without human assistance
- Hospitalized at the geriatrics center or seen in fall consultation at the Strasbourg University Hospital during the period from 05/01/2023 to 01/31/2024
Who cannot join
- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Gériatrie Aigue - CHU de Strasbourg - France
Strasbourg, 67091
Elise SCHMITT, MD, 33 3 88 12 74 47, elise.schmitt@chru-strasbourg.fr
Elise SCHMITT, MD
About this study
Every year, a considerable number of older people fall, with a variety of consequences. These falls can lead to hospitalization, with consequent adverse effects on these people, as well as a significant cost to society. The risk factors for falls themselves are well identified, but not those that lead to hospitalizations in older people who all fall. Some risk factors, such as age, cannot be modified. With a view to preventing hospitalizations in older patients who fall, The investigators aimed to identify functional, and therefore modifiable, risk factors for hospitalizations in patients who fall, such as gait parameters. The investigators hope that the results of this study will lead to early identification of the risk of hospitalization in these patients and thus to appropriate rehabilitation as early as possible to limit this risk.
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, Older adults, Gait Analysis, Hospitalization, Rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters assessed using the GAITrite® mat
The recorded GAITrite® data consisted of:
- gait speed : in (cm/s)
- cadence: in (steps/min)
- step time and cycle time : in (s)
- step length and stride length : in (cm)
Measured: The outcome measure is assessed at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start8 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completion8 Mar 2025 (estimated)
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, Strasbourg, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493201
- Sponsor's protocol ID
- 9242
- Acronym
- FDR-HPC
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 9 Jul 2024
- 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Into Risk Factors for Hospitalization Following a Fall in Older Patients
- ClinicalTrials.gov ID
- NCT06493201
- Acronym / sponsor ID
- FDR-HPC / 9242
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, Older adults, Gait Analysis, Hospitalization, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- 8 Mar 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
Every year, a considerable number of older people fall, with a variety of consequences. These falls can lead to hospitalization, with consequent adverse effects on these people, as well as a significant cost to society. The risk factors for falls themselves are well identified, but not those that lead to hospitalizations in older people who all fall. Some risk factors, such as age, cannot be modified. With a view to preventing hospitalizations in older patients who fall, The investigators aimed to identify functional, and therefore modifiable, risk factors for hospitalizations in patients who fall, such as gait parameters. The investigators hope that the results of this study will lead to early identification of the risk of hospitalization in these patients and thus to appropriate rehabilitation as early as possible to limit this risk.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patient over 65 years old having had at least one fall and able to walk without human assistance
Key inclusion criteria (4 listed)
- Patient over 65 years old
- Patient having had at least one fall
- Patient able to walk without human assistance
- Hospitalized at the geriatrics center or seen in fall consultation at the Strasbourg University Hospital during the period from 05/01/2023 to 01/31/2024
Key exclusion criteria (1 listed)
- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait parameters assessed using the GAITrite® mat
Time frame: The outcome measure is assessed at inclusion
The recorded GAITrite® data consisted of: * gait speed : in (cm/s) * cadence: in (steps/min) * step time and cycle time : in (s) * step length and stride length : in (cm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls, run by University Hospital, Strasbourg, France 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise SCHMITT, MD (33 3 88 12 74 47, elise.schmitt@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameters assessed using the GAITrite® mat (time frame: The outcome measure is assessed at inclusion). 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 9 Jul 2024.