EmergenciesKiUrgeNCT05753319
Physiotherapist in the Emergency Department
An observational study of Emergencies and Fall, run by Nantes University Hospital at 1 site in France.
Trial summary
This study aims to evaluate the impact of assessment and early physiotherapy management on the care pathway of the elderly person who falls, their length of stay in hospital and their fall recurrence rate. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Emergencies, Fall
- What is being tested?
- Physiotherapy in the emergency department after a fall
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2023to 14 Mar 2024
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: People aged 75 and over admitted to emergency for falls
Who may be able to join
- Patients aged 75 and over
- Patients admitted to emergency for falls.
- Clinically stable patient who may benefit from a gait assessment or fall risk assessment
- Patients able to understand the protocol and not verbally object to participation.
Who cannot join
- Patients with limb fractures requiring surgical treatment
- Patients under guardianship or curatorship.
- Patients already included in an interventional research protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapist in the Emergency Department : What Impact Does the Intervention of the Physiotherapist Have on the Care Pathway of the Elderly Person Who Falls?
This study aims to evaluate the impact of assessment and early physiotherapy management on the care pathway of the elderly person who falls, their length of stay in hospital and their fall recurrence rate.
- Conditions
- Emergencies, Fall
- Being tested
- Physiotherapy in the emergency department after a fall
- Keywords
- Emergency department, Elderly person, Physiotherapist, Fall
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy in the emergency department after a fallOther
Realization of a physiotherapy assessment.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group | Intervention group with assessment and early physiotherapy Receives: Other: Physiotherapy in the emergency department after a fall | |
| Control group | control group without assessment and physiotherapy in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient orientation (return home, short-term hospitalization unit, hospitalization) at discharge from the emergency department
The orientation of the patient on discharge from the emergency services, according to the three defined pathways (return home, short-term hospitalization unit, hospitalization).
Measured: up to 48 hours
Secondary outcomes (5)
Length of stay in emergency departments and in the short stay hospital unit
Calculation of the duration in hours by recording the dates and times of admission and discharge from the service.
Measured: up to 48 hours
Total duration of hospitalization for each stay, all services combined
Calculation of the duration in hours by recording the dates and times of admission to the emergency services and final discharge from the hospital.
Measured: 1 week
Number of recurrence of emergency admission for the same reason (fall)
Recurrence of a fall within seven days of returning home
Measured: up to 9 days
Satisfaction of doctors in emergency services
A satisfaction questionnaire will be sent to all doctors who participated in the study
Measured: 0 day
Emergency discharge referral before and after assessment by the physical therapist.
For the "Physiotherapy group" : Description of changes in physician orientation decision (return home, acute care unit, hospitalization) of patients, before/after the physical therapist assessment
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start6 Apr 2023
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Motricité, Interactions, Performance (UR 4334) of Nantes University
- Responsible party
- Sponsor
- Investigators
- Marie Blandin, Principal investigator, Nantes University HospitalMarie Gallet, Principal investigator, marie.gallet@chu-nantes.frGuillaume LE SANT, PhD, Principal investigator, Laboratoire Motricité, Interactions, Performance (UR 4334)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753319
- Sponsor's protocol ID
- RC23_0068
- Acronym
- KiUrge
- Status last verified
- May 2024
- First submitted
- 10 Feb 2023
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Blandin M, Gallet M, Volteau C, Le Conte P, Rulleau T, Le Sant G. Effects of the delivery of physiotherapy on the treatment course of elderly fallers presenting to the emergency department: Protocol for a randomized clinical trial. PLoS One. 2024 May 8;19(5):e0303362. doi: 10.1371/journal.pone.0303362. eCollection 2024.
PubMed 38718002
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapist in the Emergency Department : What Impact Does the Intervention of the Physiotherapist Have on the Care Pathway of the Elderly Person Who Falls?
- ClinicalTrials.gov ID
- NCT05753319
- Acronym / sponsor ID
- KiUrge / RC23_0068
- Conditions
- Emergencies, Fall
- Keywords
- Emergency department, Elderly person, Physiotherapist, Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Laboratoire Motricité, Interactions, Performance (UR 4334) of Nantes University
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 3 Mar 2023 (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.
This study aims to evaluate the impact of assessment and early physiotherapy management on the care pathway of the elderly person who falls, their length of stay in hospital and their fall recurrence rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy group | – | Other: Physiotherapy in the emergency department after a fallIntervention group with assessment and early physiotherapy |
| Control group | – | –control group without assessment and physiotherapy in the emergency department |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- People aged 75 and over admitted to emergency for falls
Key inclusion criteria (4 listed)
- Patients aged 75 and over
- Patients admitted to emergency for falls.
- Clinically stable patient who may benefit from a gait assessment or fall risk assessment
- Patients able to understand the protocol and not verbally object to participation.
Key exclusion criteria (3 listed)
- Patients with limb fractures requiring surgical treatment
- Patients under guardianship or curatorship.
- Patients already included in an interventional research protocol.
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 |
|---|---|---|
| Physiotherapy in the emergency department after a fallRealization of a physiotherapy assessment. | Other | Physiotherapy group |
Primary outcome
Patient orientation (return home, short-term hospitalization unit, hospitalization) at discharge from the emergency department
Time frame: up to 48 hours
The orientation of the patient on discharge from the emergency services, according to the three defined pathways (return home, short-term hospitalization unit, hospitalization).
5 secondary outcomes
Length of stay in emergency departments and in the short stay hospital unit
Time frame: up to 48 hours
Total duration of hospitalization for each stay, all services combined
Time frame: 1 week
Number of recurrence of emergency admission for the same reason (fall)
Time frame: up to 9 days
Satisfaction of doctors in emergency services
Time frame: 0 day
Emergency discharge referral before and after assessment by the physical therapist.
Time frame: up to 48 hours
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 22 May 2024.
- Derived from this study: PubMed 38718002Blandin M, Gallet M, Volteau C, Le Conte P, Rulleau T, Le Sant G. Effects of the delivery of physiotherapy on the treatment course of elderly fallers presenting to the emergency department: Protocol for a randomized clinical trial. PLoS One. 2024 May 8;19(5):e0303362. doi: 10.1371/journal.pone.0303362. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
Marie Blandin principal investigator
Nantes University Hospital
Marie Gallet principal investigator
marie.gallet@chu-nantes.fr
Guillaume LE SANT, PhD principal investigator
Laboratoire Motricité, Interactions, Performance (UR 4334)
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 Emergencies and Fall, run by Nantes University Hospital 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 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 22 May 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?
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?
Patient orientation (return home, short-term hospitalization unit, hospitalization) at discharge from the emergency department (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753319, which also lists 1 linked publication.
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 22 May 2024.