Fear of FallingEPAC-INCT05156944
Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall
A study testing physiotherapeutic intervention in people with Fear of Falling, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this monocentric, block-randomized, controlled, open-label, parallel-group study is to assess whether patients presenting to the emergency department (ED) with a fall within the past 7 days would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fear of Falling
- What is being tested?
- physiotherapeutic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jan 2022to 11 Aug 2023
- 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
- Written informed consent
- Age ≥65
- History of falls within the last 7 days
- Presentation to the ED of the University Hospital Basel
Who cannot join
- Inpatient disposition after ED work-up
- Immobilizing fractures of the lower extremities
- Inability or contraindications to undergo the investigated intervention or follow the study procedures, e.g. due to certain neurological disorders (such as parkinsonism, hemiplegia, severe multiple sclerosis), language problems, psychological disorders, cognitive impairment
- Prior enrolment in this trial
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Emergency Medicine, University Hospital Basel
Basel, 4031
About this study
Official title: Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall. A Brief Intervention Focusing on Patient Reported Outcomes
The aim of this monocentric, block-randomized, controlled, open-label, parallel-group study is to assess whether patients presenting to the emergency department (ED) with a fall within the past 7 days would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at the time of ED presentation. Primary objective of this study is to assess "fear of falling" 7 days after ED presentation with versus without a physiotherapy intervention.
- Conditions
- Fear of Falling
- Being tested
- physiotherapeutic intervention
- Keywords
- fall, Ground Level Fall" (GLF), physiotherapy intervention, short International Falls efficacy scale (sFES-I)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapeutic interventionOther
The intervention consists of a brief physiotherapeutic assessment, the short physical performance battery, a brief information on the expected course of the condition, a check of fall hazards at home using the "Bundesamt für Unfallverhütung" (bfu) checklist, and instructions on self-management (eg. staying active, adaptation of behavior and surrounding at home). Additionally, two exercises for daily self-guided therapy will be instructed, namely, sit-to-stand and balance performance exercises.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The study intervention is a brief physiotherapeutic assessment, a brief information on the expected course of the condition, and a brief instruction on self-management, including two exercises for daily self-guided therapy. Receives: Other: physiotherapeutic intervention |
| control group | No intervention | The control group will receive written information on the expected course of the condition, written instructions on self-management and written instructions on exercises for daily self-guided therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in short International Falls efficacy scale (sFES-I)
Change in the fear of falling between groups at day 7, measured by the short International Falls efficacy scale (sFES-I). It is a 7-item questionnaire where individuals are instructed to score their concern of falling during an activity on a 4 point Likert scale with 1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total, with a higher score indicating a higher fear of falling.
Measured: At Day 0 and Day 7 ± 7 days
Secondary outcomes (6)
Feasibility of the intervention
Feasibility of the intervention assessed by a questionnaire filled out by the physiotherapist
Measured: At Day 0
Objective functional levels in the intervention group
Functional levels measured by SPPB in the intervention group
Measured: At Day 0 and Day 7 ± 7 days
Satisfaction with ED work-up
Patients' satisfaction with ED work-up assessed by questionnaire
Measured: Day 7 ± 7 days
Change in short International Falls efficacy scale (sFES-I)
Change in the fear of falling, measured by the short International Falls efficacy scale (sFES-I). It is a 16-item questionnaire where individuals are instructed to score their concern of falling during an activity on a 4 point Likert scale with 1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total, with higher the score, higher being the concern for falling.
Measured: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Utilization of medical resources
Comparison of the use of medical resources between both groups (ED visits, GP visits, hospitalization, physiotherapy, imaging; all since inclusion)
Measured: Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Occurence of falls
Occurence of falls following randomization from patient recollection
Measured: Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start6 Jan 2022
- Primary completion30 Jun 2023
- Study completion11 Aug 2023
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 Fear of FallingStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Bingisser, Prof. Dr. med., Principal investigator, Department of Emergency Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156944
- Sponsor's protocol ID
- 2021-02165; am21Bingisser2
- Acronym
- EPAC-I
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benhamou J, Espejo T, Riedel HB, Dreher-Hummel T, Garcia-Martinez A, Gubler-Gut B, Kirchberger J, Overberg JA, Perrot G, Bingisser R, Nickel CH. On-site physiotherapy in older emergency department patients following a fall: a randomized controlled trial. Eur Geriatr Med. 2025 Feb;16(1):205-217. doi: 10.1007/s41999-024-01091-x. Epub 2024 Nov 16.
PubMed 39548032
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall. A Brief Intervention Focusing on Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT05156944
- Acronym / sponsor ID
- EPAC-I / 2021-02165; am21Bingisser2
- Conditions
- Fear of Falling
- Keywords
- fall, Ground Level Fall" (GLF), physiotherapy intervention, short International Falls efficacy scale (sFES-I)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 14 Dec 2021 (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.
The aim of this monocentric, block-randomized, controlled, open-label, parallel-group study is to assess whether patients presenting to the emergency department (ED) with a fall within the past 7 days would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at the time of ED presentation. Primary objective of this study is to assess "fear of falling" 7 days after ED presentation with versus without a physiotherapy intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: physiotherapeutic interventionThe study intervention is a brief physiotherapeutic assessment, a brief information on the expected course of the condition, and a brief instruction on self-management, including two exercises for daily self-guided therapy. |
| control group | No intervention | –The control group will receive written information on the expected course of the condition, written instructions on self-management and written instructions on exercises for daily self-guided therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Age ≥65
- History of falls within the last 7 days
- Presentation to the ED of the University Hospital Basel
Key exclusion criteria (4 listed)
- Inpatient disposition after ED work-up
- Immobilizing fractures of the lower extremities
- Inability or contraindications to undergo the investigated intervention or follow the study procedures, e.g. due to certain neurological disorders (such as parkinsonism, hemiplegia, severe multiple sclerosis), language problems, psychological disorders, cognitive impairment
- Prior enrolment in this trial
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 |
|---|---|---|
| physiotherapeutic interventionThe intervention consists of a brief physiotherapeutic assessment, the short physical performance battery, a brief information on the expected course of the condition, a check of fall hazards at home using the "Bundesamt für Unfallverhütung" (bfu) checklist, and instructions on self-management (eg. staying active, adaptation of behavior and surrounding at home). Additionally, two exercises for daily self-guided therapy will be instructed, namely, sit-to-stand and balance performance exercises. | Other | intervention group |
Primary outcome
Change in short International Falls efficacy scale (sFES-I)
Time frame: At Day 0 and Day 7 ± 7 days
Change in the fear of falling between groups at day 7, measured by the short International Falls efficacy scale (sFES-I). It is a 7-item questionnaire where individuals are instructed to score their concern of falling during an activity on a 4 point Likert scale with 1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total, with a higher score indicating a higher fear of falling.
6 secondary outcomes
Feasibility of the intervention
Time frame: At Day 0
Objective functional levels in the intervention group
Time frame: At Day 0 and Day 7 ± 7 days
Satisfaction with ED work-up
Time frame: Day 7 ± 7 days
Change in short International Falls efficacy scale (sFES-I)
Time frame: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Utilization of medical resources
Time frame: Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Occurence of falls
Time frame: Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
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 Apr 2024.
- Derived from this study: PubMed 39548032Benhamou J, Espejo T, Riedel HB, Dreher-Hummel T, Garcia-Martinez A, Gubler-Gut B, Kirchberger J, Overberg JA, Perrot G, Bingisser R, Nickel CH. On-site physiotherapy in older emergency department patients following a fall: a randomized controlled trial. Eur Geriatr Med. 2025 Feb;16(1):205-217. doi: 10.1007/s41999-024-01091-x. Epub 2024 Nov 16.
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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.
Roland Bingisser, Prof. Dr. med. principal investigator
Department of Emergency Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapeutic intervention in people with Fear of Falling, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 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 Apr 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 Switzerland. 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?
Change in short International Falls efficacy scale (sFES-I) (time frame: At Day 0 and Day 7 ± 7 days). 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 NCT05156944, 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 12 Apr 2024.