Fear of Falling Clinical Trial
— EPAC-IOfficial title:
Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall. A Brief Intervention Focusing on Patient Reported Outcomes
Verified date | April 2024 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | August 11, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Written informed consent - Age =65 - History of falls within the last 7 days - Presentation to the ED of the University Hospital Basel Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Emergency Medicine, University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At Day 0 and Day 7 ± 7 days | |
Secondary | Feasibility of the intervention | Feasibility of the intervention assessed by a questionnaire filled out by the physiotherapist | At Day 0 | |
Secondary | Objective functional levels in the intervention group | Functional levels measured by SPPB in the intervention group | At Day 0 and Day 7 ± 7 days | |
Secondary | Satisfaction with ED work-up | Patients' satisfaction with ED work-up assessed by questionnaire | Day 7 ± 7 days | |
Secondary | 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. | At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days | |
Secondary | Utilization of medical resources | Comparison of the use of medical resources between both groups (ED visits, GP visits, hospitalization, physiotherapy, imaging; all since inclusion) | Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days | |
Secondary | Occurence of falls | Occurence of falls following randomization from patient recollection | Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days |
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