Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall. A Brief Intervention Focusing on Patient Reported Outcomes

Conditions
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Fear of Falling

Intervention / Treatment
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* Other: physiotherapeutic intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>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. | Other: physiotherapeutic intervention<br>* 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.<br>|
| No Intervention: control group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 and Day 7 ± 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency department (ED) length of stay (hours) | Emergency department (ED) length of stay (hours) | At Day 0 | 
| Change in Hospital Anxiety and Depression Scale (HADS) | The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. | At Day 0 and Day 42 ± 3 days | 
| Change in Pain Numeric Rating Scale (NRS) | The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain ('0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine)) | At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 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. | At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fall, Ground Level Fall (GLF), physiotherapy intervention, short International Falls efficacy scale (sFES-I)