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

Fear of Falling Clinical Trial

— EPAC-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05156944
• Other study ID #: 2021-02165; am21Bingisser2
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Emergencies
• Fear of Falling

Intervention

Other:
• physiotherapeutic intervention
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.

Locations

Country	Name	City	State
Switzerland	Department of Emergency Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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