Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall (EPAC-I)

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.

Study Overview

• Status: Completed
• Conditions: Fear of Falling
• Intervention / Treatment: Other: physiotherapeutic intervention

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Emergency Medicine, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; 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.
Experimental: intervention group; 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; 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.

What is the study measuring?

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Feasibility of the intervention	Feasibility of the intervention assessed by a questionnaire filled out by the physiotherapist	At Day 0
Objective functional levels in the intervention group	Functional levels measured by SPPB in the intervention group	At Day 0 and Day 7 ± 7 days
Satisfaction with ED work-up	Patients' satisfaction with ED work-up assessed by questionnaire	Day 7 ± 7 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)	Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Occurence of falls	Occurence of falls following randomization from patient recollection	Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Roland Bingisser, Prof. Dr. med., Department of Emergency Medicine, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: fall; physiotherapy intervention; Ground Level Fall" (GLF); short International Falls efficacy scale (sFES-I)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2021-02165; am21Bingisser2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No