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

Not Applicable

Completed

• Conditions: Fear of Falling

• Registration Number: NCT05156944
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-14
• Study Start: 2022-01-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in short International Falls efficacy scale (sFES-I)	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.

Secondary Outcome Measures

Name	Time	Method
Occurence of falls	Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days	Occurence of falls following randomization from patient recollection
Feasibility of the intervention	At Day 0	Feasibility of the intervention assessed by a questionnaire filled out by the physiotherapist
Change in short International Falls efficacy scale (sFES-I)	At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days	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.
Utilization of medical resources	Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days	Comparison of the use of medical resources between both groups (ED visits, GP visits, hospitalization, physiotherapy, imaging; all since inclusion)
Satisfaction with ED work-up	Day 7 ± 7 days	Patients' satisfaction with ED work-up assessed by questionnaire
Objective functional levels in the intervention group	At Day 0 and Day 7 ± 7 days	Functional levels measured by SPPB in the intervention group

Trial Locations

Locations (1)

Department of Emergency Medicine, University Hospital Basel; 🇨🇭 Basel, Switzerland