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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05156944
Other study ID # 2021-02165; am21Bingisser2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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