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Clinical Trials/NCT05156944
NCT05156944
Completed
Not Applicable

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

University Hospital, Basel, Switzerland1 site in 1 country104 target enrollmentJanuary 6, 2022
ConditionsFear of Falling

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fear of Falling
Sponsor
University Hospital, Basel, Switzerland
Enrollment
104
Locations
1
Primary Endpoint
Change in short International Falls efficacy scale (sFES-I)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2022
End Date
August 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Written informed consent
  • 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

Outcomes

Primary Outcomes

Change in short International Falls efficacy scale (sFES-I)

Time Frame: 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 Outcomes

  • Occurence of falls(Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Feasibility of the intervention(At Day 0)
  • Change in short International Falls efficacy scale (sFES-I)(At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Utilization of medical resources(Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Satisfaction with ED work-up(Day 7 ± 7 days)
  • Objective functional levels in the intervention group(At Day 0 and Day 7 ± 7 days)

Study Sites (1)

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