Back to resultsEffect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall (EPAC-I)
Primary Purpose
Fear of Falling
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
physiotherapeutic intervention
Sponsored by
About this trial
This is an interventional other trial for Fear of Falling focused on measuring fall, Ground Level Fall" (GLF), physiotherapy intervention, short International Falls efficacy scale (sFES-I)
Eligibility Criteria
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
Sites / Locations
- Department of Emergency Medicine, University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Emergency department (ED) length of stay (hours)
Emergency department (ED) length of stay (hours)
Change in Hospital Anxiety and Depression Scale (HADS)
The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Change in Pain Numeric Rating Scale (NRS)
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain ('0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine"))
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.
Full Information
NCT ID
NCT05156944
First Posted
December 1, 2021
Last Updated
September 20, 2023
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT05156944
Brief Title
Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear of Falling
Keywords
fall, Ground Level Fall" (GLF), physiotherapy intervention, short International Falls efficacy scale (sFES-I)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physiotherapeutic intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in short International Falls efficacy scale (sFES-I)
Description
Change in the fear of falling between groups at day 7, 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.
Time Frame
At Day 0 and Day 7 ± 7 days
Secondary Outcome Measure Information:
Title
Emergency department (ED) length of stay (hours)
Description
Emergency department (ED) length of stay (hours)
Time Frame
At Day 0
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Time Frame
At Day 0 and Day 42 ± 3 days
Title
Change in Pain Numeric Rating Scale (NRS)
Description
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain ('0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine"))
Time Frame
At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Title
Change in short International Falls efficacy scale (sFES-I)
Description
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.
Time Frame
At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Bingisser, Prof. Dr. med.
Organizational Affiliation
Department of Emergency Medicine, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Emergency Medicine, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall
We'll reach out to this number within 24 hrs