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Completed

NCT Number: NCT05156944

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

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.

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Key information

Conditions

Fear of Falling

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Emergency Medicine, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physiotherapeutic intervention

Other

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 outcomes

  1. 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

  1. Feasibility of the intervention

    Time frame: At Day 0

    Feasibility of the intervention assessed by a questionnaire filled out by the physiotherapist

  2. Objective functional levels in the intervention group

    Time frame: At Day 0 and Day 7 ± 7 days

    Functional levels measured by SPPB in the intervention group

  3. Satisfaction with ED work-up

    Time frame: Day 7 ± 7 days

    Patients' satisfaction with ED work-up assessed by questionnaire

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

    Time frame: 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.

  5. Utilization of medical resources

    Time frame: 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)

  6. Occurence of falls

    Time frame: Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days

    Occurence of falls following randomization from patient recollection

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: EPAC-I

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2021
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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