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

NCT05156944 | Completed

• 1 other identifier: 2021-02165; am21Bingisser2
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Falling

Keywords

fall; Ground Level Fall" (GLF); physiotherapy intervention; short International Falls efficacy scale (sFES-I)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Feasibility of the intervention

  At Day 0

• Objective functional levels in the intervention group

  At Day 0 and Day 7 ± 7 days

• Satisfaction with ED work-up

  Day 7 ± 7 days

• 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

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Other: physiotherapeutic intervention

control group

NO INTERVENTION

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.

Interventions

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.

intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Written informed consent
• Age ≥65
• History of falls within the last 7 days
• Presentation to the ED of the University Hospital Basel

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Emergency Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Benhamou J, Espejo T, Riedel HB, Dreher-Hummel T, Garcia-Martinez A, Gubler-Gut B, Kirchberger J, Overberg JA, Perrot G, Bingisser R, Nickel CH. On-site physiotherapy in older emergency department patients following a fall: a randomized controlled trial. Eur Geriatr Med. 2025 Feb;16(1):205-217. doi: 10.1007/s41999-024-01091-x. Epub 2024 Nov 16.

  PMID: 39548032 DERIVED

Study Officials

• Roland Bingisser, Prof. Dr. med.

  Department of Emergency Medicine, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: January 6, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 11, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CH (1)