Lucerne Fall Risk Prediction Score for Stroke Rehabilitation (L-PRESTO)

November 16, 2021 updated by: Janne Veerbeek, Luzerner Kantonsspital

In Switzerland, every year around 16'000 people suffer a stroke. Stroke represents the third most common cause of death in Switzerland and leads to impairments (e.g., motoric, cognitive, sensory) resulting in disability. People with disabilities after stroke should have access to specialised interprofessional rehabilitation settings.

During inpatient rehabilitation, 15-36% of the patients experience one or more falls. It is well known that stroke is an important risk factor for falls. On average stroke patients fall 1.77 times more than the age- and gender-matched controls over 13 months. Falling events during inpatient stroke rehabilitation result in an extension of rehabilitation stay of about eleven days. Wong et al. (2016) suspect that a reduction in the activity level due to falls, fear of falling again as well as changes in discharge conditions could be the reason for this extended length of stay. Walsh et al. (2018) demonstrate that patients who fall once within the first year after stroke cause € 8'600 and recurrent fallers € 12'700 higher healthcare costs.

Fall risk factors after stroke are well investigated. Campbell & Matthews (2010) have collected multiple factors for falls in inpatient stroke rehabilitation from 1990 to 2009 in an integrative review. A newer systematic review points out physical function, hemi-attention, and stability as the most important factors for falls in inpatient stroke rehabilitation. However, none of the included studies showed a validated prediction model with acceptable performance. Hence, further investigations regarding the impact of various valid and reliable fall risk assessments at admission in inpatient rehabilitation are needed.

The neurorehabilitation team of LUKS systematically assesses the patient's functions and activity to design patient-specific, evidence-based rehabilitation. Therefore, a population-specific fall risk model based on standardized assessments performed in the clinical routine would help to identify patients with a high risk of falling during rehabilitation without the need of implementing an existing model with a low performance.

Aim of the study The main aim of this study is to establish a multivariable prediction model for falls during inpatient rehabilitation in acute and subacute stroke patients admitted to the Clinic for Neurology and Neurorehabilitation of the Kantonsspital Luzern (LUKS) in Lucerne, Switzerland.

The secondary aim is to explore the value of the mini-BESTest as a fall predictor in a subgroup consisting of patients who are ambulatory at admission to the Clinic for Neurology and Neurorehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

328

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland, 6000
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patiets admitted to inpatient neurorehabilitation after an acute stroke

Description

Inclusion Criteria:

  • Acute/ subcute first or recurrent stroke
  • Inpatient rehabilitation
  • Signed general consent

Exclusion Criteria:

- Re-rehabilitation due to a chronic stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Behavioral: Standard inpatient stroke rehabilitation
According to Swiss national guidelines and local protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurance of at least one fall
Time Frame: During inpatient stroke rehabilitation, an average of 6 weeks
Event of least one fall (yes/ no) during inpatient stroke rehabilitation
During inpatient stroke rehabilitation, an average of 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lucerne ICF Based Multidisciplinary Observational Scale (45-225 points, higher scores being better)
Time Frame: Rehabilitation admission
Activities of daily living
Rehabilitation admission
Functional Independence Measure (18-126 points, higher scores being better)
Time Frame: Rehabilitation admission
Activities of daily living
Rehabilitation admission
Montreal Cognitive Assessment (0-30 points, higher scores being better)
Time Frame: Rehabilitation admission
Cognitive function
Rehabilitation admission
Apraxia Screen of Tulia (0-12 points, higher scores being better)
Time Frame: Rehabilitation admission
Apraxia
Rehabilitation admission
Mini Balance Evaluation Systems Test (0-28 points, higher scores being better)
Time Frame: Rehabilitation admission
Balance
Rehabilitation admission
2-Minute Walk Test (meter, higher scores being better)
Time Frame: Rehabilitation admission
Gait speed and walking distance
Rehabilitation admission
Timed up and go (seconds, lower scores being better)
Time Frame: Rehabilitation admission
Mobility
Rehabilitation admission
Catherine Bergego Scale (0-30 points, lower scores being better)
Time Frame: Rehabilitation admission
Visuospatial function
Rehabilitation admission
Language Screening Test (0-15 points, higher scores being better)
Time Frame: Rehabilitation admission
Speech function
Rehabilitation admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Janne M. Veerbeek, PhD, Luzerner Kantonsspital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-PRESTO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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