L-PRESTO: Lucerne Fall Risk Prediction Score for Stroke Rehabilitation

Sponsor
Luzerner Kantonsspital (Other)
Overall Status
Completed
CT.gov ID
NCT05135884
Collaborator
(none)
328
1
25
13.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard inpatient stroke rehabilitation

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
328 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Lucerne Fall Risk Prediction Score for Stroke Rehabilitation
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Cohort

Behavioral: Standard inpatient stroke rehabilitation
According to Swiss national guidelines and local protocols

Outcome Measures

Primary Outcome Measures

  1. Occurance of at least one fall [During inpatient stroke rehabilitation, an average of 6 weeks]

    Event of least one fall (yes/ no) during inpatient stroke rehabilitation

Secondary Outcome Measures

  1. Lucerne ICF Based Multidisciplinary Observational Scale (45-225 points, higher scores being better) [Rehabilitation admission]

    Activities of daily living

  2. Functional Independence Measure (18-126 points, higher scores being better) [Rehabilitation admission]

    Activities of daily living

  3. Montreal Cognitive Assessment (0-30 points, higher scores being better) [Rehabilitation admission]

    Cognitive function

  4. Apraxia Screen of Tulia (0-12 points, higher scores being better) [Rehabilitation admission]

    Apraxia

  5. Mini Balance Evaluation Systems Test (0-28 points, higher scores being better) [Rehabilitation admission]

    Balance

  6. 2-Minute Walk Test (meter, higher scores being better) [Rehabilitation admission]

    Gait speed and walking distance

  7. Timed up and go (seconds, lower scores being better) [Rehabilitation admission]

    Mobility

  8. Catherine Bergego Scale (0-30 points, lower scores being better) [Rehabilitation admission]

    Visuospatial function

  9. Language Screening Test (0-15 points, higher scores being better) [Rehabilitation admission]

    Speech function

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Acute/ subcute first or recurrent stroke

  • Inpatient rehabilitation

  • Signed general consent

Exclusion Criteria:
  • Re-rehabilitation due to a chronic stroke

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luzerner Kantonsspital Lucerne Switzerland 6000

Sponsors and Collaborators

  • Luzerner Kantonsspital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Janne Veerbeek, Principal Investigator, Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT05135884
Other Study ID Numbers:
  • L-PRESTO
First Posted:
Nov 26, 2021
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021