Lucerne Fall Risk Prediction Score for Stroke Rehabilitation

Completed

• Conditions: Stroke
• Interventions: Behavioral: Standard inpatient stroke rehabilitation

• Registration Number: NCT05135884
• Lead Sponsor: Luzerner Kantonsspital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

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

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Exclusion Criteria

• Re-rehabilitation due to a chronic stroke

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Standard inpatient stroke rehabilitation	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Luzerner Kantonsspital; 🇨🇭 Lucerne, Switzerland