Lucerne Fall Risk Prediction Score for Stroke Rehabilitation

Stroke Clinical Trial

— L-PRESTO  

Official title:

Lucerne Fall Risk Prediction Score for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05135884
• Other study ID #: L-PRESTO
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute/ subcute first or recurrent stroke

• Inpatient rehabilitation

• Signed general consent

Exclusion Criteria:

• Re-rehabilitation due to a chronic stroke

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

References & Publications (11)

Breisinger TP, Skidmore ER, Niyonkuru C, Terhorst L, Campbell GB. The Stroke Assessment of Fall Risk (SAFR): predictive validity in inpatient stroke rehabilitation. Clin Rehabil. 2014 Dec;28(12):1218-24. doi: 10.1177/0269215514534276. Epub 2014 May 21. — View Citation

Campbell GB, Matthews JT. An integrative review of factors associated with falls during post-stroke rehabilitation. J Nurs Scholarsh. 2010 Dec;42(4):395-404. doi: 10.1111/j.1547-5069.2010.01369.x. Epub 2010 Oct 13. Review. — View Citation

Flamand-Roze C, Falissard B, Roze E, Maintigneux L, Beziz J, Chacon A, Join-Lambert C, Adams D, Denier C. Validation of a new language screening tool for patients with acute stroke: the Language Screening Test (LAST). Stroke. 2011 May;42(5):1224-9. doi: 10.1161/STROKEAHA.110.609503. Epub 2011 Apr 12. — View Citation

Meyer K, Simmet A, Arnold M, Mattle H, Nedeltchev K. Stroke events, and case fatalities in Switzerland based on hospital statistics and cause of death statistics. Swiss Med Wkly. 2009 Feb 7;139(5-6):65-9. doi: smw-12448. — View Citation

National Institute for Health and Care Excellence. Stroke rehabilitation in adults. 2013. https://www.nice.org.uk/guidance/cg162/chapter/1-Recommendations#organising-health-and-social-care-for-people-needing-rehabilitation-after-stroke

Nyberg L, Gustafson Y. Patient falls in stroke rehabilitation. A challenge to rehabilitation strategies. Stroke. 1995 May;26(5):838-42. — View Citation

Persson CU, Kjellberg S, Lernfelt B, Westerlind E, Cruce M, Hansson PO. Risk of falling in a stroke unit after acute stroke: The Fall Study of Gothenburg (FallsGOT). Clin Rehabil. 2018 Mar;32(3):398-409. doi: 10.1177/0269215517728325. Epub 2017 Sep 11. — View Citation

Simpson LA, Miller WC, Eng JJ. Effect of stroke on fall rate, location and predictors: a prospective comparison of older adults with and without stroke. PLoS One. 2011 Apr 29;6(4):e19431. doi: 10.1371/journal.pone.0019431. — View Citation

Walsh ME, Horgan NF, Walsh CD, Galvin R. Systematic review of risk prediction models for falls after stroke. J Epidemiol Community Health. 2016 May;70(5):513-9. doi: 10.1136/jech-2015-206475. Epub 2016 Jan 14. Review. — View Citation

Walsh ME, Sorensen J, Galvin R, Williams DJ, Harbison JA, Murphy S, Collins R, McCabe DJ, Crowe M, Horgan NF. First year post-stroke healthcare costs and fall-status among those discharged to the community. Eur Stroke J. 2018 Sep;3(3):254-262. doi: 10.1177/2396987318764954. Epub 2018 Mar 15. — View Citation

Wong JS, Brooks D, Mansfield A. Do Falls Experienced During Inpatient Stroke Rehabilitation Affect Length of Stay, Functional Status, and Discharge Destination? Arch Phys Med Rehabil. 2016 Apr;97(4):561-566. doi: 10.1016/j.apmr.2015.12.005. Epub 2015 Dec 19. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurance of at least one fall	Event of least one fall (yes/ no) during inpatient stroke rehabilitation	During inpatient stroke rehabilitation, an average of 6 weeks
Secondary	Lucerne ICF Based Multidisciplinary Observational Scale (45-225 points, higher scores being better)	Activities of daily living	Rehabilitation admission
Secondary	Functional Independence Measure (18-126 points, higher scores being better)	Activities of daily living	Rehabilitation admission
Secondary	Montreal Cognitive Assessment (0-30 points, higher scores being better)	Cognitive function	Rehabilitation admission
Secondary	Apraxia Screen of Tulia (0-12 points, higher scores being better)	Apraxia	Rehabilitation admission
Secondary	Mini Balance Evaluation Systems Test (0-28 points, higher scores being better)	Balance	Rehabilitation admission
Secondary	2-Minute Walk Test (meter, higher scores being better)	Gait speed and walking distance	Rehabilitation admission
Secondary	Timed up and go (seconds, lower scores being better)	Mobility	Rehabilitation admission
Secondary	Catherine Bergego Scale (0-30 points, lower scores being better)	Visuospatial function	Rehabilitation admission
Secondary	Language Screening Test (0-15 points, higher scores being better)	Speech function	Rehabilitation admission