Overview

This trial is active, not recruiting.

Condition accidental falls
Treatment not relevant
Sponsor Göteborg University
Start date October 2014
End date April 2017
Trial size 505 participants
Trial identifier NCT02264470, CUPersson

Summary

Falls after stroke are common. Previous research has shown that almost every other, 48%, of patients with a first-ever stroke fell at least once during the first year after stroke (1). Moreover, most of the patients fell during the first three months after stroke onset. However, the exact time-point for the falls was not analyzed (1). In addition, many patients are falling already during hospital stay (2-5). Reducing the number of falls during inpatient rehabilitation on a stroke unit is a high-priority mission. Greater knowledge concerning the factors that best predict falls is eligible.

The aim of the study is to analyze the significance of different physiological, psychological and medical factors for predicting the risk of falling in patients with stroke per day of care at a stroke unit.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All patients with stroke, 18 years or older, are asked for participation.
not relevant
Not relevant

Primary Outcomes

Measure
Fall/falls using MedControl Pro (no official possible expansions) and the medical journal
time frame: The participants will be followed and any fall will be registered during the hospital stay on a stroke unit, an expected average of 15 days.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with clinical stroke, whether first-ever or recurrent stroke and whether caused by cerebral infarction or cerebral hemorrhage - Patients 18 years old or older Exclusion Criterion: - Patients unwilling to participate in the study.

Additional Information

Official title Identification of Fall Risk in Patients With Stroke During Inpatient Rehabilitation on a Stroke Unit
Principal investigator Carina U Persson, PhD
Description Sample size assessment: According statistical consultation it is required to include at least 150 patients. The target figure is to include 500 patients. That number enables sub analyzes. Inclusion criterion: All patients with clinical stroke (infarction as bleeding, first-time or recurrent) at the stroke unit 354 will be asked for study participation. Exclusion criterion: Patients not willing to participate in the study. The response variable is fall. A fall is defined as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level. The definition of a fall refers to the World Health Organization (http://www.who.int/mediacentre/factsheets/fs344/en/ 2014-09-29). Data regarding falls will be collected from MedControl Pro (without any official possible expansions). MedControl Pro is a web based program for deviations. For validation of data concerning falls, assessment of GeM (Gemensam Melior, medical journal) will also be implemented. The significance of the following covariates will be used in the analyses: 1. The patient's confidence in their own balance (postural control). - Do you feel that your balance (postural control) is impaired? 2. Fear of falling - Are you afraid to fall? (Fear of falling) 3. Postural control in everyday activities - The modified version of the Postural Assessment Scale for Stroke Patients (SwePASS) 4. Postural control; tandem stance (A decisive moment?) - Do the patient manages tandem stance 30 s or not?/use of scale 0-4 5. Risk taking behaviour - Is the patient inclined to take a risk in tandem stance? 6. Self reported previous physical activity (PA) level. - Grimby & Saltin scale and/or 150 minutes of PA/week or not 7. Cognitive ability - Montreal Cognitive Assessment (MoCa) 8. Medication - Registration of drugs and their Anatomical Therapeutic Chemical (ATC) classification codes 9. Blood pressure - Blood pressure and pulse lying and after 1 and 3 minutes standing 10. The use of walking aids 11. The use of wheelchair 12. Age 13. Sex 14. Length of stay (in days) on the stroke unit. In addition, the National Institutes of Health Stroke Scale (NIHSS) result will be registered and used to describe the study population. Data collection: Data collection will take place once, as fast as possible but at the latest 4 days after admission to the stroke unit. There are two exceptions: First, data collection regarding drugs will take place day 4 after admission. However, in case of a fall before day 4 after admission, the data collection will be based on the drug list the current fall day. Second, data concerning cognition using MoCA will be performed once sometime during the stroke-unit stay (due to organisation issues). That is, not at any particular time, but the greater the suspicion of cognitive impairment, the later during the stroke unit stay. Statistical analysis: The poisson regression analysis will be used in order to address number of falls (fall risk) per day and night at the stroke unit. Poisson regression takes into account the wide variation in length of stay at the stroke unit.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Göteborg University.