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Accidental FallsFallsGOTNCT02264470

Fall Study in Gothenburg (FallsGOT)

An observational study of Accidental Falls, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Accidental Falls
What is being tested?
Not relevant
How many people
505 participants
Where
1 siteSweden
Study dates
1 Oct 2014to 30 Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The group will consist of consecutively included patients with clinical stroke at the stroke unit at Sahlgrenska University Hospital/Östra, Gothenburg.

Who may be able to join

  • 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

Who cannot join

  • Patients unwilling to participate in the study.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital/Östra

    Gothenburg, Diagnosvägen 1, 416 85

Other trials in Sweden

About this study

Official title: Identification of Fall Risk in Patients With Stroke During Inpatient Rehabilitation on a Stroke Unit

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.

Read the detailed 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 medical journals 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?
  1. Fear of falling
  • Are you afraid to fall? (Fear of falling)
  1. Postural control in everyday activities
  • The modified version of the Postural Assessment Scale for Stroke Patients (SwePASS)
  1. Postural control; tandem stance (A decisive moment?)
  • Do the patient manages tandem stance 30 s or not?/use of scale 0-4
  1. Risk taking behaviour
  • Is the patient inclined to take a risk in tandem stance?
  1. Self reported previous physical activity (PA) level.
  • Grimby \& Saltin scale and/or 150 minutes of PA/week or not
  1. Cognitive ability
  • Montreal Cognitive Assessment (MoCa)
  1. Medication
  • Registration of drugs and their Anatomical Therapeutic Chemical (ATC) classification codes
  1. Blood pressure
  • Blood pressure and pulse lying and after 1 and 3 minutes standing
  1. The use of walking aids
  2. The use of wheelchair
  3. Age
  4. Sex
  5. 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.

Being tested
Not relevant
Keywords
Prediction, Falls, Stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Not relevantOther

    Not relevant

Study groups in NCT02264470
Study groupRoleWhat they receive
Patients with clinical strokeAll patients with stroke, 18 years or older, are asked for participation.
Receives: Other: Not relevant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fall/falls using MedControl Pro (no official possible expansions) and the medical journal

    The primary outcome, one fall, will be defined "as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level", according to the World Health Organization. Fall data is based on the numbers and description of falls documented in the medical journal and the falls registered in the MedControl. MedControl is a web-based system for deviations, here referred to falls. From the MedControl, time points (day, evening or night) and circumstances for and consequences of a fall/several falls (injury or not) will be used and registered. The estimated period of time over which a fall is/several falls are registered, extends from the admission day up to the day for discharge, an expected average of up to 15 days. The primary outcome measure will be assessed retrospectively from MedControl Pro and GeM within an expected average of a week after the discharge from the stroke unit.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study start1 Oct 2014
  3. Primary completion30 Jun 2016
  4. Study completion30 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264470
Sponsor's protocol ID
CUPersson
Acronym
FallsGOT
Status last verified
Nov 2018
First submitted
29 Sep 2014
Last updated
6 Nov 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Schnitzer L, Hansson PO, Samuelsson CM, Drummond A, Persson CU. Fatigue in stroke survivors: a 5-year follow-up of the Fall study of Gothenburg. J Neurol. 2023 Oct;270(10):4812-4819. doi: 10.1007/s00415-023-11812-0. Epub 2023 Jun 15.

    PubMed 37318549

  • Samuelsson CM, Hansson PO, Persson CU. Determinants of Recurrent Falls Poststroke: A 1-Year Follow-up of the Fall Study of Gothenburg. Arch Phys Med Rehabil. 2020 Sep;101(9):1541-1548. doi: 10.1016/j.apmr.2020.05.010. Epub 2020 Jun 1.

    PubMed 32497600

  • Westerlind EK, Lernfelt B, Hansson PO, Persson CU. Drug Treatment, Postural Control, and Falls: An Observational Cohort Study of 504 Patients With Acute Stroke, the Fall Study of Gothenburg. Arch Phys Med Rehabil. 2019 Jul;100(7):1267-1273. doi: 10.1016/j.apmr.2018.12.018. Epub 2019 Jan 3.

    PubMed 30610872

  • Laren A, Odqvist A, Hansson PO, Persson CU. Fear of falling in acute stroke: The Fall Study of Gothenburg (FallsGOT). Top Stroke Rehabil. 2018 May;25(4):256-260. doi: 10.1080/10749357.2018.1443876. Epub 2018 Mar 1.

    PubMed 29493399

Questions about this trial

What is this clinical trial studying?

An observational study of Accidental Falls, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02264470, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.

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