Fall Study in Gothenburg (FallsGOT)

NCT02264470 | Completed DMC

• 1 other identifier: CUPersson
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Accidental Falls

Keywords

Prediction; Falls; Stroke

Outcome Measures

Primary Outcomes (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.

  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.

Other Outcomes (4)

• Postural control in everyday activities using SwePASS (Modified version of the Postural Assessment Scale for Stroke Patients)

  Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit

• Postural control; tandem stance

  Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit

• Previous physical activity level using Grimby & Saltin's scale

  Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit

Study Arms (1)

Patients with clinical stroke

All patients with stroke, 18 years or older, are asked for participation.

Other: Not relevant

Interventions

Not relevant OTHER

Not relevant

Patients with clinical stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• Patients unwilling to participate in the study.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska University Hospital/Östra

Gothenburg, Diagnosvägen 1, 416 85, Sweden

Location

Related Publications (4)

• 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.

  PMID: 37318549 DERIVED

• 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.

  PMID: 32497600 DERIVED

• 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.

  PMID: 30610872 DERIVED

• 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.

  PMID: 29493399 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carina U Persson, PhD

  Göteborg University

  STUDY DIRECTOR

• Carina U Persson, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

• Carina U Persson, PhD

  Göteborg University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

SE (1)