NCT06061887

Brief Summary

The goal of this observational study is to learn about the recurrent falls in patients with acute stroke. The main question\[s\] it aims to answer are:

  • what is the frequency of recurrent falls
  • which factors are associated with recurrent falls in patients with acute stroke. Participants will be evaluated in terms of
  • frequency of recurrent falls within the six months after stroke
  • fear of falling
  • the stroke severity (Canadian Neurological Scale),
  • ambulation level (Functional Ambulation Classification),
  • functional disability (Functional Independence Scale)
  • Postural control and balance
  • functional status (Modified Rankin Scale)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

March 8, 2023

Last Update Submit

September 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of fall

    The frequency of recurrent falls were were determined by questioning the patients.

    Six month

Secondary Outcomes (1)

  • Factors related with recurrent falls

    Six month

Interventions

Evaluation of the frequency of falls in patients with acute stroke and determining the risk factors associated with recurrent falls within the first six months after stroke

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18 and over, hospitalized in the neurology service with the diagnosis of acute stroke

You may qualify if:

  • Having an acute stroke over the age of 18
  • To have a cognitive situation to understand and answer questions

You may not qualify if:

  • Patients with bilateral hemiplegia
  • Patients without motor involvement
  • Those with a history of stroke
  • Patients with severe cognitive impairment
  • Patients in need of intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Altınay Göksel Karatepe, MD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2023

First Posted

September 29, 2023

Study Start

March 31, 2021

Primary Completion

February 28, 2023

Study Completion

March 28, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations