Assosiations Between Fear of Fall, Functional Ambulation Category and Quality of Life in Stroke Survivors

NCT04688060 | Completed

• 1 other identifier: KAEK/2019.04.09
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is one of the most common causes of acquired adult disability. The stroke survivors have lots of mobility difficulties such as poor standing, decreased walking speed, balance disturbances, and increased risk of falls (1). Falling is a major threat to stroke patients for physical injury. Fracture resulting from falling, could affect the rehabilitation potential and functional recovery (2,3). After a stroke, falls are one of the most common medical complications with a 73% incidence within the six months (4). In addition to physical components, psychological factors related falling include fear of falling(5). Fear of falling is defined as persisting concern regarding falling and associated with many negative physical and psychological factors (6,7). It not only affects a simple health concern, but also avoidance of activities and a loss of confidence (8). To determine the associating factors of fear of falling (FOF) and the correlations between FOF, functional ambulation category (FAC) and quality of life (QOL) on stroke patients.

Conditions

Fall

Keywords

fear of fall; quality of life; ambulation

Outcome Measures

Primary Outcomes (1)

• Falls Efficacy Scale-International (FES-I)

  assess the fear of falling level of participants about falling during indoor or outdoor activities minumum score 16 maximum score 64 low, moderate, and high concern (16-19, 20-27, and 28-64)

  basline

Study Arms (2)

fallers

stroke duration of 6 months or more follow 3-step commands, were able to walk 10m with no physical assistance with or without any assistive device, and scoring ≥3 on Functional Ambulation Category, and physically able to complete the testing procedure Patients who have fallen 1 or more times since stroke

Diagnostic Test: Falls Efficacy Scale-International (FES-I)

non-fallers

stroke duration of 6 months or more follow 3-step commands, were able to walk 10m with no physical assistance with or without any assistive device, and scoring ≥3 on Functional Ambulation Category, and physically able to complete the testing procedure. Patients who have not fallen 1 or more times since stroke

Diagnostic Test: Falls Efficacy Scale-International (FES-I)

Interventions

Falls Efficacy Scale-International (FES-I) DIAGNOSTIC_TEST

The FES-1 was used to assess the fear of falling level of participants about falling during indoor or outdoor activities. It has 16 items scored on a four-point Likert scale. The Turkish validated version of the FES-I was used in this study. The total score (sum of the 16 responses) ranging from 16 to 64 points was used for data analysis. A higher score indicates better mobility performance. A cut-off score of 27 points on the 16- item FES-I was used to differentiate high concern for falling from low concern

Also known as: Functional Ambulation Category (FAC), Stroke Impact Scale 3.0 (SIS)

fallers; non-fallers

Eligibility Criteria

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

Study Population

stroke duration of 6 months or more follow 3-step commands 18-65 years were able to walk 10m with no physical assistance with or without any assistive device

You may qualify if:

• stroke duration of 6 months or more
• follow 3-step commands
• were able to walk 10m with no physical assistance with or without any assistive device,
• scoring ≥3 on Functional Ambulation Category,
• physically able to complete the testing procedure.

You may not qualify if:

• other neurologic diagnosesor were medically unstable,
• lower-extremity fracture,
• other surgical procedures during the last 6 months
• were unable to provide consent.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Tuğba Şahbaz

Istanbul, Bakırköy, 34158, Turkey (Türkiye)

Location

Related Publications (4)

• Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.

  PMID: 20061508 BACKGROUND

• Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.

  PMID: 17908575 BACKGROUND

• Ansari NN, Naghdi S, Younesian P, Shayeghan M. Inter- and intrarater reliability of the Modified Modified Ashworth Scale in patients with knee extensor poststroke spasticity. Physiother Theory Pract. 2008 May-Jun;24(3):205-13. doi: 10.1080/09593980701523802.

  PMID: 18569857 BACKGROUND

• Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther. 1966 Apr;46(4):357-75. doi: 10.1093/ptj/46.4.357. No abstract available.

  PMID: 5907254 BACKGROUND

Related Links

• Hantal AÖ, Doğu B, Büyükavcı R, Kuran B. İnme etki ölçeği 3, 0: Türk toplumundaki inmeli hastalarda güvenilirlik ve geçerlilik çalışması. Türk Fiz Tıp Rehab Derg. 2014;60:106-16.

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor of physical medicine and rehabilitation

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 29, 2020
• Study Start: November 1, 2020
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)