An observational study in Fall, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational
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.
This study was a cross-sectional observational study. Each participant was assessed with standardized questionnaires and examined. Eighty six hemiplegic cronic stroke patients were recruited from our clinic from March 2018 to December 2020 with informed consent. We divided the participants into two groups; with fallers and non-fallers.
The inclusion criteria were 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.
Exclusion criteria were other neurologic diagnosesor were medically unstable, lower-extremity fracture, or other surgical procedures during the last 6 months and were unable to provide consent.
All participants signed a written consent prior to participation in the study. The study was approved by the local institutional review board. The study was conducted in accordance with the Declaration of Helsinki ethical principles for human experimentation.
Demographic characteristics and medical history recorded by questionnaire included age, height, weight, comorbidities, number of medications, use of assistive device, date of stroke onset, and side of stroke, hemorrhagic or ischemic.
Falls history included number of falls during last 6 months or number of falls since the stroke onset, if stroke was less than 6 months prior. Fear of falling was assessed by asking subjects if they were afraid of falling (yes, no) and also ranking Falls Efficacy Scale-International (FES-I)(1).
Also functional ambulation levels, motor functions, spasticity and quality of life were assessed using Functional Ambulation Category (FAC), Brunnstrom staging, Modified Ashworth scale (MAS), Stroke Impact Scale 3.0 (SIS) (2-5).
Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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)
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)
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)
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)
Time frame: basline
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Kanuni Sultan Suleyman Training and Research Hospital