- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06088342
The Relationship Between Kinesiophobia, Mobility, Postural Control and Fear of Falling in Patients With Stroke
The Relationship Between Kinesiophobia, Functional Mobility, Postural Control and Fear of Falling in Patients With Stroke
Stroke is a sudden decrease or cessation of blood flow to the brain. Two specific types of stroke account for the majority of stroke cases. Hemorrhagic strokes are caused by the rupture of a blood vessel within the brain, and ischemic strokes are caused by the blockage of an artery in the brain; Both conditions cause local hypoxia that damages brain tissue. Although both are serious and common, ischemic strokes are more common. Motor disorders after stroke manifest themselves as poor motor coordination, which also impairs mobility, as well as deterioration in muscle strength and tone. Post-stroke rehabilitation aims to help patients return to daily living activities by restoring the function of damaged muscles. One of the most fundamental problems of rehabilitation and daily life is decreased mobility. Biomedical understanding of kinesiophobia by assuming that the cause of the problem is the fear that physical activity will increase pain or disease symptoms. Kinesiophobia as the fear of experiencing physical or psychological discomfort.
Balance disorders are among the important factors affecting falls. Impaired postural control has a major impact on independence and gait in activities of daily living. Evaluation of postural balance in the subacute and chronic periods in stroke patients is an important factor in predicting the risk of falling. We believe that postural problems seen in stroke patients may affect kinesiophobia and fear of falling.
Pain and balance disorders seen in stroke patients can trigger the fear of falling, and the fear of falling can trigger the fear of moving.In approximately 60-70% of chronic stroke patients, poor self-esteem about falls is associated with increased anxiety and limitations in mobility balance. -qualification is declared.
Study Overview
Status
Conditions
Detailed Description
Kinesiophobia is defined as the fear of experiencing physical or psychological discomfort Postural control is necessary to maintain balance, control the body's position in space, and reflect the body's sensorimotor function. Poor trunk control affects balance and mobility in stroke patients and increases the risk of falls. Kinesiophobia can also significantly affect postural control The aim of this study is to examine the relationship between functional level, postural balance, fear of falling and kinesiophobia in patients with stroke. The secondary aim is to evaluate kinesiophobia according to the demographic information of stroke patients.
This study is a cross-sectional research. To determine the sample size, the power of the study was calculated using the G*Power Version 3.1.9.6 package program. Accordingly, it was determined that the sample size should be at least 40 to have a significance level of 0.05 and the power of the study to be 0.95. Sociodemographic information of stroke patients participating in the study will first be collected. Then, the Tampa Kinesiophobia Scale (TKS) will be used to evaluate kinesiophobia, the Timed Up and Go Test (TUG), the Trunk Impairment Scale (TIS) will be used to evaluate functional mobility and balance, and the Tinetti Fall Activity Scale will be used to evaluate the fear of falling. After the data are collected, the relationship between them will be analyzed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34144
- NPIstanbul Brain Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
ischemic or hemorrhagic stroke (confirmed by neuroimaging tests), Being over the age of 18 At least 3 months have passed since the stroke Having cognitive skills to fulfill the requirements of the study. 3. Volunteering to participate in the study.
MMSE score >21 points Could independently walk 6 meters (with assistive devices if any)
Exclusion Criteria:
- muscleskleteal disorders
- cognitive impairment suggesting moderate or severe dementia,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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study subjects
In this study, participants will participate in the study after reading and approving the informed consent form.
Volunteers participating in the study will first fill out the demographic information form.
Then, the volunteers will be administered the Tampa Kinesiophobia Scale, Timed Up and Go Test, Trunk Impairment Scale, and Tinetti Fall Effectiveness Scale.
This study is a correlation study.
Individuals' Tampa Kinesiophobia Scale results will be analyzed and interpreted with other scale results.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Tampa Scale for Kinesiophobia
Time Frame: Change from baseline
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Tampa kinesiophobia scale consists of 17 questions.
It is scored with a 4-point Likert scoring system.
1- I totally disagree 2- I disagree 3- I agree 4- I totally agree.
The 4th, 8th, 12th and 16th questions are reverse Likert.
The total score is between 17-68 points.
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Change from baseline
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Timed Up and Go Test (TUG)
Time Frame: Change from baseline
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In the timed up and go test, the individual stands up from a sitting position at a height of approximately 46 cm, walks 3 meters, turns back and sits down again.
The test is repeated twice.
Elapsed time is measured in seconds.
14 seconds or more is considered a high fall risk.
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Change from baseline
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Trunk Impairment Scale
Time Frame: Change from baseline
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It was developed in 2004.
This scale consists of 17 parameters.
Static and dynamic sitting balance and trunk coordination are evaluated.
The total score is minimum 0 and maximum 23 points.
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Change from baseline
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Tinetti Falls Efficacy Scale (FES)
Time Frame: Change from baseline
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It is a 10-item scale that evaluates perceived self-efficacy in preventing falls during basic daily living activities.
Getting in and out of bed, getting in and out of a chair, taking a bath or shower, dressing and undressing, reaching shelves, walking around the house, answering the door or phone, and preparing meals without lifting.
handling heavy objects and simple purchases.
Individuals give a score between 0 (very safe) and 10 (not safe) for each question, and when all scores are added up, a total score between 0 and 100 is obtained.
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Change from baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: selin kormaz erman, PT, Uskudar university
Publications and helpful links
General Publications
- Barthels D, Das H. Current advances in ischemic stroke research and therapies. Biochim Biophys Acta Mol Basis Dis. 2020 Apr 1;1866(4):165260. doi: 10.1016/j.bbadis.2018.09.012. Epub 2018 Sep 15.
- Yoo YJ, Lim SH. Assessment of Lower Limb Motor Function, Ambulation, and Balance After Stroke. Brain Neurorehabil. 2022 Jul 13;15(2):e17. doi: 10.12786/bn.2022.15.e17. eCollection 2022 Jul.
- Wasiuk-Zowada D, Knapik A, Szefler-Derela J, Brzek A, Krzystanek E. Kinesiophobia in Stroke Patients, Multiple Sclerosis and Parkinson's Disesase. Diagnostics (Basel). 2021 Apr 28;11(5):796. doi: 10.3390/diagnostics11050796.
- Gunaydin G, Gunaydin OE, Yakut H. Turkish Version, Validity and Reliability of the Lumbar Spine Instability Questionnaire. Turk Neurosurg. 2022;32(3):466-470. doi: 10.5137/1019-5149.JTN.35997-21.1.
- Fiedorova I, Mrazkova E, Zadrapova M, Tomaskova H. Receiver Operating Characteristic Curve Analysis of the Somatosensory Organization Test, Berg Balance Scale, and Fall Efficacy Scale-International for Predicting Falls in Discharged Stroke Patients. Int J Environ Res Public Health. 2022 Jul 27;19(15):9181. doi: 10.3390/ijerph19159181.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UskudarUniversity2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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