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Completed

NCT Number: NCT06088342

The Relationship Between Kinesiophobia, 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NPIstanbul Brain Hospital

Istanbul, 34144, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  1. The Tampa Scale for Kinesiophobia

    Time frame: Change from baseline

    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.

  2. Timed Up and Go Test (TUG)

    Time frame: Change from baseline

    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.

  3. Trunk Impairment Scale

    Time frame: Change from baseline

    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.

  4. Tinetti Falls Efficacy Scale (FES)

    Time frame: Change from baseline

    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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

The Relationship Between Kinesiophobia, Functional Mobility, Postural Control and Fear of Falling in Patients With Stroke

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2023
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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