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

Sponsor
Uskudar University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06088342
Collaborator
(none)
40
1
3
13.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Relationship Between Kinesiophobia, Functional Mobility, Postural Control and Fear of Falling in Patients With Stroke
    Actual Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. The Tampa Scale for Kinesiophobia [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) [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 [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NPIstanbul Brain Hospital Istanbul Turkey 34144

    Sponsors and Collaborators

    • Uskudar University

    Investigators

    • Principal Investigator: selin kormaz erman, PT, Uskudar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    osman coban, Asst. Prof., Uskudar University
    ClinicalTrials.gov Identifier:
    NCT06088342
    Other Study ID Numbers:
    • UskudarUniversity2
    First Posted:
    Oct 18, 2023
    Last Update Posted:
    Oct 18, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by osman coban, Asst. Prof., Uskudar University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 18, 2023