StrokeNCT06088342
The Relationship Between Kinesiophobia, Mobility, Postural Control and Fear of Falling in Patients With Stroke
An observational study of Stroke, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 23 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients diagnosed with stroke
Who may be able to join
- 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)
Who cannot join
- muscleskleteal disorders
- cognitive impairment suggesting moderate or severe dementia,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Keywords
- stroke, Balance, postural control, Quality of life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Tampa Scale for Kinesiophobia
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.
Measured: Change from baseline
Timed Up and Go Test (TUG)
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.
Measured: Change from baseline
Trunk Impairment Scale
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.
Measured: Change from baseline
Tinetti Falls Efficacy Scale (FES)
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.
Measured: Change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Oct 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Uskudar University
- Investigators
- selin kormaz erman, PT, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088342
- Sponsor's protocol ID
- UskudarUniversity2
- Status last verified
- Jan 2024
- First submitted
- 12 Oct 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31699365Yoo 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.
PubMed 36743203Wasiuk-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.
PubMed 33924856Gunaydin 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.
PubMed 35147970Fiedorova 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.
PubMed 35954533
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Kinesiophobia, Functional Mobility, Postural Control and Fear of Falling in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06088342
- Acronym / sponsor ID
- UskudarUniversity2
- Conditions
- Stroke
- Keywords
- stroke, Balance, postural control, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with stroke
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- muscleskleteal disorders
- cognitive impairment suggesting moderate or severe dementia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 31699365Barthels 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.
- Background: PubMed 36743203Yoo 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.
- Background: PubMed 33924856Wasiuk-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.
- Background: PubMed 35147970Gunaydin 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.
- Background: PubMed 35954533Fiedorova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
selin kormaz erman, PT principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Tampa Scale for Kinesiophobia (time frame: Change from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088342, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.