Fear of MovementNCT05881499
The Effects of Earthquake on Fear of Movement and Fear of Falling
An observational study of Fear of Movement and Fear of Falling, run by Nagihan Acet at 1 site in Turkey (Türkiye).
Trial summary
In February-March 2023, a series of major earthquakes occurred in 11 provinces of Turkey (Adana, Adıyaman, Diyarbakır, Gaziantep, Hatay, Kahramanmaraş, Kilis, Malatya, Osmaniye, Şanlıurfa and Elazığ). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Movement, Fear of Falling
- How many people
- 185 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2023to 1 Sep 2023
- How long will I take part?
- 1 Month
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Uninjured survivors of the 2023 earthquake who voluntarily agree to participate will be included. For the current study, sample selection will be planned with the simple randomization method. The data will be collected through communication with local authorities at the aid points located in the earthquake-affected cities. Surveys will be conducted face-to-face with earthquake victims living in different cities.
Who may be able to join
- -being physically uninjured survivors of the 2023 earthquake in Turkey between the ages of 18 and 60
Who cannot join
- the presence of pre-existing cognitive and/or psychological illness
- physical injury status after the earthquake
- illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 2023 Earthquakes on Fear of Movement and Fear of Falling in Turkish Survivors: an Observational Cross-sectional Study
In February-March 2023, a series of major earthquakes occurred in 11 provinces of Turkey (Adana, Adıyaman, Diyarbakır, Gaziantep, Hatay, Kahramanmaraş, Kilis, Malatya, Osmaniye, Şanlıurfa and Elazığ). The current study is planned as a observational cross-sectional study with the participation of the survivors who experienced the 2023 earthquakes and aftershocks in Turkey without any physical injury during or after the earthquake. It is planned for the participants to fill out the questionnaires by considering the time periods before and after the earthquake. While the primary outcome is fear of movement and fear of falling, the secondary outcome is level of physical activity and intensity of pain. Psychological resilience level was considered as a predictive factor.
The aim of the current study is to determine the effect of earthquake experience on the fear of movement and falling in earthquake victims and to investigate the factors related with them. Fear of movement, fear of falling, level of physical activity, intensity of pain and psychological resilience are evaluated with the Causes of Fear of Movement Scale, Modified Falls Efficacy Scale, Short Form of International Physical Activity Questionnaire, Numerical Pain Scale and Connor-Davidson Psychological Resilience Scale respectively.
Read the detailed description
INTRODUCTION: Major earthquakes increase the risk of mental and emotional diseases such as anxiety disorders, sleep disorders and post-traumatic stress disorder as well as physical and biological complaints such as dizziness, vertigo and balance disorder.
An elaborate study conducted by Nomura et al., propounded the concept of Post-Earthquake Dizziness Syndrome (PEDS) for dizziness like features in earthquake victims. Their study also indicated that a previous history of vertigo was not related to the prevalence of PEDS. However, they noted that people prone to motion sickness were found to have a significantly higher prevalence of post-earthquake dizziness episodes.
In a previous review study conducted in 2021, the results showed that the prevalence of balance disorders increased significantly after the major earthquakes when compared to before the earthquakes. Exposure to major earthquakes and aftershocks has been shown to cause post-earthquake balance disorders by causing sensory conflicts mediated by vestibular dysfunction and/or psychological factors. In addition, that study stated that this increase in the prevalence of balance disorders may also be caused by psychological factors, which is consistent with previous studies in the literature.
The mechanisms of equilibrium dysfunction are likely to be explained by the sensory conflict theory/postural instability theory. The basic pathology of equilibrium dysfunction is attributed to disruption of interplay between vestibular, neurological, visual and proprioceptive functions of the human body. Psychological stress and maladaptive visual/somatosensory inputs caused by the earthquake may cause changes in the sense of movement, which is an important component of proprioception sense. Moreover, disruptions in the vestibular system may trigger the fear of falling, leading to decreases in physical activity capacity.
Although some previous studies have reported the presence of diziness or equilibrium disorders, in survivors after the earthquake, no study has investigated the fear of movement and fear of falling in these individuals.
Considering Turkey's geographical location in a high-risk seismic zone, determining the prevalence of fear of movement and falling in earthquake-exposed individuals would greatly contribute to the development of a better empirical approach to post-earthquake disaster management.
The primary aim of the present study is to determine the prevalence of fear of movement and falling in post-earthquake victims without physical injury, while the secondary aim is to reveal the relationship between these two parameters, as well as physical activity level, and pain intensity. Psychological resilliance is considered as a predictıve factor.
According to the the results of current study, it will be determined whether earthquake survivorship should be taken into account in preventing physical inactivity and related complications. In cases where this necessity is determined, rehabilitation programs should be revised depending on the earthquake victim's status.
MATERYAL-METHOD Design of the Study The present study is planned as a observational cross-sectional study and it will include victims of the 2023 earthquake in Türkey. Approval will be obtained from the Atılım University Ethics Committee with 02.05.2023 date and E-59394181-604.01.02-60355 number to be determined.
After providing information about the study, participants who voluntarily agree to participate will be included after obtaining written consent.
For the current study, sample selection will be planned with the simple randomization method. The advantages of this method are that it provides a fair chance for each unit in the population to be selected, eliminates potential biases, and allows for statistical inferences to be made.
The data will be collected through communication with local authorities at the aid points located in the earthquake-affected cities. Surveys will be conducted face-to-face with earthquake victims living in different cities.
In this study, participants will answer the questions by considering two different time periods: first considering the three-week period before the earthquake, and then considering the three-week period after the earthquake. The evaluation will be completed when there are no unanswered questions.
Participants The participants in this study will include individuals who meet the following inclusion criteria: they must be victims of the 2023 earthquake in Turkey and be between the ages of 18 and 60.
Exclusion criteria for participation in the study will be the presence of pre-existing cognitive and/or psychological illness, physical injury status after the earthquake, and illiteracy.
Data collection The primary outcomes of this study are fear of movement and fear of falling, while the secondary outcomes are the level of physical activity and intensity of pain. Psychological resilience level is considered as a predictive variable.
These outcomes will be assessed using the Causes of Fear of Movement Scale, Modified Falls Efficacy Scale, Short Form of International Physical Activity Questionnaire, Numerical Pain Scale, and Connor-Davidson Psychological Resilience Scale, respectively.
Sociodemographic characteristics The sociodemographic characteristics of the participants, such as age, height, weight, body mass index, education status, occupation, income status (income-expenditure relationship), presence of chronic diseases, shelter status, and marital status, will be recorded in a descriptive manner.
Assessment of fear of movement: The fear of movement will be assessed using the Turkish version of the Causes of Fear of Movement Scale. This questionnaire, developed by Janusz Kocjan et al. in 2014, consists of 20 questions and aims to diagnose and identify the causes of motor inactivity.
The questionnaire is divided into two parts, biological and psychological, to determine the reasons for the fear of movement. This structure enables the identification of individual causes of kinesiophobia and the determination of biological and psychological causes separately. The total score obtained from the questionnaire is calculated as the average of the scores obtained from the biological and physiological sub-dimensions. In the updated version from 2018, the total score ranges from 0 to 5. The scale uses a 5-point Likert scoring system (1=I totally disagree, 5=I totally agree). A high score indicates a higher level of fear of movement.
Asseement of fear of falling: The Modified Falls Efficacy Scale with 14 items (10 indoor and 4 outdoor activities) will be used to assess fear of falling. It evaluates participants' confidence during different daily tasks and is a reliable and valid scale for estimating balance and mobility problems. The scale includes items scored between 0 (not confident) and 10 (completely confident) to assess participants' self-efficacy levels regarding falling. The scale score is calculated by dividing the sum of the scores per question by the number of questions. High score means that the sense of safety and competence against falling are high. Cronbach's alpha internal consistency coefficient (ICC) of the scale was found to be 0.93. The Turkish version developed by Çetişli-Korkmaz et al. will be used in this study.
Level of Physical Activity: Turkish version of the Short Form of the International Physical Activity Questionnaire is used in order to determine the level of physical activity and sedentary lifestyles.
The durations of physical activities are multiplied by the Metabolic Equivalent of Task (MET) values per activity, and the results of all items are summed to create a total score for overall physical activity. Physical activity levels are classified into three categories: physically inactive (<600 MET min/week), low physical activity level (600-3000 MET min/week), and sufficient physical activity level (>3000 MET min/week).
Intensity of pain: A 10 cm Numerical Pain Scale will be used to determine the severity of pain, with numbers ranging from "0" (no pain) to "10" (unbearable pain).
Psychological Resilience Status: Psychological Resilience Status will be assessed using the Connor-Davidson Resilience Scale (CD-RISC-25). The Turkish version, developed by Karaırmak, consists of 25 questions and three sub-dimensions, namely perseverance and personal competence, tolerance for negative events and spiritual tendency. The first sub-dimension, 'perseverance and personal competence,' has a maximum score of 60, the second sub-dimension, 'tolerance for negative events,' has a maximum score of 24, and the third sub-dimension, 'spiritual tendency,' has a maximum score of 16. The scale uses a 5-point Likert-type scoring system, ranging from 0-4 points, with "never true" (0 points) to "almost always true" (4 points) as response options. The highest possible score is 100 points, indicating a higher level of psychological resilience as the score increases.
Sample size calculation: Sample size will be calculated after a pilot study.
Statistics:
The data collected from the participants will be analyzed using SPSS statistical software. Descriptive statistics such as mean, standard deviation, and frequency distributions will be used to describe the demographic characteristics and study variables. The normality of the distribution of the study variables will be tested using the Shapiro-Wilk test. If the distribution is normal, the paired sample t-test will be used to compare the pre- and post-earthquake scores of fear of movement, fear of falling, intensity of pain, and physical activity level. In case of non-normal distribution, the Wilcoxon signed-rank test will be used for analysis. Additionally, Pearson correlation coefficient analysis will be used to investigate the relationships between fear of movement, fear of falling, intensity of pain, and physical activity level. A significance level of p<0.05 will be used for all statistical tests.
- Conditions
- Fear of Movement, Fear of Falling
- Keywords
- Earthquake, Kinesiophobia
- Medical subject headings
- Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of movement
The fear of movement will be assessed using the Turkish version of the Causes of Fear of Movement Scale. The questionnaire is divided into two parts, biological and psychological, to determine the reasons for the fear of movement. This structure enables the identification of individual causes of kinesiophobia and the determination of biological and psychological causes separately. The scale uses a 5-point Likert scoring system (1=I totally disagree, 5=I totally agree). A high score in the questionnaire indicates that the individual has more fear of movement.
Measured: up to one month
Fear of falling
The Modified Falls Efficacy Scale with 14 items (10 indoor and 4 outdoor activities) will be used to assess fear of falling. It evaluates participants' confidence during different daily tasks and is a reliable and valid scale for estimating balance and mobility problems. The scale includes items scored between 0 (not confident) and 10 (completely confident) to assess participants' self-efficacy levels regarding falling. High score means that the sense of safety and competence against falling are high
Measured: up to one month
Secondary outcomes (3)
Level of physical activity
Turkish version of the Short Form of the International Physical Activity Questionnaire wiil be used in order to determine the level of physical activity and sedentary lifestyles.
The durations of physical activities are multiplied by the Metabolic Equivalent of Task (MET) values per activity, and the results of all items are summed to create a total score for overall physical activity. Physical activity levels are classified into three categories: physically inactive (<600 MET min/week), low physical activity level (600-3000 MET min/week), and sufficient physical activity level (>3000 MET min/week).
Measured: up to one month
Intensity of pain
A 10 cm Numerical Pain Scale will be used to determine the severity of pain, with numbers ranging from "0" (no pain) to "10" (unbearable pain)
Measured: up to one month
Psychological Resilience Status
Psychological Resilience Status will be assessed using the Connor-Davidson Resilience Scale. It consists of 25 questions and three sub-dimensions, namely perseverance and personal competence, tolerance for negative events and spiritual tendency.
The first sub-dimension, 'perseverance and personal competence,' has a maximum score of 60, the second sub-dimension, 'tolerance for negative events,' has a maximum score of 24, and the third sub-dimension, 'spiritual tendency,' has a maximum score of 16. The scale uses a 5-point Likert-type scoring system, ranging from 0-4 points, with "never true" (0 points) to "almost always true" (4 points) as response options. The highest possible score is 100 points, indicating a higher level of psychological resilience as the score increases.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start28 Jun 2023
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of MovementStudies 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
- 185 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Nagihan Acet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nagihan Acet, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881499
- Sponsor's protocol ID
- Atılım University
- Status last verified
- Nov 2023
- First submitted
- 3 May 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 2023 Earthquakes on Fear of Movement and Fear of Falling in Turkish Survivors: an Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05881499
- Acronym / sponsor ID
- Atılım University
- Conditions
- Fear of Movement, Fear of Falling
- Keywords
- Earthquake, Kinesiophobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Nagihan AcetUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 31 May 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.
In February-March 2023, a series of major earthquakes occurred in 11 provinces of Turkey (Adana, Adıyaman, Diyarbakır, Gaziantep, Hatay, Kahramanmaraş, Kilis, Malatya, Osmaniye, Şanlıurfa and Elazığ). The current study is planned as a observational cross-sectional study with the participation of the survivors who experienced the 2023 earthquakes and aftershocks in Turkey without any physical injury during or after the earthquake. It is planned for the participants to fill out the questionnaires by considering the time periods before and after the earthquake. While the primary outcome is fear of movement and fear of falling, the secondary outcome is level of physical activity and intensity of pain. Psychological resilience level was considered as a predictive factor.
The aim of the current study is to determine the effect of earthquake experience on the fear of movement and falling in earthquake victims and to investigate the factors related with them. Fear of movement, fear of falling, level of physical activity, intensity of pain and psychological resilience are evaluated with the Causes of Fear of Movement Scale, Modified Falls Efficacy Scale, Short Form of International Physical Activity Questionnaire, Numerical Pain Scale and Connor-Davidson Psychological Resilience Scale respectively.
Detailed description
INTRODUCTION: Major earthquakes increase the risk of mental and emotional diseases such as anxiety disorders, sleep disorders and post-traumatic stress disorder as well as physical and biological complaints such as dizziness, vertigo and balance disorder.
An elaborate study conducted by Nomura et al., propounded the concept of Post-Earthquake Dizziness Syndrome (PEDS) for dizziness like features in earthquake victims. Their study also indicated that a previous history of vertigo was not related to the prevalence of PEDS. However, they noted that people prone to motion sickness were found to have a significantly higher prevalence of post-earthquake dizziness episodes.
In a previous review study conducted in 2021, the results showed that the prevalence of balance disorders increased significantly after the major earthquakes when compared to before the earthquakes. Exposure to major earthquakes and aftershocks has been shown to cause post-earthquake balance disorders by causing sensory conflicts mediated by vestibular dysfunction and/or psychological factors. In addition, that study stated that this increase in the prevalence of balance disorders may also be caused by psychological factors, which is consistent with previous studies in the literature.
The mechanisms of equilibrium dysfunction are likely to be explained by the sensory conflict theory/postural instability theory. The basic pathology of equilibrium dysfunction is attributed to disruption of interplay between vestibular, neurological, visual and proprioceptive functions of the human body. Psychological stress and maladaptive visual/somatosensory inputs caused by the earthquake may cause changes in the sense of movement, which is an important component of proprioception sense. Moreover, disruptions in the vestibular system may trigger the fear of falling, leading to decreases in physical activity capacity.
Although some previous studies have reported the presence of diziness or equilibrium disorders, in survivors after the earthquake, no study has investigated the fear of movement and fear of falling in these individuals.
Considering Turkey's geographical location in a high-risk seismic zone, determining the prevalence of fear of movement and falling in earthquake-exposed individuals would greatly contribute to the development of a better empirical approach to post-earthquake disaster management.
The primary aim of the present study is to determine the prevalence of fear of movement and falling in post-earthquake victims without physical injury, while the secondary aim is to reveal the relationship between these two parameters, as well as physical activity level, and pain intensity. Psychological resilliance is considered as a predictıve factor.
According to the the results of current study, it will be determined whether earthquake survivorship should be taken into account in preventing physical inactivity and related complications. In cases where this necessity is determined, rehabilitation programs should be revised depending on the earthquake victim's status.
MATERYAL-METHOD Design of the Study The present study is planned as a observational cross-sectional study and it will include victims of the 2023 earthquake in Türkey. Approval will be obtained from the Atılım University Ethics Committee with 02.05.2023 date and E-59394181-604.01.02-60355 number to be determined.
After providing information about the study, participants who voluntarily agree to participate will be included after obtaining written consent.
For the current study, sample selection will be planned with the simple randomization method. The advantages of this method are that it provides a fair chance for each unit in the population to be selected, eliminates potential biases, and allows for statistical inferences to be made.
The data will be collected through communication with local authorities at the aid points located in the earthquake-affected cities. Surveys will be conducted face-to-face with earthquake victims living in different cities.
In this study, participants will answer the questions by considering two different time periods: first considering the three-week period before the earthquake, and then considering the three-week period after the earthquake. The evaluation will be completed when there are no unanswered questions.
Participants The participants in this study will include individuals who meet the following inclusion criteria: they must be victims of the 2023 earthquake in Turkey and be between the ages of 18 and 60.
Exclusion criteria for participation in the study will be the presence of pre-existing cognitive and/or psychological illness, physical injury status after the earthquake, and illiteracy.
Data collection The primary outcomes of this study are fear of movement and fear of falling, while the secondary outcomes are the level of physical activity and intensity of pain. Psychological resilience level is considered as a predictive variable.
These outcomes will be assessed using the Causes of Fear of Movement Scale, Modified Falls Efficacy Scale, Short Form of International Physical Activity Questionnaire, Numerical Pain Scale, and Connor-Davidson Psychological Resilience Scale, respectively.
Sociodemographic characteristics The sociodemographic characteristics of the participants, such as age, height, weight, body mass index, education status, occupation, income status (income-expenditure relationship), presence of chronic diseases, shelter status, and marital status, will be recorded in a descriptive manner.
Assessment of fear of movement: The fear of movement will be assessed using the Turkish version of the Causes of Fear of Movement Scale. This questionnaire, developed by Janusz Kocjan et al. in 2014, consists of 20 questions and aims to diagnose and identify the causes of motor inactivity.
The questionnaire is divided into two parts, biological and psychological, to determine the reasons for the fear of movement. This structure enables the identification of individual causes of kinesiophobia and the determination of biological and psychological causes separately. The total score obtained from the questionnaire is calculated as the average of the scores obtained from the biological and physiological sub-dimensions. In the updated version from 2018, the total score ranges from 0 to 5. The scale uses a 5-point Likert scoring system (1=I totally disagree, 5=I totally agree). A high score indicates a higher level of fear of movement.
Asseement of fear of falling: The Modified Falls Efficacy Scale with 14 items (10 indoor and 4 outdoor activities) will be used to assess fear of falling. It evaluates participants' confidence during different daily tasks and is a reliable and valid scale for estimating balance and mobility problems. The scale includes items scored between 0 (not confident) and 10 (completely confident) to assess participants' self-efficacy levels regarding falling. The scale score is calculated by dividing the sum of the scores per question by the number of questions. High score means that the sense of safety and competence against falling are high. Cronbach's alpha internal consistency coefficient (ICC) of the scale was found to be 0.93. The Turkish version developed by Çetişli-Korkmaz et al. will be used in this study.
Level of Physical Activity: Turkish version of the Short Form of the International Physical Activity Questionnaire is used in order to determine the level of physical activity and sedentary lifestyles.
The durations of physical activities are multiplied by the Metabolic Equivalent of Task (MET) values per activity, and the results of all items are summed to create a total score for overall physical activity. Physical activity levels are classified into three categories: physically inactive (<600 MET min/week), low physical activity level (600-3000 MET min/week), and sufficient physical activity level (>3000 MET min/week).
Intensity of pain: A 10 cm Numerical Pain Scale will be used to determine the severity of pain, with numbers ranging from "0" (no pain) to "10" (unbearable pain).
Psychological Resilience Status: Psychological Resilience Status will be assessed using the Connor-Davidson Resilience Scale (CD-RISC-25). The Turkish version, developed by Karaırmak, consists of 25 questions and three sub-dimensions, namely perseverance and personal competence, tolerance for negative events and spiritual tendency. The first sub-dimension, 'perseverance and personal competence,' has a maximum score of 60, the second sub-dimension, 'tolerance for negative events,' has a maximum score of 24, and the third sub-dimension, 'spiritual tendency,' has a maximum score of 16. The scale uses a 5-point Likert-type scoring system, ranging from 0-4 points, with "never true" (0 points) to "almost always true" (4 points) as response options. The highest possible score is 100 points, indicating a higher level of psychological resilience as the score increases.
Sample size calculation: Sample size will be calculated after a pilot study.
Statistics:
The data collected from the participants will be analyzed using SPSS statistical software. Descriptive statistics such as mean, standard deviation, and frequency distributions will be used to describe the demographic characteristics and study variables. The normality of the distribution of the study variables will be tested using the Shapiro-Wilk test. If the distribution is normal, the paired sample t-test will be used to compare the pre- and post-earthquake scores of fear of movement, fear of falling, intensity of pain, and physical activity level. In case of non-normal distribution, the Wilcoxon signed-rank test will be used for analysis. Additionally, Pearson correlation coefficient analysis will be used to investigate the relationships between fear of movement, fear of falling, intensity of pain, and physical activity level. A significance level of p<0.05 will be used for all statistical tests.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Uninjured survivors of the 2023 earthquake who voluntarily agree to participate will be included. For the current study, sample selection will be planned with the simple randomization method. The data will be collected through communication with local authorities at the aid points located in the earthquake-affected cities. Surveys will be conducted face-to-face with earthquake victims living in different cities.
Key inclusion criteria (1 listed)
- -being physically uninjured survivors of the 2023 earthquake in Turkey between the ages of 18 and 60
Key exclusion criteria (3 listed)
- the presence of pre-existing cognitive and/or psychological illness
- physical injury status after the earthquake
- illiteracy
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
Fear of movement
Time frame: up to one month
The fear of movement will be assessed using the Turkish version of the Causes of Fear of Movement Scale. The questionnaire is divided into two parts, biological and psychological, to determine the reasons for the fear of movement. This structure enables the identification of individual causes of kinesiophobia and the determination of biological and psychological causes separately. The scale uses a 5-point Likert scoring system (1=I totally disagree, 5=I totally agree). A high score in the questionnaire indicates that the individual has more fear of movement.
Fear of falling
Time frame: up to one month
The Modified Falls Efficacy Scale with 14 items (10 indoor and 4 outdoor activities) will be used to assess fear of falling. It evaluates participants' confidence during different daily tasks and is a reliable and valid scale for estimating balance and mobility problems. The scale includes items scored between 0 (not confident) and 10 (completely confident) to assess participants' self-efficacy levels regarding falling. High score means that the sense of safety and competence against falling are high
3 secondary outcomes
Level of physical activity
Time frame: up to one month
Intensity of pain
Time frame: up to one month
Psychological Resilience Status
Time frame: up to one month
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 10 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fear of Movement and Fear of Falling, run by Nagihan Acet 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 1 inclusion and 3 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 10 Oct 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?
Fear of movement (time frame: up to one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2024.