KinesiophobiaNCT05538468
Kinesiophobia in Stroke Patients and Affecting Factors
An observational study of Kinesiophobia and Stroke Patients, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to determine the presence of kinesiophobia that will affect the treatment in stroke patients and to investigate the relationship between these factors and kinesiophobia by examining factors such as postural control, depression, pain, and affected side that may cause kinesiophobia. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Kinesiophobia, Stroke Patients
- What is being tested?
- Assessment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2019to 30 Jul 2019
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients who were level 2 and above according to the Functional Ambulation Classification were included in the study.
Who may be able to join
- individuals who were diagnosed with hemiplegia or hemiparesis after SVO,
- at least 6 months after SVO,
- who were Level 2 and above according to the Functional Ambulation Classification,
- who wanted to participate in the study voluntarily
Who cannot join
- Anyone with a major neurological or rheumatological pathology (polyneuropathy, parkinson's, multiple sclerosis, rheumatoid arthritis, etc.)
- Affecting the musculoskeletal system other than stroke
- Who does not allow mental evaluation, cannot fill in the scales,
- is illiterate, has aphasia, has a history of falling,
- have any cardiac problems,
- amputation in the lower extremities,
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- those with active malignancy and related chemo/radiotherapy,
- the presence of accompanying lower motor neuron or peripheral nerve lesion,
- any musculoskeletal problem and related pain (lumbar disc herniation, meniscus, etc.),
- ındividuals with shoulder subluxation, shoulder-hand syndrome
- those who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Depression, Postural Control, Pain, Affected Side and Kinesiophobia in Stroke Patients
It was aimed to determine the presence of kinesiophobia that will affect the treatment in stroke patients and to investigate the relationship between these factors and kinesiophobia by examining factors such as postural control, depression, pain, and affected side that may cause kinesiophobia.
Read the detailed description
Objective: This study was planned to investigate the relationship between depression, postural control, pain, affected side and kinesiophobia in stroke patients. Material and Method: Thirty patients aged between 25-70 years who had a stroke at the earliest 6 months and who Functional Ambulation Scale were level 2 and above according to the were included in the study. Patients were selected by random sampling method from the relevant population. Demographic data were obtained from all subjects who met the inclusion criteria. Patients were evaluated Kinesiophobia scores (Tampa Kinesiophobia Scale (TKÖ) and VAS-Kinesiophobia Assessment), depression severity (Beck Depression Inventory), postural control loss (PASS) and pain severity (VAS).
- Conditions
- Kinesiophobia, Stroke Patients
- Being tested
- Assessment
- Keywords
- Kinesiophobia, stroke patients, Pain, Postural control, Depression
- Medical subject headings
- Kinesiophobia, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Thirty stroke patients were included in the study. After the demographic information was obtained from all patients who accepted to participate in the study by complying with the inclusion criteria; The kinesiophobia scores of the patients were evaluated, depression severity, postural control and pain severity.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Patients Group | The kinesiophobia scores of the patients were evaluated by (Tampa Kinesiophobia Scale) and (Visual Analog Scale- Kinesiophobia Assessment), depression severity (Beck Depression Inventory), postural control (Postural Assessment Scale), pain severity (Visual Analog Scale). Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia Assessment
VAS Kinesiophobia Assessment were used. The Visual Analog Scale was used as the second method in the assessment of kinesiophobia. A scale is drawn on a 10-centimeter (cm) horizontal line to show the start as 0 (no fear of movement) and the end as 100 (violent fear of movement). They were asked to stand up just before starting the exercise and to mark the severity of the fear of movement they felt at that moment on the scale.
Measured: 6 mounts
Kinesiophobia Assessment
Tampa Kinesiophobia Scale were used. The Tampa Kinesiophobia Scale (TKS) is one of them, and it's commonly used in the literature to assess kinesiophobia. It has 17 questions designed to assess fear of moving.
Measured: 6 mounts
Pain Assessment
Pain Assessment Visual Analogue Scale (VAS) was used. On a 10-centimeter (cm) horizontal line, start 0 (no pain) and finish 10 (unbearable pain) are marked and the subjects were asked to place a mark on this horizontal line according to the degree of pain they felt. The point marked on the line was then measured with the help of a ruler and recorded as the VAS value in cm.
Measured: 6 mounts
Postural Control Assessment
Postural Assessment Scale for Stroke Patients (PASS) was used. The scale, which consists of 12 items, is grouped at 4 different levels (0-3). It is a 2-part scale that assesses the ability to maintain the posture (5 items) and change it (7 items).
Measured: 6 mounts
Depression Severity Assessment
Depression Severity Assessment, The Beck Depression Inventory (BDI) was employed, which consists of 21 questions. The scale has a range of 0 to 84 points.
Measured: 6 mounts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start10 Feb 2019
- Primary completion15 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538468
- Sponsor's protocol ID
- 2019/3-22
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Depression, Postural Control, Pain, Affected Side and Kinesiophobia in Stroke Patients
- ClinicalTrials.gov ID
- NCT05538468
- Acronym / sponsor ID
- 2019/3-22
- Conditions
- Kinesiophobia, Stroke Patients
- Keywords
- Kinesiophobia, stroke patients, Pain, Postural control, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 13 Sep 2022 (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.
It was aimed to determine the presence of kinesiophobia that will affect the treatment in stroke patients and to investigate the relationship between these factors and kinesiophobia by examining factors such as postural control, depression, pain, and affected side that may cause kinesiophobia.
Detailed description
Objective: This study was planned to investigate the relationship between depression, postural control, pain, affected side and kinesiophobia in stroke patients. Material and Method: Thirty patients aged between 25-70 years who had a stroke at the earliest 6 months and who Functional Ambulation Scale were level 2 and above according to the were included in the study. Patients were selected by random sampling method from the relevant population. Demographic data were obtained from all subjects who met the inclusion criteria. Patients were evaluated Kinesiophobia scores (Tampa Kinesiophobia Scale (TKÖ) and VAS-Kinesiophobia Assessment), depression severity (Beck Depression Inventory), postural control loss (PASS) and pain severity (VAS).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients Group | – | Other: AssessmentThe kinesiophobia scores of the patients were evaluated by (Tampa Kinesiophobia Scale) and (Visual Analog Scale- Kinesiophobia Assessment), depression severity (Beck Depression Inventory), postural control (Postural Assessment Scale), pain severity (Visual Analog Scale). |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients who were level 2 and above according to the Functional Ambulation Classification were included in the study.
Key inclusion criteria (4 listed)
- individuals who were diagnosed with hemiplegia or hemiparesis after SVO,
- at least 6 months after SVO,
- who were Level 2 and above according to the Functional Ambulation Classification,
- who wanted to participate in the study voluntarily
Key exclusion criteria (11 listed)
- Anyone with a major neurological or rheumatological pathology (polyneuropathy, parkinson's, multiple sclerosis, rheumatoid arthritis, etc.)
- Affecting the musculoskeletal system other than stroke
- Who does not allow mental evaluation, cannot fill in the scales,
- is illiterate, has aphasia, has a history of falling,
- have any cardiac problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentThirty stroke patients were included in the study. After the demographic information was obtained from all patients who accepted to participate in the study by complying with the inclusion criteria; The kinesiophobia scores of the patients were evaluated, depression severity, postural control and pain severity. | Other | Stroke Patients Group |
Primary outcome
Kinesiophobia Assessment
Time frame: 6 mounts
VAS Kinesiophobia Assessment were used. The Visual Analog Scale was used as the second method in the assessment of kinesiophobia. A scale is drawn on a 10-centimeter (cm) horizontal line to show the start as 0 (no fear of movement) and the end as 100 (violent fear of movement). They were asked to stand up just before starting the exercise and to mark the severity of the fear of movement they felt at that moment on the scale.
Kinesiophobia Assessment
Time frame: 6 mounts
Tampa Kinesiophobia Scale were used. The Tampa Kinesiophobia Scale (TKS) is one of them, and it's commonly used in the literature to assess kinesiophobia. It has 17 questions designed to assess fear of moving.
Pain Assessment
Time frame: 6 mounts
Pain Assessment Visual Analogue Scale (VAS) was used. On a 10-centimeter (cm) horizontal line, start 0 (no pain) and finish 10 (unbearable pain) are marked and the subjects were asked to place a mark on this horizontal line according to the degree of pain they felt. The point marked on the line was then measured with the help of a ruler and recorded as the VAS value in cm.
Postural Control Assessment
Time frame: 6 mounts
Postural Assessment Scale for Stroke Patients (PASS) was used. The scale, which consists of 12 items, is grouped at 4 different levels (0-3). It is a 2-part scale that assesses the ability to maintain the posture (5 items) and change it (7 items).
Depression Severity Assessment
Time frame: 6 mounts
Depression Severity Assessment, The Beck Depression Inventory (BDI) was employed, which consists of 21 questions. The scale has a range of 0 to 84 points.
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 13 Sep 2022.
- 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.
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 Kinesiophobia and Stroke Patients, run by Inonu 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 4 inclusion and 11 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 13 Sep 2022. 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?
Kinesiophobia Assessment (time frame: 6 mounts). The study lists 5 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 13 Sep 2022.