KinesiophobiaNCT06202287
Examining the Relationship Between the Presence of Kinesiophobia in Stroke Patients and Balance, Gait, Pain, and Social Participation Levels
An observational study of Kinesiophobia and Stroke, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to detect the presence of kinesiophobia, which may affect treatment in stroke patients, and to have an idea about its relationship with kinesiophobia by examining factors such as balance, gait, pain and social participation level. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kinesiophobia, Stroke
- What is being tested?
- Balance measurements using the HUR Smart balance device, balance tests, and other surveys.
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 15 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total of 50 stroke patients meeting the criteria will be included in the study.
Who may be able to join
- Being between the ages of 18 and 75 years old
- Having experienced post-stroke hemiplegia or hemiparesis
- Scoring at level 2 or above on the Functional Ambulation Classification
- Being willing to participate in the study and signing the consent forms"
Who cannot join
- Patients who cannot undergo mental evaluation, are unable to complete scales, are illiterate, or have aphasia
- Having major neurological or rheumatological pathologies affecting the musculoskeletal system other than stroke (Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.)
- Patients with diseases affecting balance (Parkinson's, Cerebral trauma, Meniere's disease, ear infections, Benign Paroxysmal Positional Vertigo, Multiple Sclerosis, etc.)
- Patients using medications that may disrupt balance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, 06800
About this study
The aim of this study is to detect the presence of kinesiophobia, which may affect treatment in stroke patients, and to have an idea about its relationship with kinesiophobia by examining factors such as balance, gait, pain and social participation level.
Read the detailed description
Individuals aged 18-75 with post-stroke hemiplegia or hemiparesis, a minimum Functional Ambulation Scale score of 2, and no major neurological or rheumatological pathology affecting the musculoskeletal system other than stroke (e.g., Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.), as well as those without diseases affecting balance (e.g., Parkinson's, Cerebral trauma, Meniere's disease, ear infection, Benign Paroxysmal Positional Vertigo, Multiple Sclerosis), and not using medications that disrupt balance, will be included in the study. Detailed medical histories will be obtained from all included patients and/or caregivers, and comprehensive musculoskeletal examinations will be conducted. Patient information, including name, surname, age, gender, occupation, education level, marital status, body mass index, duration of illness, stroke type, affected side, dominant side, and comorbidities, will be recorded.
All included patients in the study will be assessed by the same physician using the Functional Ambulation Scale, Community Integration Questionnaire , Mini-BESTest (Mini-Balance Evaluation Systems Test), balance assessment on the Hur Smart balance device, The Timed Up and Go Test , Tinetti Balance and Gait Test, Vas Kinesiophobia Scale., and Tampa Kinesiophobia Scale.
- Conditions
- Kinesiophobia, Stroke
- Being tested
- Balance measurements using the HUR Smart balance device, balance tests, and other surveys.
- Keywords
- Kinesiophobia, Stroke, balance, pain
- Medical subject headings
- Kinesiophobia, Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance measurements using the HUR Smart balance device, balance tests, and other surveys.Other
50 stroke patients will undergo balance measurements using the HUR Smart balance device and other tests.
| Study group | Role | What they receive |
|---|---|---|
| stroke patient | The specified tests will be administered to 50 patients who have experienced strokes and meet the criteria. Receives: Other: Balance measurements using the HUR Smart balance device, balance tests, and other surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Tampa Scale of Kinesiophobia
Scale, "The Tampa Kinesiophobia Scale (TKS) is a self-reported, 17-item scale developed to measure the fear of movement. A high score indicates a high level of fear of movement, while a low score suggests negligible levels of fear of movement.
Measured: baseline
Secondary outcomes (8)
Visual analogue scale
The Visual Analog Scale (VAS) is evaluated on a scale ranging from "no pain" to "worst possible pain." The value of 0 (zero) indicates "no pain," while the value of 10 (ten) indicates "the most severe pain imaginable."
Measured: baseline
Functional ambulation classification (FAC)
Scale, The FAC has six categories ranging from 0 (non-functional ambulation) to 5 (independent). The intermediary categories quantify levels of assistance, supervision, and independent but limited mobility.
Measured: baseline
Community Integration Questionnaire
Questionnaire,The community integration questionnaire (CIQ) was designed to assess home integration, social integration and productive activity in persons with acquired brain injury. The instrument consists of 15 items and can be completed by self report or with the assistance of a family member or caregiver familiar with the person's health status and social activities.
The community integration questionnaire (CIQ) was designed to assess home integration, social integration and productive activity in persons with acquired brain injury. The instrument consists of 15 items and can be completed by self report or with the assistance of a family member or caregiver familiar with the person's health status and social activities.
Measured: baseline
Mini-BESTest: Balance Evaluation Systems Test
The Mini-BESTest includes four subscales: transitions/anticipatory postural control, reactive postural control, sensory orientation and stability in gait. Each item is rated on a three-point ordinal scale(0 = severe to 2 = normal).The MiniBESTest consists of 14 items, with a maximum score of 28 points
Measured: baseline
The timed up and go test
A 3-meter distance in front of the chair is designated. The patient is asked to stand up from the chair, walk this distance, and then sit down again. The elapsed time provides the result of the test. If the patient takes longer than 12 seconds to complete this test, there is a risk of falling.
Measured: baseline
Tinetti balance and gait test
This test measures the patient's balance and gait ability. The maximum score for the gait component is 12, and for the balance component is 16. The overall maximum score is 28. Generally, patients scoring below 19 are at a high risk of falling.
Measured: baseline
VAS - Kinesiophobia Assessment
To measure motion fear, a Visual Analog Scale was used. A 10-centimeter horizontal line was drawn, ranging from 0 (no fear) at the beginning to 100 (severe fear) at the end. Participants were asked to stand up just before starting exercise and mark the intensity of their motion fear at that moment on the scale.
Measured: baseline
HUR Smart balance device
In the measurement of postural balance parameters, we utilized the HUR SMARTBALANCE BTG4 device and the accompanying software, HUR SmartBalance, available in our clinic. The device, through the balance platform, enables force measurements and load distribution, while sensors detect postural changes. The HUR SmartBalance software within the device provides various balance parameters based on these values, allowing for the assessment of the patient's balance
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Oct 2023
- Primary completion15 Jan 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Çakır, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202287
- Sponsor's protocol ID
- 10026499
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bak E, Mlynarska A, Marcisz C, Kadlubowska M, Marcisz-Dyla E, Sternal D, Mlynarski R, Krzeminska S. Kinesiophobia in Elderly Polish Patients After Ischemic Stroke, Including Frailty Syndrome. Neuropsychiatr Dis Treat. 2022 Mar 31;18:707-715. doi: 10.2147/NDT.S352151. eCollection 2022.
PubMed 35387207Wasiuk-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 33924856
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between the Presence of Kinesiophobia in Stroke Patients and Balance, Gait, Pain, and Social Participation Levels
- ClinicalTrials.gov ID
- NCT06202287
- Acronym / sponsor ID
- 10026499
- Conditions
- Kinesiophobia, Stroke
- Keywords
- Kinesiophobia, Stroke, balance, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 11 Jan 2024 (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.
The aim of this study is to detect the presence of kinesiophobia, which may affect treatment in stroke patients, and to have an idea about its relationship with kinesiophobia by examining factors such as balance, gait, pain and social participation level.
Detailed description
Individuals aged 18-75 with post-stroke hemiplegia or hemiparesis, a minimum Functional Ambulation Scale score of 2, and no major neurological or rheumatological pathology affecting the musculoskeletal system other than stroke (e.g., Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.), as well as those without diseases affecting balance (e.g., Parkinson's, Cerebral trauma, Meniere's disease, ear infection, Benign Paroxysmal Positional Vertigo, Multiple Sclerosis), and not using medications that disrupt balance, will be included in the study. Detailed medical histories will be obtained from all included patients and/or caregivers, and comprehensive musculoskeletal examinations will be conducted. Patient information, including name, surname, age, gender, occupation, education level, marital status, body mass index, duration of illness, stroke type, affected side, dominant side, and comorbidities, will be recorded.
All included patients in the study will be assessed by the same physician using the Functional Ambulation Scale, Community Integration Questionnaire , Mini-BESTest (Mini-Balance Evaluation Systems Test), balance assessment on the Hur Smart balance device, The Timed Up and Go Test , Tinetti Balance and Gait Test, Vas Kinesiophobia Scale., and Tampa Kinesiophobia Scale.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patient | – | Other: Balance measurements using the HUR Smart balance device, balance tests, and other surveys.The specified tests will be administered to 50 patients who have experienced strokes and meet the criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total of 50 stroke patients meeting the criteria will be included in the study.
Key inclusion criteria (4 listed)
- Being between the ages of 18 and 75 years old
- Having experienced post-stroke hemiplegia or hemiparesis
- Scoring at level 2 or above on the Functional Ambulation Classification
- Being willing to participate in the study and signing the consent forms"
Key exclusion criteria (4 listed)
- Patients who cannot undergo mental evaluation, are unable to complete scales, are illiterate, or have aphasia
- Having major neurological or rheumatological pathologies affecting the musculoskeletal system other than stroke (Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.)
- Patients with diseases affecting balance (Parkinson's, Cerebral trauma, Meniere's disease, ear infections, Benign Paroxysmal Positional Vertigo, Multiple Sclerosis, etc.)
- Patients using medications that may disrupt balance
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 |
|---|---|---|
| Balance measurements using the HUR Smart balance device, balance tests, and other surveys.50 stroke patients will undergo balance measurements using the HUR Smart balance device and other tests. | Other | stroke patient |
Primary outcome
The Tampa Scale of Kinesiophobia
Time frame: baseline
Scale, "The Tampa Kinesiophobia Scale (TKS) is a self-reported, 17-item scale developed to measure the fear of movement. A high score indicates a high level of fear of movement, while a low score suggests negligible levels of fear of movement.
8 secondary outcomes
Visual analogue scale
Time frame: baseline
Functional ambulation classification (FAC)
Time frame: baseline
Community Integration Questionnaire
Time frame: baseline
Mini-BESTest: Balance Evaluation Systems Test
Time frame: baseline
The timed up and go test
Time frame: baseline
Tinetti balance and gait test
Time frame: baseline
VAS - Kinesiophobia Assessment
Time frame: baseline
HUR Smart balance device
Time frame: baseline
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 7 Jan 2025.
- Background: PubMed 35387207Bak E, Mlynarska A, Marcisz C, Kadlubowska M, Marcisz-Dyla E, Sternal D, Mlynarski R, Krzeminska S. Kinesiophobia in Elderly Polish Patients After Ischemic Stroke, Including Frailty Syndrome. Neuropsychiatr Dis Treat. 2022 Mar 31;18:707-715. doi: 10.2147/NDT.S352151. eCollection 2022.
- 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.
Related trials for Kinesiophobia
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Transcranial Direct Current Stimulation and Manual Therapy on Musculoskeletal Pain in Adolescent Dancers
Musculoskeletal Pain, Chronic Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
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, run by Ankara City Hospital Bilkent 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 4 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 7 Jan 2025. 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 of Kinesiophobia (time frame: baseline). 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 NCT06202287, which also lists 2 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 7 Jan 2025.