StrokeNCT07241429
Kinesiophobia and Balance in Stroke Patients
An observational study of Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This is a cross-sectional clinical study planned to include 138 stroke patients receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.Data on kinesiophobia (Tampa Kinesiophobia Scale-17) , balance performance (Berg Balance Scale) , balance confidence… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Survey using a questionnaire.
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The source population for this cross-sectional study is the adult patient population with a diagnosis of Stroke who are receiving inpatient physical medicine and rehabilitation services in a public training and research hospital setting in Turkey. Specifically, participants will be recruited from the İstanbul Physical Therapy and Rehabilitation Training and Research Hospital inpatient clinic. This setting provides access to a consecutive sample of individuals with varying degrees of functional deficits who are undergoing an organized rehabilitation program.
Who may be able to join
- Voluntary participation in the study
- Male and female patients aged 18-80
- History of ischemic or hemorrhagic stroke
- Functional Ambulation Scale level 3 or higher
- Standardized mini mental test ≥ 24
- Individuals who agree to participate in the study.
Who cannot join
- History of musculoskeletal surgery within the last year
- Trauma, fracture, dislocation, or tumor within the last year
- Vestibular system disorder
- Additional neurological disease that may affect balance (Parkinson's Disease, Multiple Sclerosis, vestibular system disorder)
- Other rheumatological or psychiatric diseases
- Chronic decompensated cardiac, renal, or hepatic failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Physical Therapy and Rehabilitation Training and Research Hospital
Istanbul, 34186
About this study
Official title: Kinesiophobia, Balance Performance, Fear of Falling, and Related Factors in Stroke Patients
This is a cross-sectional clinical study planned to include 138 stroke patients receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.Data on kinesiophobia (Tampa Kinesiophobia Scale-17) , balance performance (Berg Balance Scale) , balance confidence (Activities-specific Balance Confidence Scale-6) , fear of falling (Falls Efficacy Scale) , pain (VAS) , and mood (HADS) will be collected. Clinical and demographic data, including Brunnstrom stages and Barthel Index, will also be recorded. The relationships between these variables will be analyzed statistically.
Read the detailed description
This is a cross-sectional clinical study planned to include 138 stroke patients receiving inpatient treatment at the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Data on kinesiophobia (Tampa Kinesiophobia Scale-17) , balance performance (Berg Balance Scale) , balance confidence (Activities-specific Balance Confidence Scale-6) , fear of falling (Falls Efficacy Scale) , pain (VAS) , and mood (HADS) will be collected. Clinical and demographic data, including Brunnstrom stages and Barthel Index, will also be recorded. The relationships between these variables will be analyzed statistically
- Conditions
- Stroke
- Being tested
- Survey using a questionnaire.
- Keywords
- Kinesiophobia, Postural Balance, Fear of Falling, Stroke
- Medical subject headings
- Stroke, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
All participants in this single cohort will undergo a one-time, cross-sectional assessment. This assessment includes the collection of clinical and demographic data and the administration of scales for kinesiophobia (Tampa Kinesiophobia Scale-17), balance performance (Berg Balance Scale), balance confidence (ABC-6), fear of falling (Falls Efficacy Scale), pain (VAS), and mood (HADS). No intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Stroke Survivors | This observational group consists of 138 participants with a history of stroke (ischemic or hemorrhagic) who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital. Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Kinesiophobia using the Tampa Kinesiophobia Scale-17
The Tampa Kinesiophobia Scale-17 (TKS-17) is a 17-item scale assessing fear of movement. It uses a 4-point Likert scale (1=Strongly disagree to 4=Strongly agree). Items 4, 8, 12, and 16 are reverse-scored. The total score ranges from 17 (minimum) to 68 (maximum). A higher score indicates a higher degree of kinesiophobia.
Measured: at baseline assessment
Secondary outcomes (4)
Berg Balance Scale Score
A 14-item scale assessing postural control. Each item is scored 0 (unable) to 4 (normal performance), with a maximum score of 56.
Measured: at baseline assessment
Falls Efficacy Scale Score
A 10-item scale rating confidence in performing activities on a scale from 1 to 10. Total score ranges from 10 (minimum) to 100 (maximum). Higher scores indicate a higher level of fear of falling.
Measured: at baseline assessment
Hospital Anxiety and Depression Scale Score
A 14-item scale with 7 items for anxiety and 7 for depression, each scored 0-3. Each subscale (Anxiety, Depression) has a maximum score of 21
Measured: at baseline assessment
Barthel Index Score
Assessment of functional independence in activities of daily living.
Measured: at baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Nov 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241429
- Sponsor's protocol ID
- IstPRMTRH-EK4
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including all demographic, clinical, and primary/secondary outcome measures will be shared with qualified researchers. The sharing period will commence 6 months after article publication and conclude 1 year thereafter. Data access requests must be accompanied by a methodologically sound proposal and will be granted upon the corresponding author's approval and the execution of a Data Use Agreement (DUA) to strictly ensure confidentiality and adherence to ethical guidelines.
Publications
Pin TW, Winser SJ, Chan WLS, Chau B, Ng S, Wong T, Mak M, Pang M. Association between fear of falling and falls following acute and chronic stroke: a systematic review with meta-analysis. J Rehabil Med. 2024 Jan 16;56:jrm18650. doi: 10.2340/jrm.v56.18650.
PubMed 38226564Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
PubMed 21571152Batchelor FA, Mackintosh SF, Said CM, Hill KD. Falls after stroke. Int J Stroke. 2012 Aug;7(6):482-90. doi: 10.1111/j.1747-4949.2012.00796.x. Epub 2012 Apr 12.
PubMed 22494388
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia, Balance Performance, Fear of Falling, and Related Factors in Stroke Patients
- ClinicalTrials.gov ID
- NCT07241429
- Acronym / sponsor ID
- IstPRMTRH-EK4
- Conditions
- Stroke
- Keywords
- Kinesiophobia, Postural Balance, Fear of Falling, Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Nov 2025 (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.
This is a cross-sectional clinical study planned to include 138 stroke patients receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.Data on kinesiophobia (Tampa Kinesiophobia Scale-17) , balance performance (Berg Balance Scale) , balance confidence (Activities-specific Balance Confidence Scale-6) , fear of falling (Falls Efficacy Scale) , pain (VAS) , and mood (HADS) will be collected. Clinical and demographic data, including Brunnstrom stages and Barthel Index, will also be recorded. The relationships between these variables will be analyzed statistically.
Detailed description
This is a cross-sectional clinical study planned to include 138 stroke patients receiving inpatient treatment at the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Data on kinesiophobia (Tampa Kinesiophobia Scale-17) , balance performance (Berg Balance Scale) , balance confidence (Activities-specific Balance Confidence Scale-6) , fear of falling (Falls Efficacy Scale) , pain (VAS) , and mood (HADS) will be collected. Clinical and demographic data, including Brunnstrom stages and Barthel Index, will also be recorded. The relationships between these variables will be analyzed statistically
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient Stroke Survivors | – | Other: Survey using a questionnaire.This observational group consists of 138 participants with a history of stroke (ischemic or hemorrhagic) who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population for this cross-sectional study is the adult patient population with a diagnosis of Stroke who are receiving inpatient physical medicine and rehabilitation services in a public training and research hospital setting in Turkey. Specifically, participants will be recruited from the İstanbul Physical Therapy and Rehabilitation Training and Research Hospital inpatient clinic. This setting provides access to a consecutive sample of individuals with varying degrees of functional deficits who are undergoing an organized rehabilitation program.
Key inclusion criteria (6 listed)
- Voluntary participation in the study
- Male and female patients aged 18-80
- History of ischemic or hemorrhagic stroke
- Functional Ambulation Scale level 3 or higher
- Standardized mini mental test ≥ 24
Key exclusion criteria (6 listed)
- History of musculoskeletal surgery within the last year
- Trauma, fracture, dislocation, or tumor within the last year
- Vestibular system disorder
- Additional neurological disease that may affect balance (Parkinson's Disease, Multiple Sclerosis, vestibular system disorder)
- Other rheumatological or psychiatric diseases
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 |
|---|---|---|
| Survey using a questionnaire.All participants in this single cohort will undergo a one-time, cross-sectional assessment. This assessment includes the collection of clinical and demographic data and the administration of scales for kinesiophobia (Tampa Kinesiophobia Scale-17), balance performance (Berg Balance Scale), balance confidence (ABC-6), fear of falling (Falls Efficacy Scale), pain (VAS), and mood (HADS). No intervention is administered. | Other | Inpatient Stroke Survivors |
Primary outcome
Assessment of Kinesiophobia using the Tampa Kinesiophobia Scale-17
Time frame: at baseline assessment
The Tampa Kinesiophobia Scale-17 (TKS-17) is a 17-item scale assessing fear of movement. It uses a 4-point Likert scale (1=Strongly disagree to 4=Strongly agree). Items 4, 8, 12, and 16 are reverse-scored. The total score ranges from 17 (minimum) to 68 (maximum). A higher score indicates a higher degree of kinesiophobia.
4 secondary outcomes
Berg Balance Scale Score
Time frame: at baseline assessment
Falls Efficacy Scale Score
Time frame: at baseline assessment
Hospital Anxiety and Depression Scale Score
Time frame: at baseline assessment
Barthel Index Score
Time frame: at baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 38226564Pin TW, Winser SJ, Chan WLS, Chau B, Ng S, Wong T, Mak M, Pang M. Association between fear of falling and falls following acute and chronic stroke: a systematic review with meta-analysis. J Rehabil Med. 2024 Jan 16;56:jrm18650. doi: 10.2340/jrm.v56.18650.
- Results publication: PubMed 21571152Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Results publication: PubMed 22494388Batchelor FA, Mackintosh SF, Said CM, Hill KD. Falls after stroke. Int J Stroke. 2012 Aug;7(6):482-90. doi: 10.1111/j.1747-4949.2012.00796.x. Epub 2012 Apr 12.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including all demographic, clinical, and primary/secondary outcome measures will be shared with qualified researchers. The sharing period will commence 6 months after article publication and conclude 1 year thereafter. Data access requests must be accompanied by a methodologically sound proposal and will be granted upon the corresponding author's approval and the execution of a Data Use Agreement (DUA) to strictly ensure confidentiality and adherence to ethical guidelines.
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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.
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 Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eser Kalaoğlu, M.D. (+90 (212) 496 50 00 ext. 2126, eserkalaoglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Kinesiophobia using the Tampa Kinesiophobia Scale-17 (time frame: at baseline assessment). 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 NCT07241429, which also lists 3 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 28 Nov 2025.