Kinesiophobia and Balance in Stroke Patients

November 21, 2025 updated by: Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34186
        • Recruiting
        • Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at baseline assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale Score
Time Frame: at baseline assessment
A 14-item scale assessing postural control. Each item is scored 0 (unable) to 4 (normal performance), with a maximum score of 56.
at baseline assessment
Falls Efficacy Scale Score
Time Frame: at baseline assessment
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.
at baseline assessment
Hospital Anxiety and Depression Scale Score
Time Frame: at baseline assessment
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
at baseline assessment
Barthel Index Score
Time Frame: at baseline assessment
Assessment of functional independence in activities of daily living.
at baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstPRMTRH-EK4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months and ending 1 year following article publication.

IPD Sharing Access Criteria

Qualified researchers who present a methodologically robust proposal aimed at fulfilling the objectives of the approved project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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