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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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)

November 15, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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