Skip to content

Examining the Relationship Between the Presence of Kinesiophobia in Stroke Patients and Balance, Gait, Pain, and Social Participation Levels

Examining the Relationship Between the Presence of Kinesiophobia in Stroke Patients and Balance, Gait, Pain, and Social Participation Levels

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06202287
Enrollment
50
Registered
2024-01-11
Start date
2023-10-15
Completion date
2024-04-15
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kinesiophobia, Stroke

Keywords

Kinesiophobia, Stroke, balance, pain

Brief 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.

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.

Interventions

OTHERBalance 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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The Tampa Scale of KinesiophobiabaselineScale, 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.

Secondary

MeasureTime frameDescription
Functional ambulation classification (FAC)baselineScale, 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.
Community Integration QuestionnairebaselineQuestionnaire,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.
Mini-BESTest: Balance Evaluation Systems TestbaselineThe 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
Visual analogue scalebaselineThe 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.
Tinetti balance and gait testbaselineThis 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.
VAS - Kinesiophobia AssessmentbaselineTo 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.
HUR Smart balance devicebaselineIn 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
The timed up and go testbaselineA 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026