Clinical trial NCT06202287: Examining the Relationship Between the Presence of Kinesiophobia in Stroke Patients and Balance, Gait, Pain, and Social Participation Levels
Official title: Examining the Relationship Between the Presence of Kinesiophobia in Stroke Patients and Balance, Gait, Pain, and Social Participation Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kinesiophobia
Stroke
Keywords: Kinesiophobia
Stroke
balance
pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total of 50 stroke patients meeting the criteria will be included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Tampa Scale of Kinesiophobia
timeFrame: baseline
Secondary outcomes:
measure: Visual analogue scale
timeFrame: baseline
measure: Functional ambulation classification (FAC)
timeFrame: baseline
measure: Community Integration Questionnaire
timeFrame: baseline
measure: Mini-BESTest: Balance Evaluation Systems Test
timeFrame: baseline
measure: The timed up and go test
timeFrame: baseline
measure: Tinetti balance and gait test
timeFrame: baseline
measure: VAS - Kinesiophobia Assessment
timeFrame: baseline
measure: HUR Smart balance device
timeFrame: baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Study officials:
References:
citation: 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.
citation: Wasiuk-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.