In Stroke Patients, the Relationship Between Social Participation Level, Balance, Walking, Pain, and Kinesiophobia

January 10, 2024 updated by: Furkan Çakır, Ankara City Hospital Bilkent

Investigation of the Relationship Between Social Participation Level, Balance,Gait and Pain With Kinesiophobia in Stroke Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

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
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
        • Contact:

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

Total of 50 stroke patients meeting the criteria will be included in the study.

Description

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

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
stroke patient
The specified tests will be administered to 50 patients who have experienced strokes and meet the criteria.
Other: Balance 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Tampa Scale of Kinesiophobia
Time Frame: baseline
Scale, "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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: baseline
The 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."
baseline
Functional ambulation classification (FAC)
Time Frame: baseline
Scale, 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.
baseline
Community Integration Questionnaire
Time Frame: baseline

Questionnaire,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.
baseline
Mini-BESTest: Balance Evaluation Systems Test
Time Frame: baseline
The 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
baseline
The timed up and go test
Time Frame: baseline
A 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.
baseline
Tinetti balance and gait test
Time Frame: baseline
This 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.
baseline
VAS - Kinesiophobia Assessment
Time Frame: baseline
To 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.
baseline
HUR Smart balance device
Time Frame: baseline
In 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
baseline

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

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)

October 15, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10026499

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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