NCT06088342

Brief Summary

Stroke is a sudden decrease or cessation of blood flow to the brain. Two specific types of stroke account for the majority of stroke cases. Hemorrhagic strokes are caused by the rupture of a blood vessel within the brain, and ischemic strokes are caused by the blockage of an artery in the brain; Both conditions cause local hypoxia that damages brain tissue. Although both are serious and common, ischemic strokes are more common. Motor disorders after stroke manifest themselves as poor motor coordination, which also impairs mobility, as well as deterioration in muscle strength and tone. Post-stroke rehabilitation aims to help patients return to daily living activities by restoring the function of damaged muscles. One of the most fundamental problems of rehabilitation and daily life is decreased mobility. Biomedical understanding of kinesiophobia by assuming that the cause of the problem is the fear that physical activity will increase pain or disease symptoms. Kinesiophobia as the fear of experiencing physical or psychological discomfort. Balance disorders are among the important factors affecting falls. Impaired postural control has a major impact on independence and gait in activities of daily living. Evaluation of postural balance in the subacute and chronic periods in stroke patients is an important factor in predicting the risk of falling. We believe that postural problems seen in stroke patients may affect kinesiophobia and fear of falling. Pain and balance disorders seen in stroke patients can trigger the fear of falling, and the fear of falling can trigger the fear of moving.In approximately 60-70% of chronic stroke patients, poor self-esteem about falls is associated with increased anxiety and limitations in mobility balance. -qualification is declared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

October 12, 2023

Last Update Submit

January 23, 2024

Conditions

Keywords

strokeBalancepostural controlQuality of life

Outcome Measures

Primary Outcomes (4)

  • The Tampa Scale for Kinesiophobia

    Tampa kinesiophobia scale consists of 17 questions. It is scored with a 4-point Likert scoring system. 1- I totally disagree 2- I disagree 3- I agree 4- I totally agree. The 4th, 8th, 12th and 16th questions are reverse Likert. The total score is between 17-68 points.

    Change from baseline

  • Timed Up and Go Test (TUG)

    In the timed up and go test, the individual stands up from a sitting position at a height of approximately 46 cm, walks 3 meters, turns back and sits down again. The test is repeated twice. Elapsed time is measured in seconds. 14 seconds or more is considered a high fall risk.

    Change from baseline

  • Trunk Impairment Scale

    It was developed in 2004. This scale consists of 17 parameters. Static and dynamic sitting balance and trunk coordination are evaluated. The total score is minimum 0 and maximum 23 points.

    Change from baseline

  • Tinetti Falls Efficacy Scale (FES)

    It is a 10-item scale that evaluates perceived self-efficacy in preventing falls during basic daily living activities. Getting in and out of bed, getting in and out of a chair, taking a bath or shower, dressing and undressing, reaching shelves, walking around the house, answering the door or phone, and preparing meals without lifting. handling heavy objects and simple purchases. Individuals give a score between 0 (very safe) and 10 (not safe) for each question, and when all scores are added up, a total score between 0 and 100 is obtained.

    Change from baseline

Study Arms (1)

study subjects

In this study, participants will participate in the study after reading and approving the informed consent form. Volunteers participating in the study will first fill out the demographic information form. Then, the volunteers will be administered the Tampa Kinesiophobia Scale, Timed Up and Go Test, Trunk Impairment Scale, and Tinetti Fall Effectiveness Scale. This study is a correlation study. Individuals' Tampa Kinesiophobia Scale results will be analyzed and interpreted with other scale results.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients diagnosed with stroke

You may qualify if:

  • ischemic or hemorrhagic stroke (confirmed by neuroimaging tests), Being over the age of 18 At least 3 months have passed since the stroke Having cognitive skills to fulfill the requirements of the study. 3. Volunteering to participate in the study.
  • MMSE score \>21 points Could independently walk 6 meters (with assistive devices if any)

You may not qualify if:

  • muscleskleteal disorders
  • cognitive impairment suggesting moderate or severe dementia,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NPIstanbul Brain Hospital

Istanbul, 34144, Turkey (Türkiye)

Location

Related Publications (5)

  • Barthels D, Das H. Current advances in ischemic stroke research and therapies. Biochim Biophys Acta Mol Basis Dis. 2020 Apr 1;1866(4):165260. doi: 10.1016/j.bbadis.2018.09.012. Epub 2018 Sep 15.

    PMID: 31699365BACKGROUND
  • Yoo YJ, Lim SH. Assessment of Lower Limb Motor Function, Ambulation, and Balance After Stroke. Brain Neurorehabil. 2022 Jul 13;15(2):e17. doi: 10.12786/bn.2022.15.e17. eCollection 2022 Jul.

    PMID: 36743203BACKGROUND
  • 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.

    PMID: 33924856BACKGROUND
  • Gunaydin G, Gunaydin OE, Yakut H. Turkish Version, Validity and Reliability of the Lumbar Spine Instability Questionnaire. Turk Neurosurg. 2022;32(3):466-470. doi: 10.5137/1019-5149.JTN.35997-21.1.

    PMID: 35147970BACKGROUND
  • Fiedorova I, Mrazkova E, Zadrapova M, Tomaskova H. Receiver Operating Characteristic Curve Analysis of the Somatosensory Organization Test, Berg Balance Scale, and Fall Efficacy Scale-International for Predicting Falls in Discharged Stroke Patients. Int J Environ Res Public Health. 2022 Jul 27;19(15):9181. doi: 10.3390/ijerph19159181.

    PMID: 35954533BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • selin kormaz erman, PT

    Uskudar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

October 1, 2023

Primary Completion

January 23, 2024

Study Completion

January 23, 2024

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations