NCT06202287

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.

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 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 1, 2024

Last Update Submit

January 6, 2025

Conditions

KinesiophobiaStroke

Keywords

KinesiophobiaStrokebalancepain

Outcome Measures

Primary Outcomes (1)

  • The Tampa Scale of Kinesiophobia

    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 Outcomes (8)

  • Visual analogue scale

    baseline

  • Functional ambulation classification (FAC)

    baseline

  • Community Integration Questionnaire

    baseline

  • Mini-BESTest: Balance Evaluation Systems Test

    baseline

  • The timed up and go test

    baseline

  • +3 more secondary outcomes

Study Arms (1)

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.

Interventions

Balance measurements using the HUR Smart balance device, balance tests, and other surveys.OTHER

50 stroke patients will undergo balance measurements using the HUR Smart balance device and other tests.

stroke patient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 35387207BACKGROUND

  • 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

MeSH Terms

Conditions

KinesiophobiaStrokePain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 1, 2024

First Posted

January 11, 2024

Study Start

October 15, 2023

Primary Completion

January 15, 2024

Study Completion

April 15, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

TU(1)