NCT07241429

Brief Summary

This is a cross-sectional clinical study planned to include 138 stroke patients receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.Data on kinesiophobia (Tampa Kinesiophobia Scale-17) , balance performance (Berg Balance Scale) , balance confidence (Activities-specific Balance Confidence Scale-6) , fear of falling (Falls Efficacy Scale) , pain (VAS) , and mood (HADS) will be collected. Clinical and demographic data, including Brunnstrom stages and Barthel Index, will also be recorded. The relationships between these variables will be analyzed statistically.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 17, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

KinesiophobiaPostural BalanceFear of FallingStroke

Outcome Measures

Primary Outcomes (1)

  • Assessment of Kinesiophobia using the Tampa Kinesiophobia Scale-17

    The Tampa Kinesiophobia Scale-17 (TKS-17) is a 17-item scale assessing fear of movement. It uses a 4-point Likert scale (1=Strongly disagree to 4=Strongly agree). Items 4, 8, 12, and 16 are reverse-scored. The total score ranges from 17 (minimum) to 68 (maximum). A higher score indicates a higher degree of kinesiophobia.

    at baseline assessment

Secondary Outcomes (4)

  • Berg Balance Scale Score

    at baseline assessment

  • Falls Efficacy Scale Score

    at baseline assessment

  • Hospital Anxiety and Depression Scale Score

    at baseline assessment

  • Barthel Index Score

    at baseline assessment

Study Arms (1)

Inpatient Stroke Survivors

This observational group consists of 138 participants with a history of stroke (ischemic or hemorrhagic) who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.

Other: Survey using a questionnaire.

Interventions

All participants in this single cohort will undergo a one-time, cross-sectional assessment. This assessment includes the collection of clinical and demographic data and the administration of scales for kinesiophobia (Tampa Kinesiophobia Scale-17), balance performance (Berg Balance Scale), balance confidence (ABC-6), fear of falling (Falls Efficacy Scale), pain (VAS), and mood (HADS). No intervention is administered.

Inpatient Stroke Survivors

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The source population for this cross-sectional study is the adult patient population with a diagnosis of Stroke who are receiving inpatient physical medicine and rehabilitation services in a public training and research hospital setting in Turkey. Specifically, participants will be recruited from the İstanbul Physical Therapy and Rehabilitation Training and Research Hospital inpatient clinic. This setting provides access to a consecutive sample of individuals with varying degrees of functional deficits who are undergoing an organized rehabilitation program.

You may qualify if:

  • Voluntary participation in the study
  • Male and female patients aged 18-80
  • History of ischemic or hemorrhagic stroke
  • Functional Ambulation Scale level 3 or higher
  • Standardized mini mental test ≥ 24
  • Individuals who agree to participate in the study.

You may not qualify if:

  • History of musculoskeletal surgery within the last year
  • Trauma, fracture, dislocation, or tumor within the last year
  • Vestibular system disorder
  • Additional neurological disease that may affect balance (Parkinson's Disease, Multiple Sclerosis, vestibular system disorder)
  • Other rheumatological or psychiatric diseases
  • Chronic decompensated cardiac, renal, or hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Physical Therapy and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Pin TW, Winser SJ, Chan WLS, Chau B, Ng S, Wong T, Mak M, Pang M. Association between fear of falling and falls following acute and chronic stroke: a systematic review with meta-analysis. J Rehabil Med. 2024 Jan 16;56:jrm18650. doi: 10.2340/jrm.v56.18650.

  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

  • Batchelor FA, Mackintosh SF, Said CM, Hill KD. Falls after stroke. Int J Stroke. 2012 Aug;7(6):482-90. doi: 10.1111/j.1747-4949.2012.00796.x. Epub 2012 Apr 12.

MeSH Terms

Conditions

StrokeKinesiophobia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

November 15, 2025

Primary Completion

December 15, 2025

Study Completion

December 31, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD), including all demographic, clinical, and primary/secondary outcome measures will be shared with qualified researchers. The sharing period will commence 6 months after article publication and conclude 1 year thereafter. Data access requests must be accompanied by a methodologically sound proposal and will be granted upon the corresponding author's approval and the execution of a Data Use Agreement (DUA) to strictly ensure confidentiality and adherence to ethical guidelines.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 6 months and ending 1 year following article publication.
Access Criteria
Qualified researchers who present a methodologically robust proposal aimed at fulfilling the objectives of the approved project.

Locations