NCT07847827

Brief Summary

The aim of this study is to evaluate the relationship between fear of falling and motor recovery, stroke duration, trunk control, and balance in stroke patients.

Trial Health

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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
8mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

September 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Fear of FallingMotor RecoveryStrokeTrunk ControlBalance

Outcome Measures

Primary Outcomes (5)

  • The Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a 30-point scale comprising 16 items across 11 categories used to screen for cognitive impairment in stroke and other neurological conditions, where a score of 26 or above indicates normal cognitive function.

    Baseline

  • Brunnstrom Recovery Stages of Upper and Lower Extremity

    The Brunnstrom recovery stages are a staging system that shows the motor recovery in patients with stroke. The Brunnstrom Recovery Stages of Upper and Lower Extremity of six stages. Higher stages indicate better motor function.

    Baseline

  • Falls Efficacy Scale-International (FES-I)

    The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned). Total score is between 16 and 64 points. Lower scores mean a better outcome.

    Baseline

  • Trunk Impairment Scale (TIS)

    The Trunk Impairment Scale (TIS) evaluates post-stroke trunk control across three subscales (static sitting balance, dynamic sitting balance, and coordination) with a maximum total score of 23, where higher scores reflect better trunk function.

    Baseline

  • Tinetti Performance Oriented Mobility Assessment (POMA) - Balance

    The Tinetti Performance Oriented Mobility Assessment (POMA) balance subscale comprises 9 items with a total score of 16, where higher scores indicate better balance performance.

    Baseline

Study Arms (1)

Post-stroke patients

Individuals aged 18 and older diagnosed with stroke, who have a history of at least one fall, are able to walk 10 meters independently or with an assistive device, and can understand and follow simple instructions.

Eligibility Criteria

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

Stroke patients

You may qualify if:

  • Having a diagnosis of stroke
  • Aged ≥ 18 years old
  • History of at least one fall
  • Ability to walk 10 meters independently or with an assistive device
  • Ability to understand and follow simple instructions

You may not qualify if:

  • Having another neurological disease (except for stroke)
  • Having a surgery upper or lower extremity in the last 6 months
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kütahya City Hospital Yoncalı Physical Therapy and Rehabilitation Location

Kütahya, Kütahya, (552) 266-8356, Turkey (Türkiye)

Location

Kütahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mine PEKESEN KURTÇA, PT, PhD, Assistant Professor

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR
  • Seda Nur KEMER, PT, PhD, Lecturer

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR
  • Barış YENEN, MD, Assistant Professor

    Kütahya Health Sciences University

    PRINCIPAL INVESTIGATOR
  • Mustafa ÇETİNER, MD, Associate Professor

    Kütahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lütfiye AKKURT, PT, PhD, Assistant Professor

CONTACT

Lütfiye AKKURT, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 29, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

May 3, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations