StrokeNCT07847827
Fear of Falling in Stroke: Its Relationship With Motor Recovery, Stroke Duration, Trunk Control, and Balance
An observational study of Stroke, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 1 Jun 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- 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
Who cannot join
- Having another neurological disease (except for stroke)
- Having a surgery upper or lower extremity in the last 6 months
- Unwillingness to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lütfiye AKKURT, PT, PhD, Assistant Professor contact
Turkey (Türkiye)2 sites
Kütahya City Hospital Yoncalı Physical Therapy and Rehabilitation Location
Kütahya, Kütahya, (552) 266-8356
Kütahya Health Sciences University
Kütahya, 43100
Lütfiye AKKURT, PT, PhD, Assistant Professor, +90 (274) 260 00 43 ext. 1446, lutfiye.akkurt@ksbu.edu.tr
About this study
Official title: Factors Associated With Fear of Falling in Stroke
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.
Read the detailed description
Fear of falling is a common and disabling complication in stroke patients during the acute, subacute, and chronic stages. This observational study aims to evaluate the relationship between fear of falling and upper/lower extremity motor recovery, time since stroke, trunk control, and balance in post-stroke individuals. The investigators will assess participants using demographic information, fall history, the Montreal Cognitive Assessment, Brunnstrom Staging for upper and lower extremity motor recovery, the Falls Efficacy Scale International, the Trunk Impairment Scale, and the Tinetti Performance Oriented Mobility Assessment. Additionally, the investigators will evaluate whether clinical parameters such as motor recovery, balance and trunk control correlate with the level of fear of falling.
- Conditions
- Stroke
- Keywords
- Fear of Falling, Motor Recovery, Stroke, Trunk Control, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion3 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lütfiye AKKURT, MSc, Kutahya Health Sciences University
- Investigators
- Mine PEKESEN KURTÇA, PT, PhD, Assistant Professor, Principal investigator, Ondokuz Mayıs UniversitySeda Nur KEMER, PT, PhD, Lecturer, Principal investigator, Ondokuz Mayıs UniversityBarış YENEN, MD, Assistant Professor, Principal investigator, Kütahya Health Sciences UniversityMustafa ÇETİNER, MD, Associate Professor, Principal investigator, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847827
- Sponsor's protocol ID
- 2026/10-51
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Fear of Falling in Stroke
- ClinicalTrials.gov ID
- NCT07847827
- Acronym / sponsor ID
- 2026/10-51
- Conditions
- Stroke
- Keywords
- Fear of Falling, Motor Recovery, Stroke, Trunk Control, Balance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 3 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fear of falling is a common and disabling complication in stroke patients during the acute, subacute, and chronic stages. This observational study aims to evaluate the relationship between fear of falling and upper/lower extremity motor recovery, time since stroke, trunk control, and balance in post-stroke individuals. The investigators will assess participants using demographic information, fall history, the Montreal Cognitive Assessment, Brunnstrom Staging for upper and lower extremity motor recovery, the Falls Efficacy Scale International, the Trunk Impairment Scale, and the Tinetti Performance Oriented Mobility Assessment. Additionally, the investigators will evaluate whether clinical parameters such as motor recovery, balance and trunk control correlate with the level of fear of falling.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Having another neurological disease (except for stroke)
- Having a surgery upper or lower extremity in the last 6 months
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Montreal Cognitive Assessment (MoCA)
Time frame: Baseline
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.
Brunnstrom Recovery Stages of Upper and Lower Extremity
Time frame: Baseline
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.
Falls Efficacy Scale-International (FES-I)
Time frame: Baseline
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.
Trunk Impairment Scale (TIS)
Time frame: Baseline
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.
Tinetti Performance Oriented Mobility Assessment (POMA) - Balance
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lütfiye AKKURT, PT, PhD, Assistant Professor contact
Mine PEKESEN KURTÇA, PT, PhD, Assistant Professor principal investigator
Ondokuz Mayıs University
Seda Nur KEMER, PT, PhD, Lecturer principal investigator
Ondokuz Mayıs University
Barış YENEN, MD, Assistant Professor principal investigator
Kütahya Health Sciences University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lütfiye AKKURT, PT, PhD, Assistant Professor (0 (274) 260 00 43 ext. 1446, lutfiye.akkurt@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Montreal Cognitive Assessment (MoCA) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.