StrokeNCT07107295
Thoracolumbar Fascia Thickness in Chronic Stroke Patients
An observational study of Stroke, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of this study was to examine the thoracolumbar fascia thickness in chronic stroke patients using objective methods and to reveal the relationship of this flexibility with balance, trunk control, trunk flexibility, functional independence and other relevant clinical parameters. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to May 2026
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic stroke patients between the ages of 40 and 70 who are receiving routine treatment at a Private University Hospital and healthy individuals with similar demographic characteristics will be included in the study.
Who may be able to join
- Being between 40 and 70 years old.
- Being diagnosed with a stroke by a neurologist.
- Scoring above 21 on the Montreal Cognitive Assessment Scale.
- Scoring between 0 and 3 on the Modified Rankin Scale.
- Being at least 6 months past the stroke
Who cannot join
- Inability to communicate verbally
- Individuals with severe visual impairment, neurological disorders in addition to stroke, and/or congestive heart failure
- Patients in whom exercise is not recommended.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University
Ankara
About this study
Official title: Investigation of Thoracolumbar Fascia Thickness and Its Relationship With Balance, Trunk Control, Trunk Flexibility, and Functional Independence in Chronic Stroke Patients
The main objective of this study was to examine the thoracolumbar fascia thickness in chronic stroke patients using objective methods and to reveal the relationship of this flexibility with balance, trunk control, trunk flexibility, functional independence and other relevant clinical parameters. Demographic information will be recorded and evaluated. Thoracolumbar fascia thickness will be assessed for individuals in both groups using ultrasonography, trunk flexibility using the Sit-and-Reach test, trunk function using the Trunk Impairment Scale, balance using the Functional Reach Test and the Timed Up and Go test, and functional independence using the Functional Independence Scale.
- Conditions
- Stroke
- 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 |
|---|---|---|
| Study Group | Chronic Stroke Patients | |
| Control Group | Healthy individuals with similar demographic characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Assessment
In this study, ultrasonography will be used to assess the thickness of the thoracolumbar fascia in participants. Participants will be assessed in a comfortable prone position. A physical therapist trained in musculoskeletal ultrasonography will measure the thickness of the thoracolumbar fascia at standard anatomical landmarks. During measurements, care will be taken to ensure the probe is placed perpendicularly and steadily against the muscle tissue, and the images will be optimized and recorded to ensure accurate measurement of muscle thickness. Data obtained will be expressed in millimeters and recorded along with the participants' age, gender, and other demographic information.
Measured: Baseline
Sit-and-Reach Test
This study will be used to assess the flexibility of participants' hamstrings and lumbar extensors. This test is a standardized assessment method that measures how far a person can reach in a seated position with their legs straight, typically using a flexibility box or tape measure. Participants will be asked to sit with their legs straight and lean forward, with their feet resting on the measuring box or wall, without bending their knees. They will be asked to touch their toes as far forward as possible. The farthest point they reach will be recorded in centimeters. The test will be repeated twice, and the best performance will be considered. The resulting values will be used in analyses as an indicator of participants' trunk and lower extremity flexibility levels.
Measured: Baseline
Functional Reach Test
This test is a simple and reliable method for measuring static balance, measuring the maximum distance in centimeters a person can extend their arm forward while standing. The participant is asked to stand parallel to a wall, make a fist with their arm flexed 90 degrees at shoulder height, and reach forward as far as possible without losing their balance or lifting their feet off the ground. The distance between the initial toe position and the maximum reach position is recorded. The test will be repeated three times, and the best performances will be evaluated.
Measured: Baseline
Timed up Go Test
The test assesses functional mobility and balance. The participant rises from a chair, walks 3 meters, turns, walks back to the chair, and sits down. The duration of this activity is recorded with a stopwatch. The test can be performed with the individual's usual assistive devices to ensure safety. Multiple attempts are usually required to ensure optimal performance.
Measured: Baseline
Trunk Impairment Scale
This scale consists of three main sections: static sitting balance, dynamic sitting balance, and trunk coordination. The TIS, which contains 17 items in total, has a maximum score of 23, with higher scores indicating greater trunk control and mobility. The assessment will be conducted by a qualified physiotherapist in accordance with established standard procedures. The results obtained from the scale will be used in statistical analyses as an objective indicator of participants' trunk performance and will be an important data source for determining relationships with other functional parameters.
Measured: Baseline
Functional Independence Measure
The test will be used to assess participants' levels of independence in activities of daily living and their care needs.Each item is scored from 1 (complete dependence) to 7 (complete independence), and the total score ranges from 18 to 126. Higher FIM scores indicate greater functional independence.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Aug 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Seçkinoğulları Korkusuz, Ankara University
- Investigators
- Süleyman Korkusuz, PhD, Study chair, Atılım UniversityBüşra Seçkinoğulları Korkusuz, PhD, Principal investigator, Ankara UniversityAyşenur Özcan, MSc, Study chair, Çankırı Karatekin UniversityAli Mert Özcan, MSc, Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107295
- Sponsor's protocol ID
- E-59394181-604.01-114825
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
PubMed 15137564Yerli S, Yinanc SB, Yagci G, Erbahceci F, Ozcakar L. Thoracolumbar fascia and chronic low back pain in idiopathic lumbar scoliosis: an ultrasonographic study. Eur Spine J. 2024 Jun;33(6):2469-2475. doi: 10.1007/s00586-024-08266-x. Epub 2024 Apr 23.
PubMed 38653872
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Thoracolumbar Fascia Thickness and Its Relationship With Balance, Trunk Control, Trunk Flexibility, and Functional Independence in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT07107295
- Acronym / sponsor ID
- E-59394181-604.01-114825
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 Aug 2025 (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 main objective of this study was to examine the thoracolumbar fascia thickness in chronic stroke patients using objective methods and to reveal the relationship of this flexibility with balance, trunk control, trunk flexibility, functional independence and other relevant clinical parameters. Demographic information will be recorded and evaluated. Thoracolumbar fascia thickness will be assessed for individuals in both groups using ultrasonography, trunk flexibility using the Sit-and-Reach test, trunk function using the Trunk Impairment Scale, balance using the Functional Reach Test and the Timed Up and Go test, and functional independence using the Functional Independence Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Chronic Stroke Patients |
| Control Group | – | –Healthy individuals with similar demographic characteristics |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic stroke patients between the ages of 40 and 70 who are receiving routine treatment at a Private University Hospital and healthy individuals with similar demographic characteristics will be included in the study.
Key inclusion criteria (5 listed)
- Being between 40 and 70 years old.
- Being diagnosed with a stroke by a neurologist.
- Scoring above 21 on the Montreal Cognitive Assessment Scale.
- Scoring between 0 and 3 on the Modified Rankin Scale.
- Being at least 6 months past the stroke
Key exclusion criteria (3 listed)
- Inability to communicate verbally
- Individuals with severe visual impairment, neurological disorders in addition to stroke, and/or congestive heart failure
- Patients in whom exercise is not recommended.
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
Ultrasonographic Assessment
Time frame: Baseline
In this study, ultrasonography will be used to assess the thickness of the thoracolumbar fascia in participants. Participants will be assessed in a comfortable prone position. A physical therapist trained in musculoskeletal ultrasonography will measure the thickness of the thoracolumbar fascia at standard anatomical landmarks. During measurements, care will be taken to ensure the probe is placed perpendicularly and steadily against the muscle tissue, and the images will be optimized and recorded to ensure accurate measurement of muscle thickness. Data obtained will be expressed in millimeters and recorded along with the participants' age, gender, and other demographic information.
Sit-and-Reach Test
Time frame: Baseline
This study will be used to assess the flexibility of participants' hamstrings and lumbar extensors. This test is a standardized assessment method that measures how far a person can reach in a seated position with their legs straight, typically using a flexibility box or tape measure. Participants will be asked to sit with their legs straight and lean forward, with their feet resting on the measuring box or wall, without bending their knees. They will be asked to touch their toes as far forward as possible. The farthest point they reach will be recorded in centimeters. The test will be repeated twice, and the best performance will be considered. The resulting values will be used in analyses as an indicator of participants' trunk and lower extremity flexibility levels.
Functional Reach Test
Time frame: Baseline
This test is a simple and reliable method for measuring static balance, measuring the maximum distance in centimeters a person can extend their arm forward while standing. The participant is asked to stand parallel to a wall, make a fist with their arm flexed 90 degrees at shoulder height, and reach forward as far as possible without losing their balance or lifting their feet off the ground. The distance between the initial toe position and the maximum reach position is recorded. The test will be repeated three times, and the best performances will be evaluated.
Timed up Go Test
Time frame: Baseline
The test assesses functional mobility and balance. The participant rises from a chair, walks 3 meters, turns, walks back to the chair, and sits down. The duration of this activity is recorded with a stopwatch. The test can be performed with the individual's usual assistive devices to ensure safety. Multiple attempts are usually required to ensure optimal performance.
Trunk Impairment Scale
Time frame: Baseline
This scale consists of three main sections: static sitting balance, dynamic sitting balance, and trunk coordination. The TIS, which contains 17 items in total, has a maximum score of 23, with higher scores indicating greater trunk control and mobility. The assessment will be conducted by a qualified physiotherapist in accordance with established standard procedures. The results obtained from the scale will be used in statistical analyses as an objective indicator of participants' trunk performance and will be an important data source for determining relationships with other functional parameters.
Functional Independence Measure
Time frame: Baseline
The test will be used to assess participants' levels of independence in activities of daily living and their care needs.Each item is scored from 1 (complete dependence) to 7 (complete independence), and the total score ranges from 18 to 126. Higher FIM scores indicate greater functional independence.
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 24 Mar 2026.
- Results publication: PubMed 15137564Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
- Results publication: PubMed 38653872Yerli S, Yinanc SB, Yagci G, Erbahceci F, Ozcakar L. Thoracolumbar fascia and chronic low back pain in idiopathic lumbar scoliosis: an ultrasonographic study. Eur Spine J. 2024 Jun;33(6):2469-2475. doi: 10.1007/s00586-024-08266-x. Epub 2024 Apr 23.
- Individual participant dataSharing planned: No
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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.
Süleyman Korkusuz, PhD study chair
Atılım University
Büşra Seçkinoğulları Korkusuz, PhD principal investigator
Ankara University
Ayşenur Özcan, MSc study chair
Çankırı Karatekin University
1 site 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 Ankara University at 1 site 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Büşra Seçkinoğulları Korkusuz, PhD (+905442436914, bskorkusuz@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Assessment (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07107295, which also lists 2 linked publications.
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 24 Mar 2026.