StrokeNCT07139665
Subacromial Space in Chronic Stroke Patients
An observational study of Stroke, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the subacromial space, shoulder pain, and shoulder disability in chronic stroke patients. A total of 60 chronic stroke patients aged 40-65 with similar demographic characteristics are planned to be included in this study. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2025to 10 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Stroke Patients
Who may be able to join
- Being between the ages of 40 and 65.
- Scoring 21 or higher on the Montreal Cognitive Assessment Scale (MoCA).
- Being diagnosed with an ischemic or hemorrhagic stroke by a neurologist and having experienced the stroke for at least 6 months (chronic stroke).
- Scoring between 0 and 3 on the Modified Rankin Score.
- Volunteering to participate in the study
Who cannot join
- Difficulty with verbal communication (severe aphasia, cognitive impairment, etc.) that would prevent participation in the study and understanding the test instructions.
- Severe visual or hearing impairment that would affect test administration or safety.
- Having another neurological condition (e.g., Parkinson's disease, Multiple Sclerosis, severe peripheral neuropathy) other than stroke that could affect shoulder function or pain.
- Having a history of shoulder surgery before or after stroke, known rotator cuff tear, shoulder dislocation, severe degenerative joint disease (osteoarthritis), or inflammatory rheumatic disease (e.g., rheumatoid arthritis).
- Congestive heart failure, uncontrolled hypertension, or other serious cardiopulmonary disease that would preclude physical assessment or have exercise/positioning limitations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Subacromial Space, Shoulder Pain, and Shoulder Disability Levels in Chronic Stroke Patients
This study aims to examine the subacromial space, shoulder pain, and shoulder disability in chronic stroke patients. A total of 60 chronic stroke patients aged 40-65 with similar demographic characteristics are planned to be included in this study. Participants will be selected voluntarily from among chronic stroke patients presenting for routine examination and follow-up at the Neurology Outpatient Clinic of Başkent University Hospital and meeting the appropriate inclusion criteria. Detailed demographic information (age, gender, stroke duration, affected side, etc.) will be recorded for all individuals included in the study.
Read the detailed description
During the clinical assessment process, the subacromial space distance between the hemiplegic (affected) and healthy sides of the participants will be compared, and shoulder pain levels and shoulder disability levels will be examined. In this context, the subacromial space distance in the shoulder joint will be measured objectively using ultrasonography according to standard protocols. The severity of shoulder pain experienced by participants will be assessed subjectively using a Visual Analog Scale (VAS). Shoulder-related functional limitations and disability levels will be determined using a validated questionnaire, such as the Shoulder Pain and Disability Index (SPADI). Based on the data obtained, the relationships between subacromial distance, shoulder pain, and shoulder disability levels will be statistically analyzed. To ensure the statistical power of the study, a sample size target of 85% will be calculated, and additional individuals will be included if necessary to reach the specified sample size.
- Conditions
- Stroke
- Keywords
- Subacromial Space, Shoulder Pain, Shoulder Disability Levels
- Medical subject headings
- Stroke, Shoulder Pain
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 |
|---|---|---|
| Chronic Stroke Patiens | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Evaluation
In this study, ultrasonography will be used to objectively evaluate the subacromial space distance in the shoulder joint in chronic stroke patients.
Measured: Baseline
Shoulder Pain and Disability Index
In this study, the Shoulder Pain and Disability Index will be used to subjectively assess participants' shoulder pain severity and shoulder-related functional limitations. The Shoulder Pain and Disability Index is a widely used, reliable, and valid self-report questionnaire for measuring pain and functional disability in individuals with shoulder problems.
Measured: Baseline
Visual Analog Scale
The Visual Analog Scale is one of the pain rating scales frequently used in epidemiological and clinical studies to measure the intensity or frequency of various symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start25 Aug 2025
- Primary completion20 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Büşra Seçkinoğulları Korkusuz, Ankara University
- Investigators
- Süleyman Korkusuz, PhD, Study chair, Atılım UniversityAli Mert ÖZCAN, MSc, Study chair, Baskent UniversityAyşenur ÖZCAN, MSc, Study chair, Çankırı Karatekin UniversitySevgi İkbali Afşar, Prof. Dr., Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139665
- Sponsor's protocol ID
- bbff9d0fc1ae4783
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tao W, Fu Y, Hai-Xin S, Yan D, Jian-Hua L. The application of sonography in shoulder pain evaluation and injection treatment after stroke: a systematic review. J Phys Ther Sci. 2015 Sep;27(9):3007-10. doi: 10.1589/jpts.27.3007. Epub 2015 Sep 30.
PubMed 26504346Seitz AL, Michener LA. Ultrasonographic measures of subacromial space in patients with rotator cuff disease: A systematic review. J Clin Ultrasound. 2011 Mar-Apr;39(3):146-54. doi: 10.1002/jcu.20783. Epub 2010 Dec 28.
PubMed 21387327Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5.
PubMed 21843839
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Subacromial Space, Shoulder Pain, and Shoulder Disability Levels in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT07139665
- Acronym / sponsor ID
- bbff9d0fc1ae4783
- Conditions
- Stroke
- Keywords
- Subacromial Space, Shoulder Pain, Shoulder Disability Levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 24 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.
This study aims to examine the subacromial space, shoulder pain, and shoulder disability in chronic stroke patients. A total of 60 chronic stroke patients aged 40-65 with similar demographic characteristics are planned to be included in this study. Participants will be selected voluntarily from among chronic stroke patients presenting for routine examination and follow-up at the Neurology Outpatient Clinic of Başkent University Hospital and meeting the appropriate inclusion criteria. Detailed demographic information (age, gender, stroke duration, affected side, etc.) will be recorded for all individuals included in the study.
Detailed description
During the clinical assessment process, the subacromial space distance between the hemiplegic (affected) and healthy sides of the participants will be compared, and shoulder pain levels and shoulder disability levels will be examined. In this context, the subacromial space distance in the shoulder joint will be measured objectively using ultrasonography according to standard protocols. The severity of shoulder pain experienced by participants will be assessed subjectively using a Visual Analog Scale (VAS). Shoulder-related functional limitations and disability levels will be determined using a validated questionnaire, such as the Shoulder Pain and Disability Index (SPADI). Based on the data obtained, the relationships between subacromial distance, shoulder pain, and shoulder disability levels will be statistically analyzed. To ensure the statistical power of the study, a sample size target of 85% will be calculated, and additional individuals will be included if necessary to reach the specified sample size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Stroke Patiens | – | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Stroke Patients
Key inclusion criteria (5 listed)
- Being between the ages of 40 and 65.
- Scoring 21 or higher on the Montreal Cognitive Assessment Scale (MoCA).
- Being diagnosed with an ischemic or hemorrhagic stroke by a neurologist and having experienced the stroke for at least 6 months (chronic stroke).
- Scoring between 0 and 3 on the Modified Rankin Score.
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- Difficulty with verbal communication (severe aphasia, cognitive impairment, etc.) that would prevent participation in the study and understanding the test instructions.
- Severe visual or hearing impairment that would affect test administration or safety.
- Having another neurological condition (e.g., Parkinson's disease, Multiple Sclerosis, severe peripheral neuropathy) other than stroke that could affect shoulder function or pain.
- Having a history of shoulder surgery before or after stroke, known rotator cuff tear, shoulder dislocation, severe degenerative joint disease (osteoarthritis), or inflammatory rheumatic disease (e.g., rheumatoid arthritis).
- Congestive heart failure, uncontrolled hypertension, or other serious cardiopulmonary disease that would preclude physical assessment or have exercise/positioning limitations.
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 Evaluation
Time frame: Baseline
In this study, ultrasonography will be used to objectively evaluate the subacromial space distance in the shoulder joint in chronic stroke patients.
Shoulder Pain and Disability Index
Time frame: Baseline
In this study, the Shoulder Pain and Disability Index will be used to subjectively assess participants' shoulder pain severity and shoulder-related functional limitations. The Shoulder Pain and Disability Index is a widely used, reliable, and valid self-report questionnaire for measuring pain and functional disability in individuals with shoulder problems.
Visual Analog Scale
Time frame: Baseline
The Visual Analog Scale is one of the pain rating scales frequently used in epidemiological and clinical studies to measure the intensity or frequency of various symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 26504346Tao W, Fu Y, Hai-Xin S, Yan D, Jian-Hua L. The application of sonography in shoulder pain evaluation and injection treatment after stroke: a systematic review. J Phys Ther Sci. 2015 Sep;27(9):3007-10. doi: 10.1589/jpts.27.3007. Epub 2015 Sep 30.
- Results publication: PubMed 21387327Seitz AL, Michener LA. Ultrasonographic measures of subacromial space in patients with rotator cuff disease: A systematic review. J Clin Ultrasound. 2011 Mar-Apr;39(3):146-54. doi: 10.1002/jcu.20783. Epub 2010 Dec 28.
- Results publication: PubMed 21843839Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Süleyman Korkusuz, PhD study chair
Atılım University
Ali Mert ÖZCAN, MSc study chair
Baskent 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 5 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: finished, as of the sponsor's last update on 24 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Evaluation (time frame: Baseline). The study lists 3 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 NCT07139665, which also lists 3 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 Nov 2025.