HemiplegiaNCT07159178
The Effect of Shoulder Problems on Balance in Hemiplegic Patients
An observational study of Hemiplegia and Stroke, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Shoulder problems are among the most common complications in hemiplegic patients and may impair shoulder biomechanics, negatively affecting mobility, transfers, and self-care. This study aims to investigate whether shoulder problems influence balance in hemiplegic patients after stroke. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hemiplegia, Stroke
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2025to 7 Nov 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of hemiplegic patients aged 40 to 80 years who experienced a first-ever stroke. Participants were recruited from [insert hospital/clinic name, e.g., Istanbul Aydın University affiliated hospitals/outpatient clinics]. Eligible patients had stable vital signs, adequate cognitive function (MMSE ≥ 24), and the ability to read and write. Patients were divided into subgroups according to the presence or absence of shoulder problems
Who may be able to join
- Voluntary participation with signed informed consent Ability to read and write Age between 40 and 80 years First-ever stroke diagnosis Stable vital signs
Who cannot join
- Diagnosis of any neurological or psychiatric disorder other than stroke Presence of visual or speech impairments History of more than one stroke
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
İstanbul Aydın Unıversity
Istanbul, KÜÇÜKÇEKMECE, 34295
About this study
Official title: Investigation of the Effect of Shoulder Problems on Balance in Patients With Hemiplegia After Stroke
Shoulder problems are among the most common complications in hemiplegic patients and may impair shoulder biomechanics, negatively affecting mobility, transfers, and self-care. This study aims to investigate whether shoulder problems influence balance in hemiplegic patients after stroke. Patients with a first-ever stroke diagnosis, sufficient cognitive function (Mini Mental State Examination score ≥24), no visual impairments, and aged between 40-75 years were included. Hemiplegic patients with shoulder pain formed the first group, while those without shoulder pain formed the second group. Shoulder pain was assessed using the Visual Analog Scale (VAS), shoulder range of motion with the Senso4Motion device, and balance level with both the Berg Balance Scale and Senso4Motion.
Read the detailed description
Hemiplegia is one of the most frequent clinical outcomes after stroke and is commonly accompanied by shoulder problems, which are a major cause of impaired biomechanics. Shoulder function plays a key role in transfers, maintaining postural stability during ambulation, and ensuring effective hand and self-care functions. Impaired shoulder biomechanics may cause a feeling of insecurity, abnormal gait disturbances, and balance deficits.
The primary objective of this study is to evaluate the effect of shoulder problems on balance in hemiplegic patients. Inclusion criteria were: first-ever diagnosis of stroke, Mini Mental State Examination score ≥24, voluntary participation, literacy, absence of visual impairment, and age between 40-75 years. Participants signed informed consent forms and completed a demographic data form including sex, age, height, weight, education level, medical and family history, smoking status, other comorbidities, affected side, and duration of hemiplegia.
Hemiplegic patients were divided into two groups: those with shoulder pain and those without. Shoulder pain was assessed using the Visual Analog Scale (VAS). Shoulder joint range of motion was measured with the Senso4Motion device. Balance performance was evaluated using the Berg Balance Scale and the Senso4Motion system. By comparing patients with and without shoulder pain, this study aims to clarify the impact of shoulder problems on post-stroke balance, thereby contributing to rehabilitation strategies and improving functional outcomes
- Conditions
- Hemiplegia, Stroke
- Keywords
- Hemiplegia, Stroke, Shoulder Pain, Balance, postural control
- Medical subject headings
- Hemiplegia, 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 |
|---|---|---|
| Hemiplegic Patients With and Without Shoulder Pain | This group includes hemiplegic patients after stroke. Participants were divided into two subgroups according to the presence or absence of shoulder pain. Assessments included pain, balance, and shoulder joint range of motion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain (Visual Analog Scale - VAS)
Shoulder pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
Measured: At baseline (single assessment)
Secondary outcomes (2)
Berg Balance Scale
Balance performance will be evaluated using the Berg Balance Scale (BBS). Scores range from 0 to 56, with higher scores indicating better balance ability.
Measured: at baseline (single assesment)
Eularia Health - Eularia Lab
Balance performance will also be assessed using the Eularia Health - Euralia Lab system, which provides objective measurements of postural stability, movement parameters, and dynamic balance control.
Measured: at baseline (single assesment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start7 Sep 2025 (estimated)
- Primary completion7 Oct 2025 (estimated)
- Study completion7 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDA SALGUT, Istanbul Aydın University
- Investigators
- GÖKHAN ÖZKOÇAK, M.D., Study chair, İSTANBUL AYDIN UNIVERSITYİBRAHİM HALİL URAL, M.D, Study chair, İstanbul Beykent UnıversıtyARZU DİNÇ YAVAŞ, M.D, Study chair, Istanbul Aydın Universityeda salgut, PT, Principal investigator, İSTANBUL AYDIN UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159178
- Sponsor's protocol ID
- IstanbuIAU
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Shoulder Problems on Balance in Patients With Hemiplegia After Stroke
- ClinicalTrials.gov ID
- NCT07159178
- Acronym / sponsor ID
- IstanbuIAU
- Conditions
- Hemiplegia, Stroke
- Keywords
- Hemiplegia, Stroke, Shoulder Pain, Balance, postural control
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 7 Sep 2025 (estimated)
- Primary completion
- 7 Oct 2025 (estimated)
- Study completion
- 7 Nov 2025 (estimated)
- First posted
- 8 Sep 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.
Shoulder problems are among the most common complications in hemiplegic patients and may impair shoulder biomechanics, negatively affecting mobility, transfers, and self-care. This study aims to investigate whether shoulder problems influence balance in hemiplegic patients after stroke. Patients with a first-ever stroke diagnosis, sufficient cognitive function (Mini Mental State Examination score ≥24), no visual impairments, and aged between 40-75 years were included. Hemiplegic patients with shoulder pain formed the first group, while those without shoulder pain formed the second group. Shoulder pain was assessed using the Visual Analog Scale (VAS), shoulder range of motion with the Senso4Motion device, and balance level with both the Berg Balance Scale and Senso4Motion.
Detailed description
Hemiplegia is one of the most frequent clinical outcomes after stroke and is commonly accompanied by shoulder problems, which are a major cause of impaired biomechanics. Shoulder function plays a key role in transfers, maintaining postural stability during ambulation, and ensuring effective hand and self-care functions. Impaired shoulder biomechanics may cause a feeling of insecurity, abnormal gait disturbances, and balance deficits.
The primary objective of this study is to evaluate the effect of shoulder problems on balance in hemiplegic patients. Inclusion criteria were: first-ever diagnosis of stroke, Mini Mental State Examination score ≥24, voluntary participation, literacy, absence of visual impairment, and age between 40-75 years. Participants signed informed consent forms and completed a demographic data form including sex, age, height, weight, education level, medical and family history, smoking status, other comorbidities, affected side, and duration of hemiplegia.
Hemiplegic patients were divided into two groups: those with shoulder pain and those without. Shoulder pain was assessed using the Visual Analog Scale (VAS). Shoulder joint range of motion was measured with the Senso4Motion device. Balance performance was evaluated using the Berg Balance Scale and the Senso4Motion system. By comparing patients with and without shoulder pain, this study aims to clarify the impact of shoulder problems on post-stroke balance, thereby contributing to rehabilitation strategies and improving functional outcomes
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiplegic Patients With and Without Shoulder Pain | – | –This group includes hemiplegic patients after stroke. Participants were divided into two subgroups according to the presence or absence of shoulder pain. Assessments included pain, balance, and shoulder joint range of motion. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of hemiplegic patients aged 40 to 80 years who experienced a first-ever stroke. Participants were recruited from [insert hospital/clinic name, e.g., Istanbul Aydın University affiliated hospitals/outpatient clinics]. Eligible patients had stable vital signs, adequate cognitive function (MMSE ≥ 24), and the ability to read and write. Patients were divided into subgroups according to the presence or absence of shoulder problems
Key inclusion criteria (1 listed)
- Voluntary participation with signed informed consent Ability to read and write Age between 40 and 80 years First-ever stroke diagnosis Stable vital signs
Key exclusion criteria (1 listed)
- Diagnosis of any neurological or psychiatric disorder other than stroke Presence of visual or speech impairments History of more than one stroke
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
Shoulder Pain (Visual Analog Scale - VAS)
Time frame: At baseline (single assessment)
Shoulder pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
2 secondary outcomes
Berg Balance Scale
Time frame: at baseline (single assesment)
Eularia Health - Eularia Lab
Time frame: at baseline (single assesment)
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 8 Sep 2025.
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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.
GÖKHAN ÖZKOÇAK, M.D. study chair
İSTANBUL AYDIN UNIVERSITY
İBRAHİM HALİL URAL, M.D study chair
İstanbul Beykent Unıversıty
ARZU DİNÇ YAVAŞ, M.D study chair
Istanbul Aydın 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 Hemiplegia and Stroke, run by Istanbul Aydın 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 8 Sep 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?
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?
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?
Shoulder Pain (Visual Analog Scale - VAS) (time frame: At baseline (single assessment)). 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 8 Sep 2025.