StrokeNCT07559006
Effects of Hemiplegic Shoulder Pain on Upper Extremity Motor Function, Trunk Control, Fear of Falling, Mobility and Indepence in Activities of Daily Living in Patients With Stroke
An observational study of Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effects of hemiplegic shoulder pain on upper extremity motor assessment, trunk control, fear of falling, mobility, and functional indepedence patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2026to 15 Nov 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke
Who may be able to join
- Having a diagnosis of stroke
- Aged ≥ 18 years old
- Mini Mental State Test score ≥ 24 points
- Having a shoulder VAS score of 3 points or higher
Who cannot join
- Having another neurological disease (except for stroke
- Having communication deficits or neglect
- Having a surgery upper or lower extremity in the last 6 months
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
Kütahya Health Sciences University
Kütahya, Kütahya, 43100
Lütfiye AKKURT, Asst.Prof., +90 (274) 260 00 43 ext. 1446, lutfiye.akkurt@ksbu.edu.tr
Fatıma YAMAN, Assoc.Prof., +90 (274) 260 00 43, fatima.yaman@ksbu.edu.tr
About this study
Official title: Effects of Hemiplegic Shoulder Pain on Body Structure and Activity in Patients With Stroke
This study aimed to examine the effects of hemiplegic shoulder pain on upper extremity motor assessment, trunk control, fear of falling, mobility, and functional indepedence patients with stroke.
Read the detailed description
The hemiplegic shoulder pain (HSP) in stroke patients is one of the most common complication in acute and subacute stage. Our study consisted of two groups: with and without hemiplegic shoulder pain. The investigators will investigate whether there are differences between the two groups in terms of upper extremity motor assessment, trunk control, fear of falling, mobility, and functional indepedence. Additionally, the investigators will investigate whether there is a correlation between USPRS and other scales (radiologic shoulder assessments and functional outcome measures) in patients with hemiplegic shoulder pain.
- Conditions
- Stroke
- Keywords
- stroke, hemiplegic shoulder pain, trunk control, upper extremity, mobility
- 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 |
|---|---|---|
| With Hemiplegic Shoulder Pain in Stroke Patients | Not described | |
| Without Hemiplegic Shoulder Pain in Stroke Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Upper Extremity
Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. This scale was first proposed by Axel Fugl-Meyer and his colleagues 1975 as a standardized assessment test for post-stroke recovery in their paper titled "The post-stroke hemiplegic patient: A method for evaluation of physical performance". It is now widely used for clinical assessment of motor function. The Fugl-Meyer Assessment of Upper Extremity motor assessments for the upper (maximum score 66 points) is recommended as core measures to be used in every stroke recovery and rehabilitation trial. Total score is between 0 and 66 points. Higher scores mean a better outcome.
Measured: Baseline
Brunnstrom Recovery Stages of Upper Extremity and Hand
The Brunnstrom recovery stages are a staging system that shows the motor recovery in patients with stroke. The Brunnstrom Recovery Stages of Upper Extremity and Hand consist of six stages. Higher stages indicate better motor function.
Measured: Baseline
Trunk Impairment Scale
The Trunk Impairment Scale is a validated clinical tool and measured motor impairment of the trunk after stroke, assessing static/dynamic sitting balance and coordination patient with stroke. Total score is between 0 and 23 points. Higher scores mean a better outcome
Measured: Baseline
Falls Efficacy Scale-International
The Falls Efficacy Scale-International 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
Timed Up and Go Test
The Timed and Up Go is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning. Patients wear their regular footwear and can use a walking aid, if needed. The patient starts in a seated position The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Be sure to document the assistive device used. The total time to perform this task was measured. The TUG score of 13.5 seconds or longer may indicate an increased risk of falls. A score below 13.5 seconds suggests better functional performance.
Measured: Baseline
Barthel Index
The Barthel Index measures the extent to which somebody can function independently and has mobility in their activities of daily living i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care. The Barthel Index is a widely used measure of functional disability. The Barthel Index is a 10-item scale (0-100) assessing functional independence in activities of daily living particularly in rehabilitation settings. A higher score indicates greater independence, with 100 representing full independence and 0 representing total dependency. Higher scores mean a better functional dependence.
Measured: Baseline
Secondary outcomes (6)
Ultrasound Shoulder Pathology Rating Scale
The Ultrasound Shoulder Pathology Rating Scale is a scale based on 5 Ultrasound signs; 3 signs are static and 2 are dynamic. The static tests were greater tuberosity cortical surface irregularity, supraspinatus tendinopathy, and bicipital tendinopathy. The dynamic tests were supraspinatus impingement and subscapularis/biceps/coracoid impingement. A simple ordinal rating scale similar to that used for muscle strength testing was applied to each Ultrasound sign based on the amount of pathology present. The maximum possible score for a shoulder was 20, and the minimum was 0. Higher score indicates a more significant or severe pathology.
Measured: Baseline
Ultrasound Assessment of Acromiohumeral Distance
The patient was sitting down and acromiohumeral joint was visualized while the patient's arm was at the side. Then, an image of the bird's beak was obtained by shifting the ultrasound (7 to 15 MHz, Mindray-UMT 200, NJ, United States) probe laterally in the transverse plane, and the linear distance between the humeral head and the acromion was measured.
Measured: Baseline
Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The test takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. A score of 0 indicates best 100 indicates worst. A higher score shows more disability.
Measured: Baseline
Visual Analog Scale
The visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Total score is between 0 and 10 points. Lower scores mean a better outcome
Measured: Baseline
Pressure Pain Threshold
The Pressure Pain Threshold is a quantitative sensory test measuring the minimum amount of pressure that triggers a painful sensation, used to evaluate tenderness, deep muscular tissue sensitivity. A higher score on a Pressure Pain Threshold test means it takes more pressure to feel pain, indicating lower sensitivity or higher pain tolerance.
Measured: Baseline
Ultrasound Assessment of Supraspinatus Tendon Thickness
For the Supraspinatus Tendon Thickness measure, the participants were seated in an upright position with their feet flat on the floor. Participants were asked to place their tested hand on the ipsilateral iliac crest with the elbow pointed posteriorly (the modified Crass position)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start20 Mar 2026
- Primary completion25 Oct 2026 (estimated)
- Study completion15 Nov 2026 (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
- 62 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
- Ali Çağtay DAYI, MD, Principal investigator, Kütahya Health Sciences UniversityGüllü AYDIN-YAĞCIOĞLU, Assoc.Prof., Principal investigator, University of Health Sciences/ Gulhane CampusFatıma YAMAN, Assoc.Prof., Principal investigator, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559006
- Sponsor's protocol ID
- 2026/03-32
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 13 Aug 2026
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hemiplegic Shoulder Pain on Body Structure and Activity in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07559006
- Acronym / sponsor ID
- 2026/03-32
- Conditions
- Stroke
- Keywords
- stroke, hemiplegic shoulder pain, trunk control, upper extremity, mobility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 30 Apr 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.
This study aimed to examine the effects of hemiplegic shoulder pain on upper extremity motor assessment, trunk control, fear of falling, mobility, and functional indepedence patients with stroke.
Detailed description
The hemiplegic shoulder pain (HSP) in stroke patients is one of the most common complication in acute and subacute stage. Our study consisted of two groups: with and without hemiplegic shoulder pain. The investigators will investigate whether there are differences between the two groups in terms of upper extremity motor assessment, trunk control, fear of falling, mobility, and functional indepedence. Additionally, the investigators will investigate whether there is a correlation between USPRS and other scales (radiologic shoulder assessments and functional outcome measures) in patients with hemiplegic shoulder pain.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Hemiplegic Shoulder Pain in Stroke Patients | – | – |
| Without Hemiplegic Shoulder Pain in Stroke Patients | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke
Key inclusion criteria (4 listed)
- Having a diagnosis of stroke
- Aged ≥ 18 years old
- Mini Mental State Test score ≥ 24 points
- Having a shoulder VAS score of 3 points or higher
Key exclusion criteria (3 listed)
- Having another neurological disease (except for stroke
- Having communication deficits or neglect
- Having a surgery upper or lower extremity in the last 6 months
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
Fugl-Meyer Assessment of Upper Extremity
Time frame: Baseline
Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. This scale was first proposed by Axel Fugl-Meyer and his colleagues 1975 as a standardized assessment test for post-stroke recovery in their paper titled "The post-stroke hemiplegic patient: A method for evaluation of physical performance". It is now widely used for clinical assessment of motor function. The Fugl-Meyer Assessment of Upper Extremity motor assessments for the upper (maximum score 66 points) is recommended as core measures to be used in every stroke recovery and rehabilitation trial. Total score is between 0 and 66 points. Higher scores mean a better outcome.
Brunnstrom Recovery Stages of Upper Extremity and Hand
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 Extremity and Hand consist of six stages. Higher stages indicate better motor function.
Trunk Impairment Scale
Time frame: Baseline
The Trunk Impairment Scale is a validated clinical tool and measured motor impairment of the trunk after stroke, assessing static/dynamic sitting balance and coordination patient with stroke. Total score is between 0 and 23 points. Higher scores mean a better outcome
Falls Efficacy Scale-International
Time frame: Baseline
The Falls Efficacy Scale-International 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.
Timed Up and Go Test
Time frame: Baseline
The Timed and Up Go is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning. Patients wear their regular footwear and can use a walking aid, if needed. The patient starts in a seated position The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Be sure to document the assistive device used. The total time to perform this task was measured. The TUG score of 13.5 seconds or longer may indicate an increased risk of falls. A score below 13.5 seconds suggests better functional performance.
Barthel Index
Time frame: Baseline
The Barthel Index measures the extent to which somebody can function independently and has mobility in their activities of daily living i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care. The Barthel Index is a widely used measure of functional disability. The Barthel Index is a 10-item scale (0-100) assessing functional independence in activities of daily living particularly in rehabilitation settings. A higher score indicates greater independence, with 100 representing full independence and 0 representing total dependency. Higher scores mean a better functional dependence.
6 secondary outcomes
Ultrasound Shoulder Pathology Rating Scale
Time frame: Baseline
Ultrasound Assessment of Acromiohumeral Distance
Time frame: Baseline
Shoulder Pain and Disability Index
Time frame: Baseline
Visual Analog Scale
Time frame: Baseline
Pressure Pain Threshold
Time frame: Baseline
Ultrasound Assessment of Supraspinatus Tendon Thickness
Time frame: Baseline
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 13 Aug 2026.
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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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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.
Ali Çağtay DAYI, MD principal investigator
Kütahya Health Sciences University
Güllü AYDIN-YAĞCIOĞLU, Assoc.Prof. principal investigator
University of Health Sciences/ Gulhane Campus
Fatıma YAMAN, Assoc.Prof. principal investigator
Kütahya Health Sciences 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 Kutahya Health Sciences 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 4 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 13 Aug 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 Lütfiye AKKURT, 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?
Fugl-Meyer Assessment of Upper Extremity (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?
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 13 Aug 2026.