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- Klinische proef NCT07559006
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
11 augustus 2026 bijgewerkt door: Lütfiye AKKURT, MSc, Kutahya Health Sciences University
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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
62
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Lütfiye AKKURT, Assistant Professor
- Telefoonnummer: 1446 0 (274) 260 00 43
- E-mail: lutfiye.akkurt@ksbu.edu.tr
Studie Locaties
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Kütahya
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Kütahya, Kütahya, Turkije (Türkiye), 43100
- Werving
- Kutahya Health Sciences University
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Contact:
- Lütfiye AKKURT, Asst.Prof.
- Telefoonnummer: 1446 +90 (274) 260 00 43
- E-mail: lutfiye.akkurt@ksbu.edu.tr
-
Contact:
- Fatıma YAMAN, Assoc.Prof.
- Telefoonnummer: +90 (274) 260 00 43
- E-mail: fatima.yaman@ksbu.edu.tr
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Patients with stroke
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having another neurological disease (except for stroke
- Having communication deficits or neglect
- Having a surgery upper or lower extremity in the last 6 months
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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With Hemiplegic Shoulder Pain in Stroke Patients
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Without Hemiplegic Shoulder Pain in Stroke Patients
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Fugl-Meyer Assessment of Upper Extremity
Tijdsspanne: 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.
|
Baseline
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Brunnstrom Recovery Stages of Upper Extremity and Hand
Tijdsspanne: Baseline
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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.
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Baseline
|
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Trunk Impairment Scale
Tijdsspanne: Baseline
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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
|
Baseline
|
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Falls Efficacy Scale-International
Tijdsspanne: 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.
|
Baseline
|
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Timed Up and Go Test
Tijdsspanne: 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.
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Baseline
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Barthel Index
Tijdsspanne: Baseline
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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.
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Baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Ultrasound Shoulder Pathology Rating Scale
Tijdsspanne: Baseline
|
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.
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Baseline
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Ultrasound Assessment of Acromiohumeral Distance
Tijdsspanne: Baseline
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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.
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Baseline
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Shoulder Pain and Disability Index
Tijdsspanne: Baseline
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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.
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Baseline
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Visual Analog Scale
Tijdsspanne: Baseline
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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
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Baseline
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Pressure Pain Threshold
Tijdsspanne: Baseline
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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.
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Baseline
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Ultrasound Assessment of Supraspinatus Tendon Thickness
Tijdsspanne: Baseline
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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)
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Baseline
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Ali Çağtay DAYI, MD, Kutahya Health Sciences University
- Hoofdonderzoeker: Güllü AYDIN-YAĞCIOĞLU, Assoc.Prof., University of Health Sciences/ Gulhane Campus
- Hoofdonderzoeker: Fatıma YAMAN, Assoc.Prof., Kutahya Health Sciences University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
20 maart 2026
Primaire voltooiing (Geschat)
25 oktober 2026
Studie voltooiing (Geschat)
15 november 2026
Studieregistratiedata
Eerst ingediend
13 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 april 2026
Eerst geplaatst (Werkelijk)
30 april 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
11 augustus 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026/03-32
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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