- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
62
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Lütfiye AKKURT, Assistant Professor
- Numero di telefono: 1446 0 (274) 260 00 43
- Email: lutfiye.akkurt@ksbu.edu.tr
Luoghi di studio
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Kütahya
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Kütahya, Kütahya, Turchia (Türkiye), 43100
- Reclutamento
- Kutahya Health Sciences University
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Contatto:
- Lütfiye AKKURT, Asst.Prof.
- Numero di telefono: 1446 +90 (274) 260 00 43
- Email: lutfiye.akkurt@ksbu.edu.tr
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Contatto:
- Fatıma YAMAN, Assoc.Prof.
- Numero di telefono: +90 (274) 260 00 43
- Email: fatima.yaman@ksbu.edu.tr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Patients with stroke
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fugl-Meyer Assessment of Upper Extremity
Lasso di tempo: Baseline
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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.
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Baseline
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Brunnstrom Recovery Stages of Upper Extremity and Hand
Lasso di tempo: 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
Lasso di tempo: 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
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Baseline
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Falls Efficacy Scale-International
Lasso di tempo: Baseline
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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.
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Baseline
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Timed Up and Go Test
Lasso di tempo: Baseline
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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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Ultrasound Shoulder Pathology Rating Scale
Lasso di tempo: Baseline
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Ali Çağtay DAYI, MD, Kutahya Health Sciences University
- Investigatore principale: Güllü AYDIN-YAĞCIOĞLU, Assoc.Prof., University of Health Sciences/ Gulhane Campus
- Investigatore principale: Fatıma YAMAN, Assoc.Prof., Kutahya Health Sciences University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
20 marzo 2026
Completamento primario (Stimato)
25 ottobre 2026
Completamento dello studio (Stimato)
15 novembre 2026
Date di iscrizione allo studio
Primo inviato
13 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
26 aprile 2026
Primo Inserito (Effettivo)
30 aprile 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 agosto 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026/03-32
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .