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 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Descripción detallada
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 de estudio
Tipo de estudio
De observación
Inscripción (Estimado)
Inscripción
62
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Lütfiye AKKURT, Assistant Professor
- Número de teléfono: 1446 0 (274) 260 00 43
- Correo electrónico: lutfiye.akkurt@ksbu.edu.tr
Ubicaciones de estudio
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Kütahya
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Kütahya, Kütahya, Turquía (Türkiye), 43100
- Reclutamiento
- Kutahya Health Sciences University
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Contacto:
- Lütfiye AKKURT, Asst.Prof.
- Número de teléfono: 1446 +90 (274) 260 00 43
- Correo electrónico: lutfiye.akkurt@ksbu.edu.tr
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Contacto:
- Fatıma YAMAN, Assoc.Prof.
- Número de teléfono: +90 (274) 260 00 43
- Correo electrónico: fatima.yaman@ksbu.edu.tr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients with stroke
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
2
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fugl-Meyer Assessment of Upper Extremity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ultrasound Shoulder Pathology Rating Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Ali Çağtay DAYI, MD, Kutahya Health Sciences University
- Investigador principal: Güllü AYDIN-YAĞCIOĞLU, Assoc.Prof., University of Health Sciences/ Gulhane Campus
- Investigador principal: Fatıma YAMAN, Assoc.Prof., Kutahya Health Sciences University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
20 de marzo de 2026
Finalización primaria (Estimado)
Finalización primaria
25 de octubre de 2026
Finalización del estudio (Estimado)
Finalización del estudio
15 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
13 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
26 de abril de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
11 de agosto de 2026
Última verificación
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2026/03-32
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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