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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 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

62

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Kütahya
      • Kütahya, Kütahya, Turquia (Türkiye), 43100
        • Recrutamento
        • Kutahya Health Sciences University
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

Patients with stroke

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
With Hemiplegic Shoulder Pain in Stroke Patients
Without Hemiplegic Shoulder Pain in Stroke Patients

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Fugl-Meyer Assessment of Upper Extremity
Prazo: 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
Brunnstrom Recovery Stages of Upper Extremity and Hand
Prazo: 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.
Baseline
Trunk Impairment Scale
Prazo: 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
Baseline
Falls Efficacy Scale-International
Prazo: 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
Timed Up and Go Test
Prazo: 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.
Baseline
Barthel Index
Prazo: 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.
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Ultrasound Shoulder Pathology Rating Scale
Prazo: 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.
Baseline
Ultrasound Assessment of Acromiohumeral Distance
Prazo: Baseline
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.
Baseline
Shoulder Pain and Disability Index
Prazo: Baseline
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.
Baseline
Visual Analog Scale
Prazo: Baseline
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
Baseline
Pressure Pain Threshold
Prazo: Baseline
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.
Baseline
Ultrasound Assessment of Supraspinatus Tendon Thickness
Prazo: Baseline
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)
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de março de 2026

Conclusão Primária (Estimado)

25 de outubro de 2026

Conclusão do estudo (Estimado)

15 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

13 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de abril de 2026

Primeira postagem (Real)

30 de abril de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de agosto de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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