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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

2026年8月11日 更新者: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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

62

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

Patients with stroke

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
With Hemiplegic Shoulder Pain in Stroke Patients
Without Hemiplegic Shoulder Pain in Stroke Patients

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Fugl-Meyer Assessment of Upper Extremity
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Ultrasound Shoulder Pathology Rating Scale
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ali Çağtay DAYI, MD、Kutahya Health Sciences University
  • 首席研究员:Güllü AYDIN-YAĞCIOĞLU, Assoc.Prof.、University of Health Sciences/ Gulhane Campus
  • 首席研究员:Fatıma YAMAN, Assoc.Prof.、Kutahya Health Sciences University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月20日

初级完成 (估计的)

2026年10月25日

研究完成 (估计的)

2026年11月15日

研究注册日期

首次提交

2026年4月13日

首先提交符合 QC 标准的

2026年4月26日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年4月1日

更多信息

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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