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临床试验/NCT07159178
NCT07159178Enrolling By Invitation不适用

Investigation of the Effect of Shoulder Problems on Balance in Patients With Hemiplegia After Stroke

Istanbul Aydın University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Shoulder Pain (Visual Analog Scale - VAS)

研究概览

简要总结

Shoulder problems are among the most common complications in hemiplegic patients and may impair shoulder biomechanics, negatively affecting mobility, transfers, and self-care. This study aims to investigate whether shoulder problems influence balance in hemiplegic patients after stroke. Patients with a first-ever stroke diagnosis, sufficient cognitive function (Mini Mental State Examination score ≥24), no visual impairments, and aged between 40-75 years were included. Hemiplegic patients with shoulder pain formed the first group, while those without shoulder pain formed the second group. Shoulder pain was assessed using the Visual Analog Scale (VAS), shoulder range of motion with the Senso4Motion device, and balance level with both the Berg Balance Scale and Senso4Motion.

详细描述

Hemiplegia is one of the most frequent clinical outcomes after stroke and is commonly accompanied by shoulder problems, which are a major cause of impaired biomechanics. Shoulder function plays a key role in transfers, maintaining postural stability during ambulation, and ensuring effective hand and self-care functions. Impaired shoulder biomechanics may cause a feeling of insecurity, abnormal gait disturbances, and balance deficits.

The primary objective of this study is to evaluate the effect of shoulder problems on balance in hemiplegic patients. Inclusion criteria were: first-ever diagnosis of stroke, Mini Mental State Examination score ≥24, voluntary participation, literacy, absence of visual impairment, and age between 40-75 years. Participants signed informed consent forms and completed a demographic data form including sex, age, height, weight, education level, medical and family history, smoking status, other comorbidities, affected side, and duration of hemiplegia.

Hemiplegic patients were divided into two groups: those with shoulder pain and those without. Shoulder pain was assessed using the Visual Analog Scale (VAS). Shoulder joint range of motion was measured with the Senso4Motion device. Balance performance was evaluated using the Berg Balance Scale and the Senso4Motion system. By comparing patients with and without shoulder pain, this study aims to clarify the impact of shoulder problems on post-stroke balance, thereby contributing to rehabilitation strategies and improving functional outcomes

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntary participation with signed informed consent Ability to read and write Age between 40 and 80 years First-ever stroke diagnosis Stable vital signs

排除标准

  • Diagnosis of any neurological or psychiatric disorder other than stroke Presence of visual or speech impairments History of more than one stroke

结局指标

主要结局

Shoulder Pain (Visual Analog Scale - VAS)

时间窗: At baseline (single assessment)

Shoulder pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain".

次要结局

  • Berg Balance Scale(at baseline (single assesment))
  • Eularia Health - Eularia Lab(at baseline (single assesment))

研究者

发起方
Istanbul Aydın University
申办方类型
Other
责任方
Principal Investigator
主要研究者

EDA SALGUT

principal ınvestigator

Istanbul Aydın University

研究点 (1)

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