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临床试验/NCT07675759
NCT07675759进行中(未招募)不适用

The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
80
试验地点
1
主要终点
Acromiohumeral distance

研究概览

简要总结

Stroke is a leading cause of long-term disability worldwide. During the early stage of recovery after cerebral infarction, reduced muscle tone and muscle weakness in the affected upper limb may lead to shoulder instability and shoulder subluxation, which can subsequently result in pain, limited range of motion, increased spasticity, and impaired upper extremity function. Early prevention of shoulder subluxation is therefore an important component of stroke rehabilitation.Proper positioning and external support of the affected upper limb may help maintain normal shoulder alignment, reduce gravitational traction on the shoulder joint, and prevent secondary complications. However, conventional sling-type shoulder supports have limitations in maintaining appropriate upper-limb positioning during different activities and postures.

This randomized controlled trial aims to evaluate the effectiveness and safety of a novel assistive device designed to prevent shoulder subluxation in patients with post-stroke hemiplegia. Eighty participants with first-ever cerebral infarction will be randomly assigned to either the intervention group, receiving the novel assistive device in addition to standard rehabilitation, or the control group, receiving a conventional sling shoulder support and standard rehabilitation. The primary outcome is acromiohumeral distance measured by ultrasonography. Secondary outcomes include muscle spasticity assessed by the Modified Ashworth Scale, joint range of motion, and upper extremity motor function. The findings of this study may provide evidence for the early prevention of shoulder subluxation and improve rehabilitation outcomes in patients with stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of stroke with unilateral hemiplegia;
  • First-ever stroke;
  • Patient and/or legal guardian has been informed about the study and provides written informed consent;
  • Clinically stable condition.

排除标准

  • 1. Severe cognitive impairment;
  • Malignant tumors;
  • Multiple organ failure;
  • Hemiplegia, joint contracture, muscle spasticity, shoulder subluxation, or neurological dysfunction caused by other etiologies.

结局指标

主要结局

Acromiohumeral distance

时间窗: Baseline and up to 3 weeks

The shortest vertical distance between the inferior border of the acromion and the superior aspect of the humeral head, measured by ultrasonography or/and X-ray to evaluate shoulder subluxation.

次要结局

  • Muscle tone of biceps brachii, flexor digitorum superficialis, and flexor digitorum profundus(Baseline and up to 3 weeks)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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