跳至主要内容
临床试验/NCT03045432
NCT03045432已完成不适用

Passive Range of Motion and Position Training for Stroke Patients With Hemiplegia to Prevent Shoulder Injury or Pain- Ultrasonographic Study

Chang Gung Memorial Hospital0 个研究点目标入组 104 人开始时间: 2007年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
主要终点
the change from baseline on hemiplegic upper extremity sonography

研究概览

简要总结

Several factors associated with the hemiplegic shoulder pain after stroke includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. In this study, the investigators aim to usie high frequency ultrasound to evaluate the relationship between stroke patients with poor shoulder motor function and shoulder tendon injury. Also, assumed that performing passive range of motion and positioning training might prevent tendon injury of shoulder and hemiplegic shoulder pain in either acute or chronic stage of stroke.

详细描述

Hemiplegic shoulder pain is a common complication. Several factors associated with the hemiplegic shoulder pain includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. Flaccidity has a positive association with soft tissue injury or tendon injury of the shoulder.

In the preliminary study, base on the sonography results, it is found that the possibility of getting tendon injury or inflammation on the affected shoulder joint is higher in the group of patients who were with worse motor functions during the rehabilitation in hospital.

In this study, one hundred acute stroke patients with hemipelgia will be enrolled. And those participants would be separated into 2 groups: control group (Brunnstrom stage IV-VI) and experimental group (Brunnstrom stage I-III). Clinical characteristics and physical findings will be recorded on the admission date. During the process, the investigators will use high frequency (5-12 MHz) musculoskeletal ultrasound to evaluate those tendons around bilateral shoulder joints on the admission date and at 2 weeks later. In the first year after stroke, half patients in those 2 groups will perform positioning training and passive range of motion for affected shoulder either during hospitalization or after being discharged. Then, the investigators will execute physical examination and use high frequency ultrasound to evaluate those tendons around bilateral shoulder joints of the participants twice after 6 months and 12 months. Then, the investigators will discuss the incidences of shoulder tendon injury after receiving rehabilitation program according to ultra-sonographic findings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • stroke with hemiplegia
  • age between 18-80

排除标准

  • recurrent stoke patient
  • previous history of shoulder pain, any injuries and operation in shoulder joint, frozen shoulder, tendinitis in shoulder joint,
  • any other systemic neuromuscular disease
  • cognition or language impairment leading to communication difficulty

结局指标

主要结局

the change from baseline on hemiplegic upper extremity sonography

时间窗: baseline (before intervention), changes from baseline sonography results at one week before being discharged and at six month after.

A doctor will use a high frequency(5-12 MHz) sonography examination machine(Terason t300, Teratech Co., USA) as the evaluation tool of this study. The target muscles and structures around affected shoulder includes biceps, supraspinatus, infraspinatus, subscapularis, sub-deltoid bursa and ACJ.

次要结局

  • Modified Ashworth scale for level of spasticity of affected arm(baseline (before intervention), changes from baseline level of spasticity at one week before being discharged and at six month after.)
  • Brunnstrom motor recovery stage for motor ability(baseline (before intervention), changes from baseline Brunnstrom stage at one week before being discharged and at six month after.)
  • Range of motion(baseline (before intervention), changes from baseline range of motions at one week before being discharged and at six month after.)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

相似试验