Efficacy of Repetitive Peripheral Magnetic Stimulation on Shoulder Subluxation in Subacute Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acromiohumeral interval
研究概览
简要总结
The goal of this clinical trial is to study the efficacy of repetitive peripheral magnetic stimulation (rPMS) on shoulder subluxation in subacute stroke patients. The main questions it aims to answer are Could rPMS reduce shoulder subluxation and improve upper-limb motor recovery in subacute stroke patients?
Researchers will compare real rPMS to sham rPMS to see if rPMS works to improve shoulder subluxation and upper-limb motor recovery in subacute stroke patients.
Participants will:
- Get real rPMS or sham rPMS for 20 minutes, 5 days a week for 2 weeks
- Get conventional rehabilitation program 5 days a week for 2 weeks
- Follow-up at 2-, 4-, 8- and 12-weeks after first day of treatment
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
- Double (Participant, 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
- 否
入选标准
- •Subacute phase (seven days to six months) and first time of stroke patients
- •Shoulder subluxation that measured half of a fingerbreadth or more
- •Meet the criteria for admission to a comprehensive rehabilitation program
- •Medically stable
- •Intact skin on the hemiparetic arm
排除标准
- •Patients with contraindication for magnetic stimulation; cardiac pacemakers, magnetic materials near the intended stimulation site
- •Patients with pregnancy
- •Patients with severe aphasia or severe cognitive impairment
- •Patients with previous shoulder pathology or limit shoulder function before stroke
- •Patients with unstable vital signs
研究组 & 干预措施
real rPMS
Real rPMS was applied to supraspinatus and posterior deltoid muscles for 20 Hz total 2,400 pulses.
干预措施: Peripheral magnetic stimulator (Device)
sham rPMS
sham rPMS was applied to supraspinatus and posterior deltoid muscles with the same coil as real rPMS, but in a position perpendicular to the skin, using intensity for 5% of the maximum output.
干预措施: Peripheral magnetic stimulator (Device)
结局指标
主要结局
Acromiohumeral interval
时间窗: pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment
the shortest distance between two parallel lines drawn from the inferior border of the acromion and the superior border of the humerus head on the anteroposterior shoulder x-ray
次要结局
- Fugl-Meyer assessment of upper extremities (FMA-UE)(pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment)
- Numeric Pain Rating Scale (NRS)(pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment)
- Modified Ashworth Scale (MAS)(pretreatment, 2-, 4-, 8- and 12-weeks after first day of treatment)