BreEStim for Post-Stroke Motor Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
研究概览
简要总结
The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment after a long-term use.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has post stroke ≥ 6 months , medically stable;
- •Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
- •MAS score ≥ 1, i.e., detectable finger flexor hypertonia;
排除标准
- •Patients with visual deficit/neglect; hearing or cognitive impairment;
- •Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);
- •Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
- •Patients received botulinum toxin injection to the arm/fingers <4 months, or phenol injections < 2 years;
- •Patients with a pacemaker;
- •Women who are pregnant.
研究组 & 干预措施
BreEStim
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.
干预措施: BreEStim (Device)
EStim
EStim is transcutaneous electrical nerve stimulation.
干预措施: EStim (Device)
结局指标
主要结局
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
时间窗: Baseline, after 10 intervention sessions, about 3 weeks
MAS will be performed to check changes of finger flexor spasticity after one session of treatment. The Modified Ashworth scale (MAS) scoring is categorical and ranges from 0 to 4, as follows: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM) 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
次要结局
- Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale(Baseline, after 10 intervention sessions, about 3 weeks)
研究者
Sheng Li
Professor
The University of Texas Health Science Center, Houston