Effect of Radial Shock Waves for the Treatment of Upper Limb Functional Disability in Stroke Sequelae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
This is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the fact that no energy flux will be applied.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan indicating Stroke in the territory of the middle cerebral artery;
- •6 to 24 months after stroke date;
- •Stability observed in clinical medical evaluation
- •Granting of written informed consent to participate in the study
排除标准
- •Individuals with a score lower than 24 on the Mini-mental test;
- •Previously documented strokes
- •Pregnancy
- •Patients treated with botulinum toxin, phenol, alcohol or previous surgeries six months before entering the study
- •Bone diseases, pre-existing joint damage, and deformities affecting the patient in a way to interfere with implementation of the proposed therapy
- •Psycho-affective disorder that prevents adherence
- •Joint pain that occurs within the movement range of therapies
研究组 & 干预措施
Active Radial Shockwave
Every patient will receive 5,000 continuous pulses per treatment session, at 3.5 to 4 bar air pressure (resulting in an energy flux density [EFD] of approximately 0.07 mJ/mm2) and at 15Hz frequency. A total of 4 sessions will be performed.
干预措施: Active Radial Shockwave (Device)
Sham Radial Shockwave
Every patient will receive 5,000 continuous pulses per treatment session, without air pressure (resulting in no EFD) and at 15Hz frequency. A total of 4 sessions will be performed.
干预措施: Sham Radial Shockwave (Device)
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: Change from baseline to 8 weeks
Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.
次要结局
- Jebsen-Taylor Hand Function Test (JTHFT)(Baseline, one and two months)
- Change in fine motor function measured with Finger Tapping (FT)(Baseline, one and two months)
- Purdue Pegboard Test (PPBT)(Baseline, one and two months)
- Medical Research Council scale (MRC)(Baseline, one and two months)
- Robotic kinematic evaluation (RKE)(Baseline, one and two months)
- Pinch strength testing(Baseline, one and two months)
- Visual Analogue Scale (VAS)(Baseline, one and two months)
- Esthesiometry - Von Frey Scale(Baseline, one and two months)
- Fugl-Meyer Assessment(Baseline and two months)
- Hand grip(Baseline, one and two months)
- Corticospinal excitability measures with transcranial magnetic stimulation (TMS)(Baseline, one and two months)
- Upper Limb Modified Ashworth Scale (MAS)(Baseline, one week, two weeks, three weeks, four weeks and two months)
研究者
Marta Imamura
MD PhD
University of Sao Paulo