Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Soleus MVC
研究概览
简要总结
This study will investigate the clinical, functional and neurophysiological effects of automated mechanical peripheral stimulation (AMPS) via the Gondola device administered to patients with chronic stroke, cerebral palsy and Parkinson's Disease. Results will be collected using standardized outcome measures and a transcranial magnetic stimulation assessment protocol including electrical stimulation and electromyographic recording.
详细描述
The working hypothesis for this pre-post intervention study is that one session of AMPS will increase voluntary motor drive of the plantar-flexors (soleus) muscle. The primary outcome measure will be maximum voluntary contraction (MVC) of the soleus (measured by electromyography, EMG); the secondary outcome will be the MVC of the antagonist muscle, the tibialis anterior. Data will be collected before the first session compared to directly after. The same measures in sham-stimulated and healthy volunteers will serve as controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A blinded evaluator will collect all the demographic (age, gender, time since injury, injury type), clinical and functional data of the participants. The investigator performing transcranial magnetic stimulation assessments will also be blinded.
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
- 是
入选标准
- •age 18 to 80;
- •chronic stroke lesion >6 months after a cerebrovascular accident OR diagnosis of cerebral palsy OR Parkinson's Disease;
- •presence of some degree of motor function in the ankle flexor (Soleus motor power >1);
- •able to ambulate 10 meters without physical assistance.
排除标准
- •medically unstable condition;
- •presence of other concurrent neurological illness;
- •cognitive impairment (Montreal Cognitive Assessment score <23);
- •presence of any potential TMS risk factor: damaged skin at the site of stimulation;
- •presence of an electrically, magnetically or mechanically activated implant, an intracerebral vascular clip, or any other electrically sensitive support system;
- •family history of medication-resistant epilepsy;
- •past history of seizures or unexplained spells of loss of consciousness.
结局指标
主要结局
Change in Soleus MVC
时间窗: pre and post-AMPS (baseline and 2 minutes)
maximum voluntary contraction of the soleus muscle (measured by EMG)
次要结局
- Change in Tibialis anterior MVC(pre and post-AMPS (baseline and 2 minutes))
- Change in 10 meter walk test(pre and post-AMPS (baseline and 2 minutes))
研究者
David Putrino
Director of Rehabilitation Innovation for the Mount Sinai Health System; Associate Professor, Rehabilitation Medicine
Icahn School of Medicine at Mount Sinai