Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Static Postural Balance
研究概览
简要总结
The purpose of this research study is to examine the efficacy of non-invasive brain stimulation in addition to balance exercise for chronic ankle instability (CAI), a condition that develops following an initial ankle sprain, usually because of loose or unstable ankle joints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should be neurologically sound
- •Subjects should have abilities to maintain a single-leg stance at least for 10 seconds.
- •A history of ankle sprain
- •A history of ankle joint giving ways
- •Current feelings of ankle joint instability
排除标准
- •Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with Transcranial Magnetic Stimulation (TMS), deep brain stimulation for any disorder will be excluded.
- •Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
- •A history of balance or vestibular disorder
- •A history of previous surgeries to the musculoskeletal structures in either limb of the lower extremity
- •A history of a fracture in either limb of the lower extremity requiring realignment
- •A history of acute injuries to the lower extremity joints in the previous 3 months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
- •A history of herniated disc
- •Poorly controlled headache
- •Hypersensitivity to electrical or magnetic stimulation
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
结局指标
主要结局
Static Postural Balance
时间窗: Week 4
Center of Pressure (COP) velocity (cm/s)
Active Motor Threshold (AMT)
时间窗: 4 weeks
The active motor threshold (AMT) was measured by transcranial magnetic stimulation (TMS) using a computation program, Parameter Estimation by Sequential Testing (PEST). AMT was defined as the minimum TMS intensity required to elicit an adequate motor-evoked potential (MEP) in the soleus muscle. A lower AMT reflects greater corticospinal excitability. The unit of measure is Percentage of Maximum Stimulus Output (MSO)
次要结局
- Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)(4 weeks)
- Self-reported Functional Scores(4 weeks)
- Spinal Reflex Excitability(4 weeks)
- Dynamic Postural Control as Measured by the Reach Distance(4 weeks)
- Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop(4 weeks)
研究者
Brian Arwari
Associate Professor
University of Miami