Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change from COP - ML axis
研究概览
简要总结
Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral excitability and movement control in neurological chronic conditions. However, few studies have investigated the effects of tDCS on postural control in patients with Parkinson's disease. This study aims to investigate the effect of bihemispheric tDCS on postural control in people with Parkinson's disease. Participants will be randomized to receive a single session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).
Primary clinical outcome (balance) will be collected before and immediately after tDCS. The data will be collected by a blind examiner to the treatment allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of idiopathic Parkinson's disease present for at least 12 months
- •In clinical follow-up and pharmacological treatment by a responsible physician
- •Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale
- •Signing of the free and informed consent form-
排除标准
- •Use any associated orthopedic device to aid gait or balance control
- •Signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE)
- •Diagnosis of other neurological disorders (including those of central and peripheral nature)
- •Previous treatment with tDCS
- •Medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)
- •The use of pacemakers or other implanted devices.-
结局指标
主要结局
Change from COP - ML axis
时间窗: Baseline and Post-tDCS (immediately after tDCS)
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters.
Change from COP - AP axis
时间窗: Baseline and Post-tDCS (immediately after tDCS)
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters.
Change from COP - area
时间窗: Baseline and Post-tDCS (immediately after tDCS)
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²).
次要结局
未报告次要终点
研究者
Fuad Ahmad Hazime
Assistant Professor - Physical Therapy Department
Universidade Federal do Piauí