Impact of Transcranial Direct Current Stimulation (tDCS) on Locomotion and Bipedal Equilibrium in Hemiplegic Patients: a Crossover Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Quantify of variability of the center-of-mass movement
研究概览
简要总结
The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients.
详细描述
This is a pilot prospective randomised crossover double blind study. 40 patients will be enrolled in two sites, with 20 patients each site.
The duration of this study is planned to be 25 months: 24 months will be for enrollment and 1 month for the follow-up.
The follow-up of patient comprises 3 visits, will be extended to 28 days for each patient:
• V1: inclusion visit:
After obtained an informed consent signed, the following analysis will be realized: a clinical assessment, quantify analysis of walking using 3D motion analysis system, assessment of equilibrium using force plate and functional abilities.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral stroke
- •More than 6 months after stroke
- •Ability to walk during 10 minutes without stopping
- •Informed consent signed
- •Exclusion Criteria :
- •Patient with pacemaker
- •Claustrophobia (unable to perform a magnetic resonance imaging analysis)
- •Patient with severe aphasia or severe cognitive disorder interfering the follow-up of the trial
- •Neuro-orthopedic surgery history in the last 6 months on the studied paretic lower limb
- •Epilepsy history in the last year
- •Lack of medical insurance
- •Adult patient under the care of a guardian
- •Patient with progressive concomitant disease
- •Patient with deep brain stimulation treatment (implantation of medical device)
- •Patient with implantation of Intracranial metallic clip
- •Patient with implantation of Intracranial stent
- •Patient with implantation of ventriculoperitoneal derivation
- •Patient with implantation of intracerebral or ocular prosthetic materials
- •Patient with ferro-magnetic foreign object
- •Patient with cochlear implant
- •Patient with implantable cardioverter-defibrillator
排除标准
- 未提供
研究组 & 干预措施
sham and then anodal
visit 2 sham stimulation (120 seconds) and visit 3 anodal stimulation (30 minutes)
干预措施: anodal tDCS and sham tDCS stimulations (Device)
anodal and then sham
visit 2 anodal stimulation (30 minutes) and visit 3 sham stimulation (120 seconds)
干预措施: anodal tDCS and sham tDCS stimulations (Device)
结局指标
主要结局
Quantify of variability of the center-of-mass movement
时间窗: 30 minutes
Variability of the center-of-mass will be quantified during walking analysis and equilibrium assessment, for experimental and placebo visits (before, during and after stimulation) (V2 and V3) as well as in inclusion visit (V1).
次要结局
- Symmetry index calculating(30 Minutes)
- Continuous relative phase(30 Minutes)
- Functional data(30 minutes)