跳至主要内容
临床试验/NCT02250690
NCT02250690Unknown不适用

Transcranial Direct Current Stimulation (tDCS) Associated With Gait Training in Improving Motor Function in Parkinson's Disease

Universidade Federal de Pernambuco0 个研究点目标入组 24 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
主要终点
Change on Bradykinesia

研究概览

简要总结

The aims of the present study was to analyze the effect of consecutive sessions of Transcranial direct current stimulation associated to kinesiotherapy about gait performance of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min) and stride length (m). The secondary outcome is motor cortex excitability which is analyzed by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor evoked potential amplitude (MEP) and rest motor threshold (rMT).

详细描述

This study consist by interventions involving screening followed by evaluation, where volunteers were subjected to the many tests: history, session III of the Unified Scale Modified Parkinson's Disease - Unified Parkinson 's Disease Rating Scale, Ten meters walk test - Walk Test 10 meters and shoot gait, (using Studio Version 8 software). On the same day, the subjects underwent assessment of brain excitability to determine motor threshold and amplitude of the motor evoked potential (MEP). The randomization of the volunteers was conducted by an external search through opaque envelopes ordered according to a random distribution. The subjects were divided into two groups : control group , this group submitted to Transcranial Stimulation sessions a sham Continuous Current (sham tDCS) and gait training , and Experimental group, subjected to the stimulation by Transcranial Direct Current sessions (active tDCS ) and gait training.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Main eligibility criteria were idiopathic Parkinson's disease
  • Hoehn and Yahr stage I to III
  • Showing mild to severe gait disturbances
  • Stable medication usage
  • Age 40 to 80 years
  • And absence of cognitive impairment and disorders interfering with participation in cueing therapy.

排除标准

  • Presence of chronic disabling pathologies of lower limb
  • Presence of pacemaker or severe cardiovascular conditions
  • A history of tumor, prior neurosurgical brain
  • Intervention, or severe cardiovascular conditions, including the presence of a pacemaker
  • A diagnosis of epilepsy or major psychiatric disorders.
  • Participants with other neurological, muscular, or psychiatric disorders (e.g. peripheral neuropathies, uncorrected visual problems, hearing problems, vestibular dysfunction, stroke, seizure, migraine, or frequent severe headaches) were excluded.
  • Participants with surgical implants, significant postural tremor, dyskinesia, severe freezing or dementia were also excluded.

结局指标

主要结局

Change on Bradykinesia

时间窗: This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session

This outcome will be measure in three different moments of evaluation and at all interventions (sessions) days - before and after intervention. Beyond these evaluations, the voluntairs will be evaluate at: T1- before ten sessions; T2- Immediately after ten sessions and T3- after a period of 1 month without intervention.

次要结局

  • Change on Cortical excitability(The evaluation occur in 3 different moments: before and after each session, after a period of 1 month without intervention. This outcome will be measure at all intervention and evaluation days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriana Carla Costa Ribeiro Clementino

Transcranial direct current stimulation (tDCS) associated with gait training in improving motor function in Parkinson's disease.

Universidade Federal de Pernambuco

相似试验

Neuromodulation on Motor Function in Parkinson's... | 临床试验