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临床试验/NCT03703830
NCT03703830Unknown不适用

Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Change in Functional mobility

研究概览

简要总结

Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Cerebellar ataxia
  • •Ages: 18 to 65 years;
  • •Gender: Both;
  • •Score ≥ 3 and < 8 in subscore of gait in the Scale for the Assessment and Rating of Ataxia

排除标准

  • •Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
  • •Pacemaker;
  • •History of seizures;
  • •Metallic implants in the head or neck;
  • •Medication change during the period of study

研究组 & 干预措施

Sham comparator II

Sham Comparator

Cerebello-spinal direct current stimulation sham associated with locomotor training

干预措施: Sham cerebello-spinal direct current stimulation (Device)

Experimental I

Experimental

Cerebellar transcranial current stimulation associated with locomotor training

干预措施: Cerebellar transcranial direct current stimulation (Device)

Experimental I

Experimental

Cerebellar transcranial current stimulation associated with locomotor training

干预措施: Treadmill locomotor training (Other)

Sham comparator I

Sham Comparator

Cerebellar transcranial current stimulation sham associated with locomotor training

干预措施: Treadmill locomotor training (Other)

Sham comparator I

Sham Comparator

Cerebellar transcranial current stimulation sham associated with locomotor training

干预措施: Sham Cerebellar transcranial direct current stimulation (Device)

Experimental II

Experimental

Cerebello-spinal direct current stimulation associated with locomotor training

干预措施: Treadmill locomotor training (Other)

Experimental II

Experimental

Cerebello-spinal direct current stimulation associated with locomotor training

干预措施: Cerebello-spinal direct current stimulation (Device)

Sham comparator II

Sham Comparator

Cerebello-spinal direct current stimulation sham associated with locomotor training

干预措施: Treadmill locomotor training (Other)

结局指标

主要结局

Change in Functional mobility

时间窗: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day

The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility.

次要结局

  • Change in Balance(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.)
  • Change in Ataxia severity(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.)
  • Change in Fall risk(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.)
  • Change in Patient global impression(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day)
  • Adverse effects of ctDCS(25 minutes after the beginning of stimulation)

研究者

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

Kátia Monte-Silva

Clinical Professor

Universidade Federal de Pernambuco

研究点 (1)

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