Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia
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
Cerebello-spinal direct current stimulation sham associated with locomotor training
干预措施: Sham cerebello-spinal direct current stimulation (Device)
Experimental I
Cerebellar transcranial current stimulation associated with locomotor training
干预措施: Cerebellar transcranial direct current stimulation (Device)
Experimental I
Cerebellar transcranial current stimulation associated with locomotor training
干预措施: Treadmill locomotor training (Other)
Sham comparator I
Cerebellar transcranial current stimulation sham associated with locomotor training
干预措施: Treadmill locomotor training (Other)
Sham comparator I
Cerebellar transcranial current stimulation sham associated with locomotor training
干预措施: Sham Cerebellar transcranial direct current stimulation (Device)
Experimental II
Cerebello-spinal direct current stimulation associated with locomotor training
干预措施: Treadmill locomotor training (Other)
Experimental II
Cerebello-spinal direct current stimulation associated with locomotor training
干预措施: Cerebello-spinal direct current stimulation (Device)
Sham comparator II
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
Kátia Monte-Silva
Clinical Professor
Universidade Federal de Pernambuco
