Effect of Robot-assisted Gait Training in Patients With Parkinson's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 10 meter walk test (sec) : single task
研究概览
简要总结
Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by repeating a normal gait pattern with high intensity. This study is a randomized controlled trial to investigate the effect of robot-assisted gait training on walking ability and functional connectivity of brain in patients with Parkinson's disease using an exo-skeletal robot.
详细描述
Parkinson's disease is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.
Patients with Parkinson's disease are known to exhibit changes in functional connectivity of the brain from an early stage. In addition, a number of studies have reported that patients with Parkinson's disease with gait freezing have a change in resting brain activity and functional connectivity of the brain. However, no studies have examined the functional connectivity of the brain in patients with Parkinson's disease before and after rehabilitation.
Robot-assisted gait training is a method of rehabilitation that repeats normal gait patterns at high intensity. Recent meta-analysis has shown that robot-assisted gait training improved the recovery of independent gait after stroke compared with conventional rehabilitation therapy. On the other hand, robot-assisted gait training in Parkinson's disease has been reported to improve walking speed and walking endurance compared to conventional physical therapy, but is not superior to treadmill exercise of the same intensity. In addition, it has been reported that in patients with Parkinson's disease with balance impairment, robot-assisted gait training can improve balance disorder compared with physical therapy, and gait freezing has improved in some small-scale patients. However, studies on the effectiveness of robot-assisted gait training in Parkinson's disease are still lacking, and the mechanism of the effect has not been elucidated. In particular, the effect on gait automaticity, which is a characteristic of Parkinson 's disease, and functional connectivity of the brain has not been studied. Therefore, this study is aimed to investigate the effect of robot-assisted gait training on walking ability and functional connectivity of brain in patients with Parkinson's disease using an exo-skeletal robot.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed patients with idiopathic Parkinson's disease
- •Hoehn & Yahr stage 2.5 or 3 patients
- •Patients with a Mini-Mental Status Examination (MMSE) score of 24 or higher
排除标准
- •Patients with severe dyskinesia or on-off fluctuations due to medication
- •Patients who need to change drugs during the study period
- •Patients with sensory abnormalities of the lower limb
- •Patients with vestibular disease or paroxismal vertigo
- •Patients with other neurological or orthopedic disease involving legs, or severe cardiovascular diseases
结局指标
主要结局
10 meter walk test (sec) : single task
时间窗: at 4 weeks
次要结局
- 10 meter walk test (sec) : single task(baseline, at 8 weeks)
- 10 meter walk test (sec) : cognitive dual-task(baseline, at 4 weeks, at 8 weeks)
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part I(baseline, at 4 weeks, at 8 weeks)
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part IV(baseline, at 4 weeks, at 8 weeks)
- Berg balance scale(baseline, at 4 weeks, at 8 weeks)
- Korean version of Falls Efficacy Scale-International(baseline, at 4 weeks, at 8 weeks)
- 10 meter walk test (sec) : physical dual-task(baseline, at 4 weeks, at 8 weeks)
- New Freezing of Gait questionnaire (NFOG-Q) - Part II, III(baseline, at 4 weeks, at 8 weeks)
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part III(baseline, at 4 weeks, at 8 weeks)
- Timed-up & go test (sec)(baseline, at 4 weeks, at 8 weeks)
- New Freezing of Gait questionnaire (NFOG-Q) - Part I(baseline, at 4 weeks, at 8 weeks)
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part II(baseline, at 4 weeks, at 8 weeks)
- Functional connectivity in resting-state fMRI (Correlation coefficient)(baseline, at 4 weeks)
研究者
Han Gil Seo
Associate Professor
Seoul National University Hospital