Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Functional Ambulatory Category
研究概览
简要总结
The purpose of the first part of this study is to understand plastic brain mechanisms associated with successful gait-oriented stroke rehabilitation. Patients are randomized to receive intensive in-patient multiprofessional rehabilitation at different time points. One group will receive rehabilitation immediately after an acute care at the neurological clinic (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy. In addition to selected parameters measuring brain plasticity, detailed assessments of functional abilities including motor ability and quality of life will be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and recovery.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first supratentorial stroke or no significant disturbance from an earlier stroke (Modified Ranking Scale, MRS 0-2)
- •time since onset of stroke no more than 10 days
- •Functional Ambulatory Category (FAC) 0-3
- •voluntary movement in the leg of the affected side
- •Barthel Index (BI) 25-75 points- no unstable cardiovascular disease
- •Body Mass Index (BMI) <32
- •no severe malposition of joints
- •no severe cognitive or communicative disorders
- •no other health-related or social barriers to participate intensive rehabilitation
排除标准
- •ICH, or MRS >2
- •time since onset of stroke more than 10 days
- •no voluntary movement in the leg of the affected side
- •BI <25 or >75
- •severe malposition of joints
- •severe cognitive or communicative disorders
结局指标
主要结局
Functional Ambulatory Category
时间窗: 4 measures during six months
Barthel Index
时间窗: 4 measures during 6 months
次要结局
- 10 meters's walking speed(4 measures during 6 months)
- 6 minutes' walking distance(4 measures during 6 months)
- Berg Balance Scale(4 measures during 6 months)
- Functional Status Questionnaire(4 measures during 6 months)
- Geriatric Depression Scale -15(4 measures during 6 months)
- Beck Depression Intervention modified by Raitasalo(4 measures during 6 months)
- Modified Motor Assessment Scale(4 measures during 6 months)
- Postural sway by Good Balance(3-4 measures during 6 months)
- spatio-temporal gait analysis by GaitRite(3-4 measures during 6 months)
- WHOQOF-BREF(at end and at 6 months' follow-up)
- TMS responses (MT,MEPs,SP,SICI)(4 measures during 6 months)