A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Functional Ambulation Categories
研究概览
简要总结
Phase I: Exploring what stroke survivors exactly learn when recovering the ability to stand and walk.
详细描述
GENERAL:
Pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy early after stroke. For example, training has led to substantial recovery if initiated 5 or 14, but not 30 days post-stroke in a rodent model (Biernaski 2004). It is suggested that this early period is characterized by heightened levels of plasticity and that training can exploit this leading to improved outcome. The typically observed non-linear recovery pattern in stroke survivors (Kwakkel 2004) might suggest that similar mechanisms are induced in the human brain, however clinical research on this is disappointingly sparse.
In two closely inter-related phases, we aim to examine the biomechanical changes related to walking recovery in general (Phase I) and the specific effects of robot-assisted training (Phase II). By that, we aim to detect a time window in stroke survivors which resembles the same characteristics as observed in animal models. To initiate gait training at an early stage, when patients usually present severe weakness and balance deficits, a mobile exoskeleton is used which is developed to provide intensive walking practice.
OBJECTIVES:
(I.a) Is there a distinct time window of behavioral restitution (i.e., returning towards pre-stroke movement patterns) underlying early walking recovery?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
- •Age: 18 - 90 years
- •Baseline assessments within the first 14 days after stroke onset
- •Weakness of the lower limb (NIHSS item >0 at 72 hours post-stroke)
- •Pre-morbid independence in activities of daily living (mRS </=2) and gait (FAC >3)
- •Able to communicate and comprehend
- •Sufficient motivation to participate
- •Provided a written informed consent
排除标准
- •No other neurological condition affecting motor functions of the lower limbs
- •Pre-existing musculoskeletal impairment severely affecting the gait pattern
结局指标
主要结局
Functional Ambulation Categories
时间窗: 12 weeks post-stroke]
This scale indicates the ability to walk independently and serves as the primary outcome measure.
次要结局
- Motricity Index - subscale lower limb(Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke)
- EMG analyses of standing balance & gait(3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke)
- Spatio-temporal analyses of gait(3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke.)
- Fugl Meyer Motor Assessment - subscale lower limb(Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke)
- Functional Ambulation Categories(Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke)
- Kinetic analyses of standing balance & gait(3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke)
- Trunk Control Test - item sitting balance(Baseline (0-1 week post-stroke))
- Berg Balance Scale - item standing unsupported(Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke)
研究者
Jonas Schröder
Principle investigator, PhD researcher
Universiteit Antwerpen