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
- 19
- 试验地点
- 4
- 主要终点
- Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE)
研究概览
简要总结
Phase II: Investigating the effects of additional robot-assisted gait training either initiated early (2 weeks post-stroke) or delayed (8 weeks post-stroke) after stroke onset.
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:
(II.a) Are stroke survivors who train with the assistance of a robot at an early stage more likely to achieve independent walking?
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)
盲法说明
A blinded assessor will be allocated to a certain participant when she/he was succesfully enrolled. This means that the same assessor will perform the clinical assessments (i.e., FAC, 10-m Walk Test, FM, MI) at the different measurement occasions for this participant to avoid inter-assessor variability effects on longitudinal recovery trajectories.
入排标准
- 年龄范围
- 18 Years 至 80 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
- •Unable to walk independently at baseline (FAC <3)
- •Moderate to severe weakness of the lower limb at baseline (MI </=75)
- •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
- •Body weight > 100 kg
- •Severe spasticity or contractures that prevent safe use of the exoskeleton
- •Medically unstable to participate in additional therapy sessions
结局指标
主要结局
Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE)
时间窗: Longitudinal change is determined between the following time points: 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
This scale measures the level of of volitional, selective control of muscles of the paretic lower limb. Scoring: This scale is scored from 0 (no reflex activity) to 34 (volitional movement out of synergies).
次要结局
- 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)
- 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.)
- Motricity Index - subscale lower extremity (MI-LE)(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 (FAC)(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)
- 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)
- 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)
研究者
Jonas Schröder
Principle investigator, PhD researcher
Universiteit Antwerpen