Effects of Treadmill Gait Training With Adding Load on Lower Limb of Individuals With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Ground reaction force, in Newtons
研究概览
简要总结
The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke.
详细描述
This is a randomized and blinded clinical trial, in which participants are being randomly divided into experimental group and control group, in order to verify the effects of adding load on gait symmetry after stroke. 40 individuals will participate, and the calculation of sample size was performed from the ratio variable symmetry of swing time, based on previous study. Whereas about 15% of individuals could give up to participate in the study during their course (dropout rate), we determined a number of 20 participants in each group.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First episode of stroke (ischemic or hemorrhagic) which determined unilateral hemiparesis
- •Time of lesion less one year
- •Able to walk independently by 10 feet on flat surface without the use of assistive devices
- •Gait speed less than 0.8 m / s
- •Ability to understand and obey simple commands
排除标准
- •Instability of cardiac conditions
- •Adverse clinical conditions affecting balance and / or gait
- •Pain and / or severe discomfort that impede the realization of the proposed activities
- •Decompensation in systemic blood pressure, with the systolic and diastolic values above 200 mmHg and 110 mmHg, respectively, before and / or after training
- •Submaximal heart rate above the allowed values during training
结局指标
主要结局
Ground reaction force, in Newtons
时间窗: Until one year after stroke
Vertical component of ground reaction force, measured using a force platform
Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)
时间窗: Until one year after stroke
Spatiotemporal gait variable, measured by a system of movement analysis
Angular displacements of hip, knee and ankle (in degrees)
时间窗: Until one year after stroke
Angular gait variables, measured by a system of movement analysis.
次要结局
- speed (meters/second)(Until one year after stroke)
- stride length (in meters)(Until one year after stroke)
- double support time (in seconds)(Until one year after stroke)
- step length (in meters)(Until one year after stroke)
研究者
Ana Raquel Rodrigues Lindquist, PhD
PhD
Universidade Federal do Rio Grande do Norte