Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Spasticity: Neurophysiological measurement
研究概览
简要总结
Post-stroke spasticity in the lower extremity affects balance and gait, leading to decreased mobility and functional independence. Therefore, effective intervention for reducing spasticity is crucial in stroke rehabilitation. Recently, neurodynamics, though originally designed for pain management in orthopedic patients, has also been applied for treating spasticity in patients with neurological disorders. However, previous studies focused mainly on treating the upper extremity spasticity, but not on lower extremity spasticity, and not on possible neurophysiological changes. The present study aims to investigate the immediate effects of neurodynamics in reducing lower limb spasticity and neurophysiological changes in people with chronic stroke.
详细描述
Sample size calculation: There was no reference for the effect size of neurodymanics on reducing lower extremity spasticity, and the effect size of neurodynamics treatment for improving knee range of motion was between 0.89 to 2.55. We set the effect size of 0.6 (moderate effect size) with an alpha level of 5%, power at 80%, and a paired t-test model to calculate the sample size.
Statistical analysis
Paired t-test will be used for within condition (experimental or control condition) comparisons. The change values between pre and post in each condition will be calculated and compared by paired t-test for between condition comparisons. The significance is set at p< 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of first-ever stroke with unilateral lesion for more than 6 months
- •demonstrating calf muscle spasticity as indicated by modified Ashworth scale equal to or greater than 1
- •with passive ROM of ankle dorsiflexion at least to neutral position (defined as 0°)
- •ability to walk at least 10m independently without a walking device or ankle-foot orthosis (AFO)
- •sufficient cognition (mini-mental state examination, MMSE score of 24 or higher)
排除标准
- •contraindications to nerve conduction tests
- •other orthopedic and neurological disorders interfering participating in the study
结局指标
主要结局
Change in Spasticity: Neurophysiological measurement
时间窗: Before intervention and immediately after intervention
The H-reflex will be recorded by placing a disposable surface electrode on the muscle belly of the gastrocnemius after a stimulation of the tibial nerve just proximal to the electrode.
Change in Spasticity: Clinical measurement
时间窗: Before intervention and immediately after intervention
The modified Ashworth scale (MAS) will be used, which is a 6-point scale commonly used to assess muscle spasticity in clinical settings.
次要结局
- Change in Gait Performance(Before intervention and immediately after intervention)
- Change in Lower Extremity Motor Control(Before intervention and immediately after intervention)