Comparison Between Mechanisms Underlying Effects of Repetitive Peripheral Nerve Stimulation on Upper Limb Motor Performance in the Subacute and Chronic Phases After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Jebsen-Taylor Test
研究概览
简要总结
Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
An amendment for performance of a minimization procedure in order to enhance the probability of comparable characteristics between the groups was approved. The researcher responsible for minimization is not involved in data collection or analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging, between 7 days - 3 months before enrollment (subacute phase), and at least 6 months (chronic phase).
- •Ability to perform at least 4 of 7 tasks performed in daily life that is part of the Jebsen-Taylor Test
排除标准
- •Anesthesia of the paretic hand.
- •Lesions affecting the motor cortex (hand area).
- •Lesions affecting cerebellum, or cerebellar pathways in the brainstem.
- •Severe spasticity at the paretic elbow, fist or fingers, defined with a score larger than 3 on the Modified Ashworth Scale.
- •Neurological diseases such as Parkinson disease or chronic uncontrolled chronic disease such as cancer or cardiac insufficiency.
- •Elbow pain or join deformity in the paretic limb.
- •Pregnancy.
- •Uncontrolled psychiatric disease.
- •Aphasia or severe cognitive deficit.
- •Inability to provide consent.
- •Inability to attend the experimental sessions.
结局指标
主要结局
Change in Jebsen-Taylor Test
时间窗: Immediately after one session of intervention
Test of upper limb dexterity
次要结局
- Change in lateral pinch strength(Immediately after one session of intervention)
- Change in gamma-aminobutyric acid levels in primary motor cortex(Immediately after one session of intervention)
- Change in brain perfusion(Immediately after one session of intervention)
- Change in grasp strength(Immediately after one session of intervention)