NCT07073989招募中不适用
Investigating the Impact of Afferent Stimulation on Proprioceptive Function in Post-Stroke Rehabilitation
Julio S. Lora Millán1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Motor illusion
研究概览
简要总结
The objective of this study is to assess the functionality of a sensory stimulation device that uses mechanical vibrations and low-intensity electrical currents to deliver proprioceptive feedback to stroke patients regarding their movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For healthy subjects:
- •No neurological or orthopedic conditions affecting upper limb movement.
- •No surgical interventions on the upper limbs within the past 6 months.
- •General physical condition adequate to perform the session.
- •Cognitive abilities sufficient to understand and carry out the experimental procedure.
- •For stroke survivors:
- •Ischemic or hemorrhagic stroke resulting in motor impairments in the upper limb.
- •Chronic stroke condition.
- •Subjects with sufficient cognitive abilities to follow instructions and actively participate in the therapy.
- •Mini-Mental State Examination (MMSE) score >
- •Subjects presenting hemiparesis and mild-to-moderate impairment in the upper limb (score on the Fugl-Meyer Motor Assessment for the upper limb, sections A-D, between 35 and 53 points). The maximum score on the FM scale is 66, with the following severity classifications:
- •0-15: severe impairment
- •16-34: moderate-to-severe impairment
- •35-53: mild-to-moderate impairment
- •54-66: mild impairment
- •Subjects presenting upper limb hypertonia with a score below 3 on the Modified Ashworth Scale.
- •Subjects who have signed the informed consent document to voluntarily participate in the experiments.
排除标准
- •Acute musculoskeletal disorders.
- •Peripheral vascular diseases.
- •Acute cardiopulmonary conditions.
- •Acute neurological disorders.
- •Restricted mobility of upper limb joints due to any cause.
- •Pain as a cause of impaired upper limb mobility.
研究组 & 干预措施
Healthy subjects
Experimental
Intervention applied to healthy subjects
干预措施: Afferent stimulation (Device)
Stroke patients
Experimental
Stimulation applied to stroke patients
干预措施: Afferent stimulation (Device)
结局指标
主要结局
Motor illusion
时间窗: Periprocedural
Motor illusion is evaluated by instructing the patient to replicate the movement they experienced in the contralateral limb. Inertial sensors will be placed in such limb to acquire the movement performed by the subject.
次要结局
未报告次要终点
研究者
Julio S. Lora Millán
Principal Investigator
Universidad Rey Juan Carlos
研究点 (1)
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