Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients - a Multicentric Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 14
- 主要终点
- Gait speed by 10 meters Walk Test (in meter /second) results
研究概览
简要总结
The aim of the vibration intervention proposed in the current study is to allow a better neuromotor recovery in subacute stroke patients when compared with standard rehabilitation alone. These last years, it has been proven that the solicitation of a muscle using vibrations may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition to a standard rehabilitation program of local vibrations sessions of the dorsiflexor muscles of the paretic limb of stroke patients may allow a better recovery of walking speed (primary outcome). One group using vibrations (i.e. experimental group) and one group with sham vibration (i.e. control group) will take part to this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)
- •Presenting with a stroke, ischemic or hemorrhagic
- •Lower-limb deficiency with an initial motor testing < 4 according to the MRC scale
- •No neurological history with functional impact other than stroke
- •Having received informed information about the study and having signed the written consent
- •Affiliated or entitled to a social security scheme.
- •Patients under guardianship may be included; they may give their consent with the assistance of their guardian.
- •If the participant is unable to write, their consent may be given and documented by other appropriate means in the presence of at least one impartial witness. In this case, the witness will sign and date the informed consent document.
排除标准
- •Multiple stroke
- •Other neurological, cognitive or psychiatric conditions
- •Orthopedic ankle history compromising measurements
- •Botulinum toxin injected in the lower limb prior the study protocol
- •Patient with phlebitis or risk of thrombosis in the lower limb
- •Patient under tutorship
结局指标
主要结局
Gait speed by 10 meters Walk Test (in meter /second) results
时间窗: Month 2
Analysis Gait speed by 10 meters Walk Test (in meter /second) results
次要结局
- Walking performance by 2 Minute Walk Test (2MWT) (in meter) results(Month 0, 1, 2, 3, 4)
- Walking performance by 10 meters Walk Test (in meter /second) results(Month 0, 1, 2, 3, 4)
- Walking performance by Quantified Gait Analysis results(Month 2, 4)
- Lower limb spasticity level(Month 4)
- Autonomy in walking activities(Month 4)
- Lower limb strength(Month 4)
- Motor function of the paretic lower limb(Month 4)
- Neuromuscular fatigue (1)(Month 4)
- Neuromuscular fatigue (2)(Month 4)
- Neuromuscular fatigue (4)(Month 4)
- Neuromuscular fatigue (3)(Month 4)