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临床试验/NCT03015545
NCT03015545已完成不适用

The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Muscle stiffness of paretic medial gastrocnemius

研究概览

简要总结

Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-stroke. This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness, and blood perfusion in people with chronic stroke.

详细描述

Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in management of spastic hypertonia post-stroke. However, the potential effects of WBV on leg muscle stiffness in stroke rehabilitation remains unknown. Scientific evidence is warranted to fill the knowledge gap.

Purpose This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness and blood perfusion in people with chronic stroke.

Methods Individuals with chronic stroke will be recruited from community self-help groups and existing patient database. Relevant information (e.g. demographic information, medical history) will be obtained from medical records and subject interviews. Each subject will have to fulfill the following inclusion criteria: (1) diagnosis of chronic stroke, (2) community-dwelling, (3) able to follow simple verbal instructions. Exclusion criteria are: (1) other diagnoses of neurological conditions, (2) significant musculoskeletal conditions (e.g. amputations), (3) metal implants in the lower extremity or spine, (4) recent fracture in the lower extremity, (5) diagnosis of osteoporosis, (6) vestibular disorders, (7) peripheral vascular disease, and (11) other serious illnesses or contraindications to exercise.

This is a single-blinded randomized within-patient cross-over study. Each participant was evaluated for the soleus H-reflex, stiffness and blood perfusion of the medial gastrocnemius (MG) using ultrasound on both sides before and after either a 5-minute WBV intervention (30 Hertz, 1.5mm, knee flexed 60 degrees) or a no-WBV condition (5 minutes). The measurements were performed at baseline and every 1-min post-intervention up to 5 minutes. The outcomes generated included the soleus H/M ratio, shear modulus and vascular index (VI) of the MG muscle.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult with a diagnosis of a hemispheric stroke >6 months,
  • Medically stable,
  • Able to stand independently for at least 1 minute and
  • Mas score >1 measured at the ankle plantar flexors.

排除标准

  • Brainstem or cerebellar stroke,
  • Other neurological condition,
  • Serious musculoskeletal or cardiovascular disease,
  • Severe contracture of the ankle that the cannot be put in the neutral position.
  • Metal implants or recent fractures in the lower extremities or spine,
  • Fresh skin wound in lower extremities, especially popliteal fossa
  • Other severe illnesses or contraindication for exercise.

研究组 & 干预措施

Control

Active Comparator

This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval, but no vibration will be given.

干预措施: paretic leg-control (Device)

Control

Active Comparator

This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval, but no vibration will be given.

干预措施: non-paretic leg-control (Device)

High intensity whole body vibration

Active Comparator

This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval. The whole body vibration platform will be set with frequency at 30Hz and amplitude at 1.5mm.

干预措施: paretic leg-WBV (Device)

High intensity whole body vibration

Active Comparator

This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval. The whole body vibration platform will be set with frequency at 30Hz and amplitude at 1.5mm.

干预措施: non-paretic leg-WBV (Device)

结局指标

主要结局

Muscle stiffness of paretic medial gastrocnemius

时间窗: 5th minute after the intervention

Measured by Supersonic elastography with ankle in neutral position

H-reflex of paretic soleus muscle

时间窗: 5th minute after the intervention

To measure the efficacy of synaptic transmission

H-reflex of non-paretic soleus muscle

时间窗: 5th minute after the intervention

To measure the efficacy of synaptic transmission

Muscle stiffness of non-paretic medial gastrocnemius

时间窗: 5th minute after the intervention

Measured by Supersonic elastography with ankle in neutral position

次要结局

  • MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle(4th minute after the intervention)
  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle(5th minute after the intervention)
  • Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle(5th minute after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Yiu-Chung Pang

Professor

The Hong Kong Polytechnic University

研究点 (1)

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