The Effects of Exercise and Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Paretic knee concentric muscle strength
研究概览
简要总结
The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke.
Subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be 30Hz. The total duration of exposure to vibration for the experimental group will be 10 minutes. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. The training will be conducted by a qualified personnel with physiotherapy background.
The outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. Each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.
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
- 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
- 否
入选标准
- •a diagnosis of stroke more than 6 months
- •medically stable
- •able to understand verbal commands
- •Abbreviated mental test score 6 or above
- •able to stand with or without aids for at least 1.5 minutes
排除标准
- •neurological conditions other than stroke
- •significant musculoskeletal conditions (e.g. amputations)
- •metal implants in the lower extremity
- •previous fracture of the lower extremity
- •are currently taking bone resorption inhibitors or were taking the same before stroke.
- •significant peripheral vascular disease
- •vestibular disorders
- •pregnancy
- •Other serious illnesses that preclude the person from participating in the study
研究组 & 干预措施
Control
The control group will perform the same exercises on the vibration platform, as in the experimental group. However, the vibration device will be turned off during the exercises.
干预措施: Exercise on the vibration platform with the device turned off (Device)
Whole body vibration
Subjects in the experimental group will undergo whole body vibration (1 session per day, 3 sessions per week) for 8 weeks. The vibration loading will be carried out using the Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea). The vibration protocol used in this study will be 30Hz. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2)deep squatting , (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The total duration of exposure of whole body vibration per session will be about 10 minutes.
干预措施: Whole body vibration therapy (Device)
结局指标
主要结局
Paretic knee concentric muscle strength
时间窗: Follow-up (week 12)
Paretic knee concentric muscle strength
时间窗: pre-test (week 0)
Paretic knee concentric muscle strength
时间窗: Post-test (week 8)
次要结局
- Limit of stability test(Follow-up (week 12))
- Non-paretic concentric knee muscle strength(Pre-test (week 0))
- Non-paretic knee concentric muscle strength(Follow-up (week 12))
- Paretic knee eccentric muscle strength(WFollow-up (week 12))
- Berg balance test(Follow-up (week 12))
- Activities-specific Balance Confidence Scale(Follow-up (week 12))
- Six Minute Walk Test(Follow-up (week 12))
- Non-paretic knee eccentric muscle strength(Follow-up (week 12))
- Paretic knee isometric muscle strength(Follow-up (week 12))
- Non-paretic knee isometric muscle strength(Follow-up (week 12))
- Self-selected gait velocity(Follow-up (week 12))
- Bone formation marker level(Follow-up (week 12))
- Bone resorption marker level(Follow-up (week 12))
- fall rate(6 months after termination of treatment)
- Knee spasticity(Follow-up (week 12))
- Ankle spasticity(Follow-up (week 12))
- Level of satisfaction(Post-test (week 8))
- Non-paretic knee isometric muscle strength(Pre-test (week 0))
- Non-paretic knee eccentric muscle strength(Pre-test (week 0))
- Non-paretic knee eccentric muscle strength(Post-test (week 8))
- Paretic knee isometric muscle strength(Pre-test (week 0))
- Non-paretic knee concentric muscle strength(Post-test (week 8))
- Paretic knee eccentric muscle strength(pre-test (week 0))
- Paretic knee eccentric muscle strength(Post-test (week 8))
- Paretic knee isometric muscle strength(Post-test (week 8))
- Non-paretic knee isometric muscle strength(Post-test (week 8))
- Limit of stability test(Pre-test (week 0))
- Limit of stability test(Post-test (week 8))
- Berg balance test(Pre-test (week 0))
- Berg balance test(Post-test (week 12))
- Activities-specific Balance Confidence Scale(Pre-test (week 0))
- Activities-specific Balance Confidence Scale(Post-test (week 8))
- Six Minute Walk Test(Pre-test (week 0))
- Six Minute Walk Test(Post-test (week 8))
- Self-selected gait velocity(Pre-test (week 0))
- Self-selected gait velocity(post-test (week 8))
- Bone formation marker level(pre-test (week 0))
- Bone formation marker level(Post-test (week 8))
- Bone resorption marker level(pre-test (week 0))
- Bone resorption marker level(post-test (week 8))
- Knee spasticity(Pre-test (week 0))
- Knee spasticity(Post-test (week 8))
- Ankle spasticity(Pre-test (week 0))
- Ankle spasticity(Post-test (week 8))
研究者
Marco Yiu-Chung Pang
Associate Professor
The Hong Kong Polytechnic University