NCT01822704Unknown不适用
Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Isometric knee muscle strength
研究概览
简要总结
This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals with chronic stroke. It is hypothesized that the whole body vibration program will induce significantly more gain in physical functioning, societal participation, and quality of life in chronic stroke patients, compared with the control group.
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
- •diagnosis of a hemispheric stroke
- •chronic stroke (onset of 6 months or more)
- •aged 18 years or older
- •medically stable
- •able to stand for at least 1 minute with hand support
- •Abbreviated Mental Test score at 6 or more
- •Chedoke McMaster Stroke Assessment leg or foot score less than 7 points
排除标准
- •recurrent stroke
- •brainstem or cerebellar stroke
- •other neurological conditions
- •significant musculoskeletal conditions (e.g. amputations)
- •vestibular disorders
- •peripheral vascular disease
- •other serious illnesses
- •other contraindications to exercise.
结局指标
主要结局
Isometric knee muscle strength
时间窗: week 10
次要结局
- Average oxygen consumption rate during the Six Minute Walk Test(week 10)
- Eccentric knee muscle strength at a velocity of 60 degrees per second(week 10)
- Time taken to complete the Five-times-sit-to-stand test(week 10)
- Balance score as measured by the Mini-Balance Evaluation Systems Test(week 10)
- Quality of life score as measured by the 12-item Short Form Health Survey(week 10)
- Distance walked in the Six Minute Walk Test(week 10)
- Time taken to complete the Timed Up and Go Test(week 10)
- Ankle spasticity score as measured by the Modified Ashworth Scale(week 10)
- Concentric knee muscle strength at a velocity of 60 degrees per second(week 10)
- Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors(week 10)
- Distance reached in the Functional Reach test(week 10)
- Walking ability as measured by the Functional Ambulation Category(week 10)
- Balance confidence scores as measured by the Activities-specific Balance Confidence Scale(week 10)
- Level of activity participation as measured by the Frenchay Activities Index(Week 10)
研究者
Marco Yiu-Chung Pang
Associate Professor
The Hong Kong Polytechnic University
研究点 (1)
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