Effect of Dynamic Pressotherapy on Vascular, Functional and Quality of Life Outcomes in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Augmentation Index
研究概览
简要总结
This study intends to recruit stroke patients to either wearing a lower-limb compression (GMove) suit, daily, for 12 weeks, or to a normal therapy control group. Vascular, functional and quality of life outcomes will be collected before and after randomisation.
详细描述
Background/Rationale Stroke is a leading cause of adult disability in the UK, with over 1.2 million people living with the debilitating effects. It is estimated that approximately three quarters of individuals with stroke have fallen in the six months following discharge from hospital, and more recent research suggests that falls rates remained as high as 50% amongst those living in the community following stroke. With falls costing the National Health Service approximately £1.7 billion per year, neurorehabilitation is vital in order to improve balance and prevent falls in the stroke population. Evidence suggests that a key component of improving balance and mobility is through task-specific training that incorporates actual walking practice and lower limb muscle strengthening.
Dynamic pressotherapy is defined as a movement of compression/decompression, associated with a physical effort at variable intensity, in order to stimulate venous return. The GMOVE Suit (CE Marked; GMOVE-SUIT - GMOVE SUIT; Appendix B) is a lower limb active pressotherapy device that may increase muscle activity and muscle tone, and support mobility renewal by stimulating the activation of lower-limb muscle pumping and muscle restraint during physical activity (via periods of compression/decompression of the device). In clinical populations, case studies with people with Ehlers-Danlos Syndrome, Parkinson's Disease, Spinal Cord Injury, Stroke and Multiple Sclerosis, have demonstrated improvements in proprioception, functional outcomes, including the 'Get Up and Go' test, knee stability and control, and walking with greater hip and knee extension following regular usage of the GMOVE Suit.
Due to the portability of the device, there is substantial potential to use the GMOVE Suit in a home-based rehabilitation environment, whereby participants would have the potential to engage in daily physical activity whilst wearing the device. As the GMOVE Suit may encourage an increase in physical activity, there could be substantial benefit in stroke patients engaging in a structured (as determined by a neuro-physiotherapist), home-based rehabilitation programme which may improve vascular health (e.g., blood pressure), functional outcomes (walking speed, walking endurance), balance and general quality of life.
Purpose The purpose of this research is to undertake a pilot randomised controlled study which will examine the effect of a home-based dynamic pressotherapy rehabilitation intervention, using the GMOVE Suit, on functional, vascular and quality of life parameters in individuals with chronic stroke.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Patients with clinical diagnosis of stroke (within 3 months and 7 years of diagnosis)
- •Community patients that are medically stable
- •Individuals who are able to stand and step (at least 10m) with (or without) an aid or assistance
- •Cognitively aware of task demands
排除标准
- •Unresolved deep vein thrombosis
- •Unstable cardiovascular conditions
- •Open wounds
- •Active drug resistant infection
- •Recent fractures of involved limb
- •Peripheral arterial disease
- •Severe osteoporosis
- •Non weight bearing
结局指标
主要结局
Augmentation Index
时间窗: Baseline, up to 12 weeks after baseline.
Pulse wave analysis (PWA) will investigate augmentation index as a percentage following 15 minutes supine rest.
Central blood pressure
时间窗: Baseline, up to 12 weeks after baseline.
Pulse wave analysis (PWA) will investigate central blood pressure in mmHg following 15 minutes supine rest.
Peripheral blood pressure
时间窗: Baseline, up to 12 weeks after baseline.
Pulse wave analysis (PWA) will investigate peripheral blood pressure in mmHg following 15 minutes supine rest.
Pulse Wave Velocity
时间窗: Baseline, up to 12 weeks after baseline.
Pulse wave velocity (PWV) will be recorded between the carotid (right and left) and femoral artery, brachial artery and femoral artery, and femoral artery and the anterior tibial artery. All PWV measures will be recorded in metres per second
次要结局
- 6 minute walk test(Baseline, up to 12 weeks after baseline.)
- 10 m walk test(Baseline, up to 12 weeks after baseline.)
- Berg Balance(Baseline, up to 12 weeks after baseline.)
- Balance Confidence Scale(Baseline, up to 12 weeks after baseline.)
- Functional Ambulation Classification(Baseline. Each assessment will take 2 minutes)
- Height(Baseline, up to 12 weeks after baseline.)
- Body Mass Index (BMI)(Baseline, up to 12 weeks after baseline.)
- Waist-to-Hip ratio(Baseline, up to 12 weeks after baseline.)
- Sit to Stand(Baseline, up to 12 weeks after baseline.)
- Time-Up-And-Go(Baseline, up to 12 weeks after baseline.)
- Fugl-meyer assessment(Baseline, up to 12 weeks after baseline.)
- Weight(Baseline, up to 12 weeks after baseline.)