The Effects of 4 Weeks of Chiropractic Care Plus Physiotherapy Compared to Physiotherapy Alone on Functional Outcomes in Chronic Stroke Patients: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
The Investigator recently conducted a study in patients who had suffered from a stroke where it investigated whether similar findings are observed following a single session of chiropractic care.36 The key findings from this study was that in a group of chronic stroke patients, with lower limb muscle weakness, plantar flexion muscle strength increased on average by 64.6% following a chiropractic care session and the change in muscle strength appears to be modulated by cortical factors as opposed to modulation at the spinal level.
Based on the promising results of this initial study now planning to perform a pragmatic pilot clinical trial that will investigate the effects of 4 weeks of chiropractic care on clinical measures associated with stroke rehabilitation and function
详细描述
Stroke is one of the leading causes of death and disability in the world. It is estimated that 17 million people per year suffer from a significant stroke worldwide, with 5 million of those people experiencing long term physical disability following the stroke. The global burden of stroke continues to rise even though the rate of stroke-related mortality has decreased over recent years. Stroke often results in prolonged physical, emotional, social and financial consequences for stroke survivors, family, friends, and caregivers. One of the most commonly occurring deficits associated with strokes is hemiparesis, which affects upper limb function, or an individual's ability to stand, balance or walk. The long term impaired nervous system function that accompanies many strokes means millions of stroke survivors around the world are reliant on care-givers to assist them with rudimentary activities of daily living such as bathing, dressing, and toileting. The burden of care is immense and has a significant impact on modern society.
This burden is even higher in developing countries. Disability-adjusted life years (DALYs), which is a measure of both years of life lost and years lived with a disability, is seven times higher in developing countries compared to high-income countries. While part of this difference is possibly due to differences in age, incidence, and mortality in developing countries; the mortality of stroke has dropped by 20% while the age-standardized incidence of stroke increased by 12% between 1990 and 2010 in low and middle-income countries. This means more people have strokes, more survive, and as a result, the burden of stroke is even greater in developing countries.
Numerous rehabilitative approaches have been shown to promote motor recovery after a stroke, but advanced strategies are constantly being developed and tested in an attempt to improve long term outcomes for stroke survivors. One possible intervention that may improve post-stroke motor recovery, but has to date not been adequately tested, is chiropractic care.
Over the past two decades, numerous research studies have shown that chiropractic care can significantly influence central neural function. Studies have shown changes in somatosensory processing, sensorimotor integration and motor control following as little as a single session of chiropractic care. Sensorimotor integration is the ability of the central nervous system (CNS) to integrate sensory information from different body parts and formulate appropriate motor outputs to muscles. Effective sensorimotor integration is essential when learning new motor skills, or recovering from an injury. Another essential component for accurate movement, learning new motor skills, and/or recovering from an injury is the accuracy of internal representations of our body map, or body schema. It is essential for our brain to be accurately aware of the location of our limbs and core body in 3D space. The spine is linked biomechanically and neurologically to the limbs and yet, it know very little about how altered sensory feedback from the spine affects limb sensorimotor integration and motor performance. However, there is emerging evidence that altered spinal sensory input can alter central neural processing, possibly by impacting the brains inner body schema. There is also emerging evidence that improving spinal function with chiropractic care can rapidly alter central neural function in a variety of ways, and that these changes outlast the altered changes of input, i.e. that they are neural plastic changes.
It has been hypothesised that the central neural plastic changes that are observed following chiropractic care may be due to improvements in spinal function associated with the correction of vertebral subluxations. Vertebral subluxations have been defined as a diminished state of being, comprising of a state of reduced coherence, altered biomechanical function, altered neurological function and altered adaptability.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the outcome assessors ( Physiotherapists), and data analysts will remain blinded to group allocation throughout the study period.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients must have suffered from a stroke at least 12 weeks prior to their involvement in the trial
- •have ongoing neurological deficits
- •upper and/or lower limb weakness
- •with a Fugl-Meyer Assessment (FMA) motor score of less than 80 at the time of enrolment.
排除标准
- •have absolute contraindications to chiropractic adjustments
- •have experienced previous significant adverse reactions to chiropractic care or any type of manual therapy
- •are unable to provide informed consent to participate in the trial due to cognitive impairment.
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: baseline,4th week, 8th week
Changes from the Baseline, The Fugl-Meyer Assessment (FMA) (combined upper and lower limb )is a stroke-specific, performance-based impairment index. It is designed to assess motor function, balance, sensation and joint function in patients with post-stroke hemiplegia. It is applied clinically and in research to determine stroke severity, describe motor recovery, and to plan and assess treatment. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. Only the Motor Part: Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance).Classifications for impairment severity have been proposed based on FMA Total motor scores (out of 100 points) \[\< 50 = Severe, 50-84 = Marked, 85-94 = Moderate and 95-99 = Slight \]
次要结局
- Daily Movement(1 Week)
- Blood Marker (Brain-derived neurotrophic factor, BDNF)(baseline,4th week, 8th week)
- Stroke Specific Quality of Life Scale(baseline,4th week, 8th week)
- Modified Rankin Scale (mRS)(baseline,4th week, 8th week)
- Heart Rate Variability(HRV)(baseline,4th week, 8th week)
- Blood Marker (Insulin-like growth factor 2, IGF2)(baseline,4th week, 8th week)
- Blood marker (Glial cell-derived neurotrophic factor, GDNF)(baseline,4th week, 8th week)
- Timed up and Go Test (TUG)(baseline,4th week, 8th week)
