Effects of Functional Massage Combined With Eccentric Exercise on Muscle Tone and Motor Function of the Lower Limb in Patients With Chronic Stroke: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Muscle tone will be assessed by modified Ashworth scale and Myoton pro.
研究概览
简要总结
Stroke is currently the leading cause of mortality in women, the second in men and the leading cause of disability in older adults. One of the most challenging sequelae after stroke is increased muscle tone due to spasticity, which alters muscle function. Functional massage therapy focuses on enhancing the function of muscles, joints, and connective tissues to improve movement and reduce pain. On the other hand, eccentric exercise, aids in the recovery of physical functions and is effective in managing spasticity improving muscle coordination and flexibility. It is essential to underline that the strength of evidence regarding these effects is considerable, supporting the implementation of these exercises in post-stroke treatment. In this context, an intervention combining functional massage with eccentric exercise on the lower limb is proposed for stroke survivors in the chronic phase. The goal of this crossover study is to analyze the effects of functional massage combined with eccentric exercise versus eccentric exercise alone on the effects of muscle tone, due to spasticity, of the lower limb in patients with chronic stroke. The Secondary Objectives are to analyze the effects of functional massage combined with eccentric exercise versus eccentric exercise alone on the improvement of ROM of the hip, knee and ankle joints, gait speed, lower limb function, quality of life and reduction of stress, anxiety and depression in patients with chronic stroke. The number of patients to be treated will be 8, the numbers of visits per patient will be 8 at the facilities of the university. Functional massage is a manual therapy technique that combines rhythmic passive mobilization of the joint, together with compression and decompression of the musculature to be treated. Eccentric exercises on lower limb focuses on movements, or phases of a movement, that lengthen the muscles. Some examples of eccentric exercise include lowering into a squat or lowering into a press-up. However, there are few previous studies combining these approaches to reduce spasticity and muscle tone and improve functionality in post-stroke patients. Participation in this study carries minimal risk, which could include events such as ankle endorses or falls during gait speed assessment or during therapeutic exercise. To mitigate these risks, participants will be allowed to use assistive devices such as splints, ankle braces, canes, or crutches during the activities selected for intervention. Importantly, patients in the chronic phase of stroke, and not in the acute phase, are included due to the stability of their condition which allows for safer and more effective participation in the study.
详细描述
According to the WHO, stroke is the second leading cause of death and the third leading cause of disability globally, with an increasing trend in both low- and middle-income countries. The estimated global cost of stroke has exceeded US$721 billion, representing 0.66% of the world's Gross Domestic Product (GDP) (1). Between 1990 and 2019, there was a substantial increase in the stroke-related burden, with a 70.0% increase in stroke cases, a 43.0% increase in stroke-attributed deaths, a 102.0% increase in prevalent stroke cases, and a 143.0% increase in Disability-Adjusted Life Years (DALYs). It is noteworthy that the majority of this burden of stroke, with 86.0% of deaths and 89.0% of DALYs, is concentrated in Low Income Countries (LMICs) and Lower Middle Income Countries (LMICs).
Ischemic stroke represents the second leading cause of death worldwide, with a total of 5.9 million deaths. However, a decrease in mortality rates has been observed in women, young people and in regions with a high sociodemographic index. The highest Standardized Mortality Rates (SMRs) and DALYs associated with ischemic stroke have been observed for women, young people and regions with a high sociodemographic index ischemic stroke are mainly concentrated in Central Europe (2). In Spain, stroke ranks first as a specific cause of mortality in women and second in men, according to data from the National Institute of Statistics (INE) (3). It is also the leading cause of disability in individuals over 65 years of age. According to INE projections for 2022, it was estimated that more than 24,000 deaths would be related to cerebrovascular diseases.
deaths were estimated to be related to cerebrovascular diseases, with more deaths in women than in men. It is important to note that, despite the decrease in the number of deaths due to cerebrovascular diseases in the last decade, the number of deaths in women is higher than in men. The last decade, the Spanish population's knowledge of stroke is still deficient (4).
Spasticity, as one of the main sequelae after stroke, occurs in approximately 30% of patients (5) and gradually worsens over time in the absence of adequate treatment, producing changes in muscle tissue such as hypertonia. Hypertonia alters motor function. It is defined as body functions related to muscle force and endurance, control over and coordination of voluntary movements, and movement patterns associated with walking, running or other whole body movements.
Likewise, mental health disorders, such as depression, stress or anxiety, are among the leading causes of disability worldwide. The three most common mental health disorders after stroke are post-stroke depression, post-stroke anxiety and post-traumatic stress disorder (6). These disorders often go undetected after a stroke and can have a significant impact on mortality rates. Recent research has shown that mental health disorders after stroke are associated with decreased functional outcomes and reduced quality of life.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes ≥ 18 years of age.
- •Adults who have been diagnosed with an ischemic or hemorrhagic stroke, according to the diagnostic criteria established by the WHO; corresponding to ICD-11 in January 2022, as confirmed by CT or MRI
- •Stroke ≥ 6 months
- •Hospital discharge
- •Stable condition
- •Ability to understand and follow simple instructions
- •Ability to read, write and speak Spanish or Catalan with acceptable visual and auditory acuity
- •Living in the Barcelona metropolitan area
- •Able to comply with scheduled visits, treatment plan, and other trial procedures
- •Increased muscle tone in Lower Extremities (EEII) according to the modified Ashworth Scale (MAS) grade ≥ 1+ <4 11) Voluntary activation capacity and muscle strength in Lower Extremities (EEII) according to Daniels Scale grade ≥ 3 12) Ability to walk 10 meters, without assistance from third parties. 13) Minimum grade of 7 in depression, 5 in anxiety and 10 in stress according to the Depression, Anxiety and Stress Scale (DASS-21).
排除标准
- •Nervous system disease and/or cardiac, pulmonary dysfunction/failure.
- •History of mental disorders and/or cognitive impairment that make it difficult or impossible to follow instructions ≤ 21 Folstein's Mini Mental Test (MMSE)
- •Hearing impairment
- •History of psychotropic drug use in the last 6 months
- •Consumption of drugs to reduce spasticity or having undergone botulinum toxin treatment in the last 3 months.
研究组 & 干预措施
Group A Functional massage in addition to eccentric exercise in paretic lower limb
Functional massage (FM) in addition to eccecntric exercises in paretic lower limb. FM is a massage technique that incorporates non-end-range joint motion (passive, active assisted or active) with massage (tissue compression) to treat musculotendinous dysfunction. During FM application, the target muscle and its surrounding soft tissues are compressed and the associated joint is moved to cause muscle lengthening or shortening. Shortening, or approximation, is used to aid the tissue in dispersing metabolic waste and improve the healing matrix of the injured tissue. Lengthening is used during the remodeling phase of tissue healing to improve mechanical strength, flexibility, and rigidity of the tissue. A combination of the two types can be used to aid in restoring the normal gliding of the connective tissue fibers during function. Eccentric resistance training is a method to improve strength and function that emphasizes the eccentric phase of the muscular contraction.
干预措施: Group A Funtional massage therapy and eccentric exercise in lower limb (Other)
Group B Eccentric exercise in paretic lower limb
Eccecntric exercises in paretic lower limb. Eccentric resistance training is a method to improve strength and function that emphasizes the eccentric phase of the muscular contraction. Some studies concluded that it allows the subject to produce more power than traditional training and to do it with a lower metabolic cost.5 It has also been reported that this type of training favors neural conduction and contributes to the prevention and improvement of health
干预措施: Group B. Eccentric exercises training (Other)
结局指标
主要结局
Muscle tone will be assessed by modified Ashworth scale and Myoton pro.
时间窗: Baseline and posttreatment at 4 weeks and at 8 weeks
Muscle tone (residual muscle tension or tonus) is the continuous and passive partial contraction of the muscles, or the muscle's resistance to passive stretch during resting state. It helps to maintain posture and declines during REM sleep.Muscle tone is regulated by the activity of the motor neurons and can be affected by various factors, including age, disease, and nerve damage as spasticity. Modified Ashworth scale is performed by extending the patients limb's first from a position of maximal flexion to maximal extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. 0 is no increase in tone and 4 limb rigid in flexion or extension. The Myoton recording of dynamic tissue response in the form of physical displacement and oscillation acceleration signal and the subsequent computation of parameters characterizing the State of Tension, Biomechanical and Viscoelastic properties.
次要结局
- Range of Motion (ROM) of the hip, knee and foot joints will be assessed by inclinometer.(Baseline and posttreatment at 4 weeks and at 8 weeks)
- Gait speed will be assessed by 4 meters walking test at confortable pace and maximum pace.(Baseline and posttreatment at 4 weeks and at 8 weeks)
- Functionality of lower limb will be assessed by 30 seconds sit-to-stand and lower limb Fugl meyer scale(Baseline and posttreatment at 4 weeks and at 8 weeks)
- Self-perceived emotional burden like stress, anxiety and depression will be assessed by Depression, Anxiety and Stress Scale-21 (DASS-21)(Baseline and posttreatment at 4 weeks and at 8 weeks)
- Quality of life and health status will be assessed by EuroQoL-5D-5L.(Baseline and posttreatment at 4 weeks and at 8 weeks)
研究者
Rosa Cabanas Valdés
Rosa Cabanas Valdés
Universitat Internacional de Catalunya