Analysis of the Correlation Between Ultrasound Imaging and Functional Parameters in the Medial Gastrocnemius Muscle in Post-stroke Patients With Spasticity in the Lower Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Muscle thickness
研究概览
简要总结
The goal of this observational study is to understand the impact of spasticity on muscle changes and functional performance in stroke patients with lower limb spasticity in comparison to non-stroke individuals. The main questions it aims to answer are:
- How does spasticity affect muscle changes and lower limb functional performance in stroke patients?
- How do structural and textural parameters in ultrasound images differ between spastic stroke patients and non-stroke individuals?
Participants will undergo ultrasound evaluation of their leg muscles to measure structural and textural parameters. They will also take part in functional assessments to assess their performance in activities related to lower limb mobility.
Researchers will compare the structural and textural ultrasound parameters between stroke patients and non-stroke individuals to determine any notable differences. The study aims to identify the relationship between muscle changes, spasticity, and functional performance in stroke patients.
详细描述
Cerebrovascular Accident (CVA) or stroke is one of the leading causes of morbidity and disability worldwide. Spasticity is a common complication in patients with CVA, affecting between 43.2% and 49.5% of patients in the first six months. It can interfere with movement and cause discomfort, pain, joint contracture, and abnormal limb posture. Ankle spasticity is particularly problematic for gait recovery.
Computed tomography (CT) and magnetic resonance imaging (MRI) are considered the gold standard for measuring muscle mass, but their use is not practical due to patient discomfort, radiation exposure, and high costs. Ultrasound is presented as an effective and low-cost tool for evaluating muscle tissues.
Previous research has analyzed architectural changes in spastic muscles in hemiplegic patients and found conflicting results regarding muscle thickness and fascicle length. Further studies are needed to better understand the relationship between muscle changes and weakness, spasticity, and functional performance of the lower limbs.
This study aims to analyze the relationship between muscular architecture and echotexture parameters, and the functional parameters of the medial gastrocnemius muscle in patients with spasticity in the lower limb after a stroke and compare them with non-stroke subjects.
Comparing the affected side with the supposedly healthy side of stroke patients will allow for a better understanding of the structural changes that occur on both sides.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years
- •Present spasticity in the plantar flexor muscles of the ankle as a result of a first unilateral ischemic or hemorrhagic stroke (excluding subarachnoid hemorrhage, as it is not truly a stroke) diagnosed by computed tomography or magnetic resonance imaging.
- •Have more than 6 months of evolution since the onset of the cerebrovascular accident (chronic stroke).
- •Degree of spasticity on the Modified Ashworth Scale (MAS): 1, 1+, 2, or
- •Be able to walk independently with or without assistance.
排除标准
- •Other musculoskeletal or neurological disorders affecting the lower limb (bilateral stroke, peripheral neuropathy, peripheral nerve injury, myopathy, severe osteoarthritis, recent muscle injury, recent bone fracture, joint replacement, fixed contractures involving the affected leg, bone deformities of the lower limbs).
- •Other neurological pathologies (e.g., ataxia or dystonia).
- •Surgical intervention in the lower limb.
- •Cognitive impairments that hinder study measurements.
- •Other medical conditions that may interfere with data interpretation.
- •Group of non-stroke patients
- •Inclusion Criteria:
- •Age over 18 years
- •Be able to walk independently with or without assistance
- •Exclusion Criteria:
- •Previous diagnosis of stroke.
- •Presence of spasticity in any part of the body.
- •Other musculoskeletal or neurological disorders affecting the lower limb (bilateral stroke, peripheral neuropathy, peripheral nerve injury, myopathy, severe osteoarthritis, recent muscle injury, recent bone fracture, joint replacement, fixed contractures involving the affected leg, bone deformities of the lower limbs).
- •Other neurological pathologies (e.g., ataxia or dystonia).
- •Surgical intervention in the lower limb.
- •Cognitive impairments that hinder study measurements.
- •Other medical conditions that may interfere with data interpretation.
结局指标
主要结局
Muscle thickness
时间窗: Through study completion, an average of 1 year
It is the distance between the superficial and deep layer of the fascia of the medial gastrocnemius. It is considered one of the 3 muscular architecture parameters that will be measured using ultrasound images collected with the Butterfly iQ+ portable device by Butterfly Network, Inc., a company located in the United Kingdom. The device is connected to a tablet from which the images are visualized and captured. For more information about the device, you can visit the following link: www.butterflynetwork.com/int/es-es/individual
次要结局
- Fascicle length(Through study completion, an average of 1 year)
- Concurrence matrices(Through study completion, an average of 1 year)
- Contraction velocity, relaxation velocity, and shrinkage potential(Through study completion, an average of 1 year)
- Degree of spasticity(Through study completion, an average of 1 year)
- Functional capacity(Through study completion, an average of 1 year)
- Muscle strength(Through study completion, an average of 1 year)
- Pennation angle(Through study completion, an average of 1 year)
研究者
Dr. Pablo Herrero Gallego
Professor and PhD
Universidad de Zaragoza