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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:
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.
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.
Studying structural changes in patients with chronic spasticity after a stroke can help healthcare professionals better understand the impact of this condition on muscle function and develop personalized treatment plans. Ultrasound can be a useful tool to improve the effectiveness of rehabilitation interventions in stroke survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with stroke | Patients with a chronic stroke and spasticity in the ankle flexors muscles. |
| |
| Patients without stroke | Patients without stroke were matched with those with stroke based on age and sex. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound imaging and functional assessment | Diagnostic Test | Participants in this study will undergo two types of assessments: capturing muscle images using ultrasound and evaluating their function through clinical scales. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle thickness | 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 | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Fascicle length | It is the estimation of the length of the muscle fiber, which is obtained by tracing a line that covers the length of the muscle fascicle between the deep and superficial aponeuroses. | Through study completion, an average of 1 year |
| Pennation angle |
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Group of patients diagnosed with ischemic or hemorrhagic stroke.
Inclusion Criteria:
Exclusion Criteria:
Group of non-stroke patients
Inclusion Criteria:
Exclusion Criteria:
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Stroke group: patients diagnosed with ischemic or hemorrhagic stroke who follow the selection criteria.
Non-stroke group: patients without a diagnosis of stroke matching with each member of the stroke group.
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Herrero Gallego, Physical Therapist | Universidad de Zaragoza | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Zaragoza | Zaragoza | Aragon | 50009 | Spain |
The team is still figure it out what is the best way to share the information.
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It is the angle between the deep fascia and the line of the fascicle length. |
| Through study completion, an average of 1 year |
| Concurrence matrices | Measures that describe the spatial distribution of gray levels in the texture of an ultrasound image. These matrices, also known as co-occurrence matrices, are used to analyze textural features and patterns in ultrasound images. | Through study completion, an average of 1 year |
| Degree of spasticity | It will be measured using the Modified Ashworth Scale (MAS). The scale ranges from a minimum value of 0 to a maximum of 4, with 0 indicating no spasticity and 4 representing the most severe spasticity, characterized by complete rigidity. | Through study completion, an average of 1 year |
| Functional capacity | Measured by Time Up and Go (TUG) | Through study completion, an average of 1 year |
| Functional capacity | Measured by 10 Meter Walk Test (10MWT) | Through study completion, an average of 1 year |
| Muscle strength | Maximum isometric contractions will be measured using dynamometry. | Through study completion, an average of 1 year |
| Contraction velocity, relaxation velocity, and shrinkage potential | The Movement mode will be used to calculate these parameters simultaneously taken the force using dynamometry. This will allow correlating the Modo M with force. | Through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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