Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident

Study Overview
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Brief Summary
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The aim of this study is to investigate lower limb muscles after cerebrovascular accident

Detailed Description
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The aim of this study is to define and differentiate the changes in MMT properties related to the alterations in muscle tone of the lower limb in first-ever chronic stroke patients by using a 3D free-hand Ultrasonography (3DfUS) technique in combination with an instrumented spasticity assessment (IPSA). In these chronic stroke patients, the spontaneous neurological recovery is stabilized

Official Title
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Reliability Study of a 3D Free-hand Ultrasonography Technique (3DfUS) in Combination With Instrumented Spasticity Assessment (ISA) for the Lower Limb in Chronic First-ever Stroke Patients.

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Diagnostic Test: 3DfUS and IPSA of leg muscles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Definition of case population : o first ever stroke with spasticity of the lower limb. Definition of control : first ever stroke without spasticity of the lower limb healthy aged-matched subjects Exclusion Criteria: Musculoskeletal or neurological problems affecting the lower limb Presence of other neurological pathology that could lead to spasticity, ataxia, dystonia Cognitive problems that impede measurements Severe co-morbidities Peripheral spastic medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CVA and spasticity<br>Adults with first-ever chronic CVA and leg spasticity | Diagnostic Test: 3DfUS and IPSA of leg muscles<br>* 3DfUS technique enhances a conventional 2D US device into a platform capable of reconstructing 3D anatomical data sets. IPSA for quantification of hyper-resistance and its underlying components. The sensors in the IPSa include gyroscopes and accelerometers to measure joint angle and angular velocity, EMG to measure muscle activity, and a 3 degrees-of freedom force sensor to measure torque applied on the joint. clinical functional capacity = clinical evaluation of degree of independence, mobility and gait<br>* Other names: clinical functional capacity;|
| CVA without spasticity<br>Control group | Diagnostic Test: 3DfUS and IPSA of leg muscles<br>* 3DfUS technique enhances a conventional 2D US device into a platform capable of reconstructing 3D anatomical data sets. IPSA for quantification of hyper-resistance and its underlying components. The sensors in the IPSa include gyroscopes and accelerometers to measure joint angle and angular velocity, EMG to measure muscle activity, and a 3 degrees-of freedom force sensor to measure torque applied on the joint. clinical functional capacity = clinical evaluation of degree of independence, mobility and gait<br>* Other names: clinical functional capacity;|
| healthy subjects<br>Control group | Diagnostic Test: 3DfUS and IPSA of leg muscles<br>* 3DfUS technique enhances a conventional 2D US device into a platform capable of reconstructing 3D anatomical data sets. IPSA for quantification of hyper-resistance and its underlying components. The sensors in the IPSa include gyroscopes and accelerometers to measure joint angle and angular velocity, EMG to measure muscle activity, and a 3 degrees-of freedom force sensor to measure torque applied on the joint. clinical functional capacity = clinical evaluation of degree of independence, mobility and gait<br>* Other names: clinical functional capacity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle volume | Estimation of muscle volume by 3D freehand ultrasonography. | 1 day | 
| Muscle and Tendon Length | Estimation of muscle volume by 3D freehand ultrasonography | 1 day | 
| Echogenicity intensity | Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values). | 1 day | 
| Work [J] derived from the slow stretch | Measurement of Work [J] by Instrumented Spasticity Assessment | 1 day | 
| Muscle activity EMG [uV] derived from the fast stretch | Measurement of Muscle activity EMG [uV] by Instrumented Spasticity Assessment | 1 day | 
| Maximal velocity of performance (Vmax [deg/s]) | Measurement of Maximal velocity of performance (Vmax [deg/s]) by Instrumented Spasticity Assessment | 1 day | 
| Range of motion [deg] for slow stretch | Measurement of Range of motion [deg] by Instrumented Spasticity Assessment | 1 day | 
| Stiffness [Nm/deg] for slow stretch | Measurement of Stiffness [Nm/deg] by Instrumented Spasticity Assessment | 1 day | 
| Joint angle of catch [deg] from the fast stretch | Measurement of Joint angle of catch [deg] from the fast stretch by Instrumented Spasticity Assessment | 1 day | 
| Angle of EMG threshold [deg] from the fast stretch | Measurement of Angle of EMG threshold [deg] by Instrumented Spasticity Assessment | 1 day | 
| Intensity of catch derived from the fast stretch | Measurement of Intensity of catch by Instrumented Spasticity Assessment | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of spasticity at fast stretch | Estimation of spasticity by Modified Assessment Scale | 1 day | 
| Clinical assessment of spasticity angle at slow and fast stretch | Estimation of spasticity by Tardieu Scale | 1 day |