Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident
Study Details
Study Description
Brief Summary
The aim of this study is to investigate lower limb muscles after cerebrovascular accident
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CVA and spasticity Adults with first-ever chronic CVA and leg spasticity |
Diagnostic Test: 3DfUS and IPSA of leg muscles
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
Other Names:
|
| CVA without spasticity Control group |
Diagnostic Test: 3DfUS and IPSA of leg muscles
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
Other Names:
|
| healthy subjects Control group |
Diagnostic Test: 3DfUS and IPSA of leg muscles
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Muscle volume [1 day]
Estimation of muscle volume by 3D freehand ultrasonography.
- Muscle and Tendon Length [1 day]
Estimation of muscle volume by 3D freehand ultrasonography
- Echogenicity intensity [1 day]
Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
- Work [J] derived from the slow stretch [1 day]
Measurement of Work [J] by Instrumented Spasticity Assessment
- Muscle activity EMG [uV] derived from the fast stretch [1 day]
Measurement of Muscle activity EMG [uV] by Instrumented Spasticity Assessment
- Maximal velocity of performance (Vmax [deg/s]) [1 day]
Measurement of Maximal velocity of performance (Vmax [deg/s]) by Instrumented Spasticity Assessment
- Range of motion [deg] for slow stretch [1 day]
Measurement of Range of motion [deg] by Instrumented Spasticity Assessment
- Stiffness [Nm/deg] for slow stretch [1 day]
Measurement of Stiffness [Nm/deg] by Instrumented Spasticity Assessment
- Joint angle of catch [deg] from the fast stretch [1 day]
Measurement of Joint angle of catch [deg] from the fast stretch by Instrumented Spasticity Assessment
- Angle of EMG threshold [deg] from the fast stretch [1 day]
Measurement of Angle of EMG threshold [deg] by Instrumented Spasticity Assessment
- Intensity of catch derived from the fast stretch [1 day]
Measurement of Intensity of catch by Instrumented Spasticity Assessment
Secondary Outcome Measures
- Clinical assessment of spasticity at fast stretch [1 day]
Estimation of spasticity by Modified Assessment Scale
- Clinical assessment of spasticity angle at slow and fast stretch [1 day]
Estimation of spasticity by Tardieu Scale
Other Outcome Measures
- Quantify the impairment caused by a stroke [1 day]
Evaluation of impairment caused by stroke by National Institute Health Stroke Scale
- Assessments of functional independence in daily life in stroke patients and healthy subjects [1 day]
Evaluation of functional independence in daily life is assessed by the Barthel Index
- Assessments of functional status after stroke [1 day]
Evaluation of functional status after stroke is assessed by the Functional Independence Measure
- Assessesment of mobility in stroke patients [1 day]
Evaluation of mobility after stroke is assessed by the Rivermead Mobility Index
- Assessment of transfer skills in stroke patients and healthy subjects [1 day]
Measurement of functional lower extremity strength and/or identify movement strategies in stroke patients and healthy subjects by The Five Times Sit to Stand Test
- Assessment of the motor impairment in lower limbs of stroke patients [1 day]
Measurement of lower limb strength in stroke patients by the Motricity Index
- Assessments of gait speed analysis in stroke patients and healthy subjects. [Measurement of gait speed in stroke patients and healthy subjects by 5-Meter Walk Test at comfortable or self-selected gait speed.]
1 day
Eligibility Criteria
Criteria
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
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Severe co-morbidities
-
Peripheral spastic medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Fabienne Schillebeeckx, MD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S60153