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Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04607486
Enrollment
76
Registered
2020-10-29
Start date
2018-06-18
Completion date
2023-12-30
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

Brief summary

The aim of this study is to investigate lower limb muscles after cerebrovascular accident

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

Interventions

DIAGNOSTIC_TEST3DfUS and IPSA of leg muscles

1. 3DfUS technique enhances a conventional 2D US device into a platform capable of reconstructing 3D anatomical data sets. 2. 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. 3. clinical functional capacity = clinical evaluation of degree of independence, mobility and gait

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intensity of catch derived from the fast stretch1 dayMeasurement of Intensity of catch by Instrumented Spasticity Assessment
Muscle and Tendon Length1 dayEstimation of muscle volume by 3D freehand ultrasonography
Echogenicity intensity1 dayEstimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
Work [J] derived from the slow stretch1 dayMeasurement of Work \[J\] by Instrumented Spasticity Assessment
Muscle activity EMG [uV] derived from the fast stretch1 dayMeasurement of Muscle activity EMG \[uV\] by Instrumented Spasticity Assessment
Maximal velocity of performance (Vmax [deg/s])1 dayMeasurement of Maximal velocity of performance (Vmax \[deg/s\]) by Instrumented Spasticity Assessment
Range of motion [deg] for slow stretch1 dayMeasurement of Range of motion \[deg\] by Instrumented Spasticity Assessment
Stiffness [Nm/deg] for slow stretch1 dayMeasurement of Stiffness \[Nm/deg\] by Instrumented Spasticity Assessment
Joint angle of catch [deg] from the fast stretch1 dayMeasurement of Joint angle of catch \[deg\] from the fast stretch by Instrumented Spasticity Assessment
Angle of EMG threshold [deg] from the fast stretch1 dayMeasurement of Angle of EMG threshold \[deg\] by Instrumented Spasticity Assessment
Muscle volume1 dayEstimation of muscle volume by 3D freehand ultrasonography.

Secondary

MeasureTime frameDescription
Clinical assessment of spasticity angle at slow and fast stretch1 dayEstimation of spasticity by Tardieu Scale
Clinical assessment of spasticity at fast stretch1 dayEstimation of spasticity by Modified Assessment Scale

Other

MeasureTime frameDescription
Assessesment of mobility in stroke patients1 dayEvaluation of mobility after stroke is assessed by the Rivermead Mobility Index
Assessment of transfer skills in stroke patients and healthy subjects1 dayMeasurement 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 patients1 dayMeasurement 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
Assessments of functional independence in daily life in stroke patients and healthy subjects1 dayEvaluation of functional independence in daily life is assessed by the Barthel Index
Quantify the impairment caused by a stroke1 dayEvaluation of impairment caused by stroke by National Institute Health Stroke Scale
Assessments of functional status after stroke1 dayEvaluation of functional status after stroke is assessed by the Functional Independence Measure

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026