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.

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

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Diagnostic test: 3DfUS and IPSA of leg muscles

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 Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults with first ever chronic stroke:

= First ever stroke subjects with established spasticity and without spasticity will be recruited on the stroke rehabilitation unit and outpatient rehabilitation clinic, University Hospital of Leuven.

Healthy control subjects

= Healthy age-and gender matched subjects will be recruited among healthy university staff of the University Hospital of Leuven, their family and friends.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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: clinical functional capacity
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: clinical functional capacity
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: clinical functional capacity

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify the impairment caused by a stroke	Evaluation of impairment caused by stroke by National Institute Health Stroke Scale	1 day
Assessments of functional independence in daily life in stroke patients and healthy subjects	Evaluation of functional independence in daily life is assessed by the Barthel Index	1 day
Assessments of functional status after stroke	Evaluation of functional status after stroke is assessed by the Functional Independence Measure	1 day
Assessesment of mobility in stroke patients	Evaluation of mobility after stroke is assessed by the Rivermead Mobility Index	1 day
Assessment of transfer skills in stroke patients and healthy subjects	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	1 day
Assessment of the motor impairment in lower limbs of stroke patients	Measurement of lower limb strength in stroke patients by the Motricity Index	1 day
Assessments of gait speed analysis in stroke patients and healthy subjects.	1 day	Measurement of gait speed in stroke patients and healthy subjects by 5-Meter Walk Test at comfortable or self-selected gait speed.

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Fabienne Schillebeeckx, MD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: S60153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No