Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident

Cerebrovascular Accident Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607486
• Other study ID #: S60153
• Status: Completed
• Start date: June 18, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantify the impairment caused by a stroke	Evaluation of impairment caused by stroke by National Institute Health Stroke Scale	1 day
Other	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
Other	Assessments of functional status after stroke	Evaluation of functional status after stroke is assessed by the Functional Independence Measure	1 day
Other	Assessesment of mobility in stroke patients	Evaluation of mobility after stroke is assessed by the Rivermead Mobility Index	1 day
Other	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
Other	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
Other	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.
Primary	Muscle volume	Estimation of muscle volume by 3D freehand ultrasonography.	1 day
Primary	Muscle and Tendon Length	Estimation of muscle volume by 3D freehand ultrasonography	1 day
Primary	Echogenicity intensity	Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).	1 day
Primary	Work [J] derived from the slow stretch	Measurement of Work [J] by Instrumented Spasticity Assessment	1 day
Primary	Muscle activity EMG [uV] derived from the fast stretch	Measurement of Muscle activity EMG [uV] by Instrumented Spasticity Assessment	1 day
Primary	Maximal velocity of performance (Vmax [deg/s])	Measurement of Maximal velocity of performance (Vmax [deg/s]) by Instrumented Spasticity Assessment	1 day
Primary	Range of motion [deg] for slow stretch	Measurement of Range of motion [deg] by Instrumented Spasticity Assessment	1 day
Primary	Stiffness [Nm/deg] for slow stretch	Measurement of Stiffness [Nm/deg] by Instrumented Spasticity Assessment	1 day
Primary	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
Primary	Angle of EMG threshold [deg] from the fast stretch	Measurement of Angle of EMG threshold [deg] by Instrumented Spasticity Assessment	1 day
Primary	Intensity of catch derived from the fast stretch	Measurement of Intensity of catch by Instrumented Spasticity Assessment	1 day
Secondary	Clinical assessment of spasticity at fast stretch	Estimation of spasticity by Modified Assessment Scale	1 day
Secondary	Clinical assessment of spasticity angle at slow and fast stretch	Estimation of spasticity by Tardieu Scale	1 day