Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident

Completed

• Conditions: Cerebrovascular Accident
• Interventions: Diagnostic Test: 3DfUS and IPSA of leg muscles

• Registration Number: NCT04607486
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Study Timeline

• Study Start: 2018-06-18
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-29
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CVA without spasticity	3DfUS and IPSA of leg muscles	Control group
CVA and spasticity	3DfUS and IPSA of leg muscles	Adults with first-ever chronic CVA and leg spasticity
healthy subjects	3DfUS and IPSA of leg muscles	Control group

Primary Outcome Measures

Name	Time	Method
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
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
Muscle volume	1 day	Estimation of muscle volume by 3D freehand ultrasonography.
Maximal velocity of performance (Vmax [deg/s])	1 day	Measurement of Maximal velocity of performance (Vmax \[deg/s\]) 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
Range of motion [deg] for slow stretch	1 day	Measurement of Range of motion \[deg\] by Instrumented Spasticity Assessment

Secondary Outcome Measures

Name	Time	Method
Clinical assessment of spasticity angle at slow and fast stretch	1 day	Estimation of spasticity by Tardieu Scale
Clinical assessment of spasticity at fast stretch	1 day	Estimation of spasticity by Modified Assessment Scale

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium