Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident

NCT ID: NCT04607486

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-18

Study Completion Date

2023-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebrovascular Accident

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CVA and spasticity

Adults with first-ever chronic CVA and leg spasticity

3DfUS and IPSA of leg muscles

Intervention Type DIAGNOSTIC_TEST

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

CVA without spasticity

Control group

3DfUS and IPSA of leg muscles

Intervention Type DIAGNOSTIC_TEST

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

healthy subjects

Control group

3DfUS and IPSA of leg muscles

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3DfUS 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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

clinical functional capacity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fabienne Schillebeeckx, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Leuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S60153

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognition and Motor Learning Post-stroke
NCT04829071 RECRUITING EARLY_PHASE1