Cerebrovascular AccidentNCT04607486
Investigation of Changes in Lower Limb Muscles After Cerebrovascular Accident
An observational study of Cerebrovascular Accident, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to investigate lower limb muscles after cerebrovascular accident Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- 3DfUS and IPSA of leg muscles
- How many people
- 76 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jun 2018to 30 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
The aim of this study is to investigate lower limb muscles after cerebrovascular accident
Read the 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
- Conditions
- Cerebrovascular Accident
- Being tested
- 3DfUS and IPSA of leg muscles
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DfUS and IPSA of leg musclesDiagnostic test
Also called clinical functional capacity
- 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
| Study group | Role | What they receive |
|---|---|---|
| CVA and spasticity | Adults with first-ever chronic CVA and leg spasticity Receives: Diagnostic Test: 3DfUS and IPSA of leg muscles | |
| CVA without spasticity | Control group Receives: Diagnostic Test: 3DfUS and IPSA of leg muscles | |
| healthy subjects | Control group Receives: Diagnostic Test: 3DfUS and IPSA of leg muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle volume
Estimation of muscle volume by 3D freehand ultrasonography.
Measured: 1 day
Muscle and Tendon Length
Estimation of muscle volume by 3D freehand ultrasonography
Measured: 1 day
Echogenicity intensity
Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
Measured: 1 day
Work [J] derived from the slow stretch
Measurement of Work [J] by Instrumented Spasticity Assessment
Measured: 1 day
Muscle activity EMG [uV] derived from the fast stretch
Measurement of Muscle activity EMG [uV] by Instrumented Spasticity Assessment
Measured: 1 day
Maximal velocity of performance (Vmax [deg/s])
Measurement of Maximal velocity of performance (Vmax [deg/s]) by Instrumented Spasticity Assessment
Measured: 1 day
Range of motion [deg] for slow stretch
Measurement of Range of motion [deg] by Instrumented Spasticity Assessment
Measured: 1 day
Stiffness [Nm/deg] for slow stretch
Measurement of Stiffness [Nm/deg] by Instrumented Spasticity Assessment
Measured: 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
Measured: 1 day
Angle of EMG threshold [deg] from the fast stretch
Measurement of Angle of EMG threshold [deg] by Instrumented Spasticity Assessment
Measured: 1 day
Intensity of catch derived from the fast stretch
Measurement of Intensity of catch by Instrumented Spasticity Assessment
Measured: 1 day
Secondary outcomes (2)
Clinical assessment of spasticity at fast stretch
Estimation of spasticity by Modified Assessment Scale
Measured: 1 day
Clinical assessment of spasticity angle at slow and fast stretch
Estimation of spasticity by Tardieu Scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start18 Jun 2018
- Primary completion31 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Schillebeeckx, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607486
- Sponsor's protocol ID
- S60153
- Status last verified
- May 2024
- First submitted
- 6 Aug 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04607486
- Acronym / sponsor ID
- S60153
- Conditions
- Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CVA and spasticity | – | Diagnostic Test: 3DfUS and IPSA of leg musclesAdults with first-ever chronic CVA and leg spasticity |
| CVA without spasticity | – | Diagnostic Test: 3DfUS and IPSA of leg musclesControl group |
| healthy subjects | – | Diagnostic Test: 3DfUS and IPSA of leg musclesControl group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Definition of case population :
- o first ever stroke with spasticity of the lower limb.
- Definition of control :
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3DfUS and IPSA of leg musclesAlso: clinical functional capacity1. 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 | Diagnostic test | CVA and spasticity, CVA without spasticity, healthy subjects |
Primary outcome
Muscle volume
Time frame: 1 day
Estimation of muscle volume by 3D freehand ultrasonography.
Muscle and Tendon Length
Time frame: 1 day
Estimation of muscle volume by 3D freehand ultrasonography
Echogenicity intensity
Time frame: 1 day
Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
Work [J] derived from the slow stretch
Time frame: 1 day
Measurement of Work [J] by Instrumented Spasticity Assessment
Muscle activity EMG [uV] derived from the fast stretch
Time frame: 1 day
Measurement of Muscle activity EMG [uV] by Instrumented Spasticity Assessment
Maximal velocity of performance (Vmax [deg/s])
Time frame: 1 day
Measurement of Maximal velocity of performance (Vmax [deg/s]) by Instrumented Spasticity Assessment
Range of motion [deg] for slow stretch
Time frame: 1 day
Measurement of Range of motion [deg] by Instrumented Spasticity Assessment
Stiffness [Nm/deg] for slow stretch
Time frame: 1 day
Measurement of Stiffness [Nm/deg] by Instrumented Spasticity Assessment
Joint angle of catch [deg] from the fast stretch
Time frame: 1 day
Measurement of Joint angle of catch [deg] from the fast stretch by Instrumented Spasticity Assessment
Angle of EMG threshold [deg] from the fast stretch
Time frame: 1 day
Measurement of Angle of EMG threshold [deg] by Instrumented Spasticity Assessment
Intensity of catch derived from the fast stretch
Time frame: 1 day
Measurement of Intensity of catch by Instrumented Spasticity Assessment
2 secondary outcomes
Clinical assessment of spasticity at fast stretch
Time frame: 1 day
Clinical assessment of spasticity angle at slow and fast stretch
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
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Music Therapy in Post-Stroke Patients: A Clinical Trial
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RESPARK - Brain Q for Chronic Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Schillebeeckx, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle volume (time frame: 1 day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.