StrokeStroke_DynUSNCT06250478
Dynamic Ultrasound of the Calf Muscles After Stroke
A study testing Dynamic ultrasound of the calf muscles in people with Stroke and Gait Disorders, Neurologic, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Muscle behaviour of calf muscles can be studied during dynamic conditions using dynamic ultrasound. In particular, the medial gastrocnemius is suitable for measurements with dynamic ultrasound due to its superficial location. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Gait Disorders, Neurologic
- What is being tested?
- Dynamic ultrasound of the calf muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Feb 2024to 4 Apr 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- wearing ankle foot orthosis that inhibit the assessment
- had lower limb surgery in the past
- Healthy volunteers Inclusion criteria
- healthy adults
- suffering from any neurological condition
- had lower limb surgery in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Het Gebruik Van Dynamische Echografie om Spier-pees Veranderingen te Onderzoeken in de Kuitspieren Van Personen na Een CVA: Een Pilootstudie
Muscle behaviour of calf muscles can be studied during dynamic conditions using dynamic ultrasound. In particular, the medial gastrocnemius is suitable for measurements with dynamic ultrasound due to its superficial location. With this measurement technique, the muscle behavior during walking can be observed gaining insight into the mechanism of action of this muscle during a functional task. This technique has already been used in other populations (such as children with cerebral palsy) but not yet in individuals after a stroke.
Therefore, the aim of this study is to assess the muscle behavior of the medial gastrocnemius during walking in persons after stroke. There are 3 concrete objectives of the current study:
Read more
- is the technique feasible to perform in persons after stroke?
- does the use of the dynamic echoprobe change gait patterns?
- can differences between persons after stroke and healthy controls be detected? This data can be used as pilot data for project applications in the future that will allow to design larger studies.
Therefore, 10 stroke patients and 10 age- and gender-matched healthy controls will walk on a treadmill for 3x2 minutes after a familiarisation period of 6 minutes.
During 1 x 2 minutes, subjects will walk without using the dynamic ultrasound. This recording aims to measure the normal gait pattern of the subjects.
During the other 2x2 minutes, subjects will walk using the dynamic ultrasound at 2 different locations on the calf. Once with the ultrasound probe on the centre of the muscle belly to visualise muscle fibre bundles and once on the muscle tendon transition, from which muscle belly and tendon length can be derived.
The use of ultrasound or not will be randomized to exclude the effect of fatigue on the outcome measures.
- Conditions
- Stroke, Gait Disorders, Neurologic
- Being tested
- Dynamic ultrasound of the calf muscles
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic ultrasound of the calf musclesDiagnostic test
Dynamic changes of the calf muscles during walking will be assessed in persons after stroke and compared to healthy controls
| Study group | Role | What they receive |
|---|---|---|
| Stroke patient | Experimental | Not described Receives: Diagnostic Test: Dynamic ultrasound of the calf muscles |
| Healthy controls | Active comparator | Not described Receives: Diagnostic Test: Dynamic ultrasound of the calf muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fascicle dynamics measured with ultrasound during walking
Lengthening and shortening of the fascicles of the medial gastrocnemius
Measured: single point assessment in one day during walking with the probe
Muscle belly dynamics measured with ultrasound during walking
Lengthening and shortening of the muscle belly of the medial gastrocnemius
Measured: single point assessment in one day during walking with the probe
Tendon dynamics measured with ultrasound during walking
Lengthening and shortening of the tendon of the medial gastrocnemius
Measured: single point assessment in one day during walking with the probe
Secondary outcomes (12)
gait speed
walking velocity (m/s)
Measured: single point assessment in one day during walking with the probe
gait speed
walking velocity (m/s)
Measured: single point assessment in one day during walking without the probe
step width
step width (m)
Measured: single point assessment in one day during walking with the probe
step width
step width (m)
Measured: single point assessment in one day during walking without the probe
Step length
Step length (m) of the paretic and non paretic side
Measured: single point assessment in one day during walking with the probe
Step length
Step length (m) of the paretic and non paretic side
Measured: single point assessment in one day during walking without the probe
stance phase
time spend standing on the paretic and non-paretic leg (s) during walking
Measured: single point assessment in one day during walking with the probe
stance phase
time spend standing on the paretic and non-paretic leg (s) during walking
Measured: single point assessment in one day during walking without the probe
swing phase
time spend not standing on the paretic and non-paretic leg (s) during walking
Measured: single point assessment in one day during walking with the probe
swing phase
time spend not standing on the paretic and non-paretic leg (s) during walking
Measured: single point assessment in one day during walking without the probe
lower limb kinematics
joint angles (°) in the pelvis, hip, knee and ankle in the sagittal, frontal and transverse plane during walking
Measured: single point assessment in one day during walking with the probe
lower limb kinematics
joint angles (°) in the pelvis, hip, knee and ankle in the sagittal, frontal and transverse plane during walking
Measured: single point assessment in one day during walking without the probe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start27 Feb 2024
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Both stroke patients and age and gender matched healthy controls will be included
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250478
- Sponsor's protocol ID
- ONZ-2023-0497
- Other IDs
- B6702023000632
- Acronym
- Stroke_DynUS
- Status last verified
- Jun 2024
- First submitted
- 17 Jan 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Het Gebruik Van Dynamische Echografie om Spier-pees Veranderingen te Onderzoeken in de Kuitspieren Van Personen na Een CVA: Een Pilootstudie
- ClinicalTrials.gov ID
- NCT06250478
- Acronym / sponsor ID
- Stroke_DynUS / ONZ-2023-0497
- Conditions
- Stroke, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 9 Feb 2024 (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.
Muscle behaviour of calf muscles can be studied during dynamic conditions using dynamic ultrasound. In particular, the medial gastrocnemius is suitable for measurements with dynamic ultrasound due to its superficial location. With this measurement technique, the muscle behavior during walking can be observed gaining insight into the mechanism of action of this muscle during a functional task. This technique has already been used in other populations (such as children with cerebral palsy) but not yet in individuals after a stroke.
Therefore, the aim of this study is to assess the muscle behavior of the medial gastrocnemius during walking in persons after stroke. There are 3 concrete objectives of the current study:
- is the technique feasible to perform in persons after stroke?
- does the use of the dynamic echoprobe change gait patterns?
- can differences between persons after stroke and healthy controls be detected? This data can be used as pilot data for project applications in the future that will allow to design larger studies.
Therefore, 10 stroke patients and 10 age- and gender-matched healthy controls will walk on a treadmill for 3x2 minutes after a familiarisation period of 6 minutes.
During 1 x 2 minutes, subjects will walk without using the dynamic ultrasound. This recording aims to measure the normal gait pattern of the subjects.
During the other 2x2 minutes, subjects will walk using the dynamic ultrasound at 2 different locations on the calf. Once with the ultrasound probe on the centre of the muscle belly to visualise muscle fibre bundles and once on the muscle tendon transition, from which muscle belly and tendon length can be derived.
The use of ultrasound or not will be randomized to exclude the effect of fatigue on the outcome measures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both stroke patients and age and gender matched healthy controls will be included
| Arm | Type | Receives |
|---|---|---|
| Stroke patient | Experimental | Diagnostic Test: Dynamic ultrasound of the calf muscles |
| Healthy controls | Active comparator | Diagnostic Test: Dynamic ultrasound of the calf muscles |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- wearing ankle foot orthosis that inhibit the assessment
- had lower limb surgery in the past
- Healthy volunteers Inclusion criteria
- healthy adults
- suffering from any neurological condition
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 |
|---|---|---|
| Dynamic ultrasound of the calf musclesDynamic changes of the calf muscles during walking will be assessed in persons after stroke and compared to healthy controls | Diagnostic test | Healthy controls, Stroke patient |
Primary outcome
Fascicle dynamics measured with ultrasound during walking
Time frame: single point assessment in one day during walking with the probe
Lengthening and shortening of the fascicles of the medial gastrocnemius
Muscle belly dynamics measured with ultrasound during walking
Time frame: single point assessment in one day during walking with the probe
Lengthening and shortening of the muscle belly of the medial gastrocnemius
Tendon dynamics measured with ultrasound during walking
Time frame: single point assessment in one day during walking with the probe
Lengthening and shortening of the tendon of the medial gastrocnemius
12 secondary outcomes
gait speed
Time frame: single point assessment in one day during walking with the probe
gait speed
Time frame: single point assessment in one day during walking without the probe
step width
Time frame: single point assessment in one day during walking with the probe
step width
Time frame: single point assessment in one day during walking without the probe
Step length
Time frame: single point assessment in one day during walking with the probe
Step length
Time frame: single point assessment in one day during walking without the probe
stance phase
Time frame: single point assessment in one day during walking with the probe
stance phase
Time frame: single point assessment in one day during walking without the probe
swing phase
Time frame: single point assessment in one day during walking with the probe
swing phase
Time frame: single point assessment in one day during walking without the probe
lower limb kinematics
Time frame: single point assessment in one day during walking with the probe
lower limb kinematics
Time frame: single point assessment in one day during walking without the probe
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 4 Jun 2024.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic ultrasound of the calf muscles in people with Stroke and Gait Disorders, Neurologic, run by University Hospital, Ghent 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 0 inclusion and 6 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 4 Jun 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?
Fascicle dynamics measured with ultrasound during walking (time frame: single point assessment in one day during walking with the probe). The study lists 3 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 4 Jun 2024.