StrokeUS-functionNCT06411587
Analysis of the Correlation Between Ultrasound Imaging and Functional Parameters in the Medial Gastrocnemius Muscle in Post-stroke Patients With Spasticity in the Lower Limb
An observational study of Stroke and Spasticity, Muscle, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
The goal of this observational study is to understand the impact of spasticity on muscle changes and functional performance in stroke patients with lower limb spasticity in comparison to non-stroke individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spasticity, Muscle
- What is being tested?
- Ultrasound imaging and functional assessment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 27 Feb 2024to 30 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke group: patients diagnosed with ischemic or hemorrhagic stroke who follow the selection criteria. Non-stroke group: patients without a diagnosis of stroke matching with each member of the stroke group.
Who may be able to join
- Age over 18 years
- Present spasticity in the plantar flexor muscles of the ankle as a result of a first unilateral ischemic or hemorrhagic stroke (excluding subarachnoid hemorrhage, as it is not truly a stroke) diagnosed by computed tomography or magnetic resonance imaging.
- Have more than 6 months of evolution since the onset of the cerebrovascular accident (chronic stroke).
- Degree of spasticity on the Modified Ashworth Scale (MAS): 1, 1+, 2, or 3.
- Be able to walk independently with or without assistance.
- Age over 18 years
- Be able to walk independently with or without assistance
Who cannot join
- Other musculoskeletal or neurological disorders affecting the lower limb (bilateral stroke, peripheral neuropathy, peripheral nerve injury, myopathy, severe osteoarthritis, recent muscle injury, recent bone fracture, joint replacement, fixed contractures involving the affected leg, bone deformities of the lower limbs).
- Other neurological pathologies (e.g., ataxia or dystonia).
- Surgical intervention in the lower limb.
- Cognitive impairments that hinder study measurements.
- Other medical conditions that may interfere with data interpretation.
- Group of non-stroke patients
Show all 13Show fewer
- Previous diagnosis of stroke.
- Presence of spasticity in any part of the body.
- Other musculoskeletal or neurological disorders affecting the lower limb (bilateral stroke, peripheral neuropathy, peripheral nerve injury, myopathy, severe osteoarthritis, recent muscle injury, recent bone fracture, joint replacement, fixed contractures involving the affected leg, bone deformities of the lower limbs).
- Other neurological pathologies (e.g., ataxia or dystonia).
- Surgical intervention in the lower limb.
- Cognitive impairments that hinder study measurements.
- Other medical conditions that may interfere with data interpretation.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to understand the impact of spasticity on muscle changes and functional performance in stroke patients with lower limb spasticity in comparison to non-stroke individuals. The main questions it aims to answer are:
- How does spasticity affect muscle changes and lower limb functional performance in stroke patients?
- How do structural and textural parameters in ultrasound images differ between spastic stroke patients and non-stroke individuals?
Read more
Participants will undergo ultrasound evaluation of their leg muscles to measure structural and textural parameters. They will also take part in functional assessments to assess their performance in activities related to lower limb mobility.
Researchers will compare the structural and textural ultrasound parameters between stroke patients and non-stroke individuals to determine any notable differences. The study aims to identify the relationship between muscle changes, spasticity, and functional performance in stroke patients.
Read the detailed description
Cerebrovascular Accident (CVA) or stroke is one of the leading causes of morbidity and disability worldwide. Spasticity is a common complication in patients with CVA, affecting between 43.2% and 49.5% of patients in the first six months. It can interfere with movement and cause discomfort, pain, joint contracture, and abnormal limb posture. Ankle spasticity is particularly problematic for gait recovery.
Computed tomography (CT) and magnetic resonance imaging (MRI) are considered the gold standard for measuring muscle mass, but their use is not practical due to patient discomfort, radiation exposure, and high costs. Ultrasound is presented as an effective and low-cost tool for evaluating muscle tissues.
Previous research has analyzed architectural changes in spastic muscles in hemiplegic patients and found conflicting results regarding muscle thickness and fascicle length. Further studies are needed to better understand the relationship between muscle changes and weakness, spasticity, and functional performance of the lower limbs.
This study aims to analyze the relationship between muscular architecture and echotexture parameters, and the functional parameters of the medial gastrocnemius muscle in patients with spasticity in the lower limb after a stroke and compare them with non-stroke subjects.
Comparing the affected side with the supposedly healthy side of stroke patients will allow for a better understanding of the structural changes that occur on both sides.
Studying structural changes in patients with chronic spasticity after a stroke can help healthcare professionals better understand the impact of this condition on muscle function and develop personalized treatment plans. Ultrasound can be a useful tool to improve the effectiveness of rehabilitation interventions in stroke survivors.
- Conditions
- Stroke, Spasticity, Muscle
- Being tested
- Ultrasound imaging and functional assessment
- Keywords
- Stroke, Ultrasound imaging, Spasticity, muscle, Function
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imaging and functional assessmentDiagnostic test
Participants in this study will undergo two types of assessments: capturing muscle images using ultrasound and evaluating their function through clinical scales.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stroke | Patients with a chronic stroke and spasticity in the ankle flexors muscles. Receives: Diagnostic Test: Ultrasound imaging and functional assessment | |
| Patients without stroke | Patients without stroke were matched with those with stroke based on age and sex. Receives: Diagnostic Test: Ultrasound imaging and functional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
It is the distance between the superficial and deep layer of the fascia of the medial gastrocnemius. It is considered one of the 3 muscular architecture parameters that will be measured using ultrasound images collected with the Butterfly iQ+ portable device by Butterfly Network, Inc., a company located in the United Kingdom. The device is connected to a tablet from which the images are visualized and captured. For more information about the device, you can visit the following link: www.butterflynetwork.com/int/es-es/individual
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Fascicle length
It is the estimation of the length of the muscle fiber, which is obtained by tracing a line that covers the length of the muscle fascicle between the deep and superficial aponeuroses.
Measured: Through study completion, an average of 1 year
Pennation angle
It is the angle between the deep fascia and the line of the fascicle length.
Measured: Through study completion, an average of 1 year
Concurrence matrices
Measures that describe the spatial distribution of gray levels in the texture of an ultrasound image. These matrices, also known as co-occurrence matrices, are used to analyze textural features and patterns in ultrasound images.
Measured: Through study completion, an average of 1 year
Degree of spasticity
It will be measured using the Modified Ashworth Scale (MAS). The scale ranges from a minimum value of 0 to a maximum of 4, with 0 indicating no spasticity and 4 representing the most severe spasticity, characterized by complete rigidity.
Measured: Through study completion, an average of 1 year
Functional capacity
Measured by Time Up and Go (TUG)
Measured: Through study completion, an average of 1 year
Functional capacity
Measured by 10 Meter Walk Test (10MWT)
Measured: Through study completion, an average of 1 year
Muscle strength
Maximum isometric contractions will be measured using dynamometry.
Measured: Through study completion, an average of 1 year
Contraction velocity, relaxation velocity, and shrinkage potential
The Movement mode will be used to calculate these parameters simultaneously taken the force using dynamometry. This will allow correlating the Modo M with force.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start27 Feb 2024
- Primary completion1 Dec 2024
- Study completion30 Dec 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.
- 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
- Other
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pablo Herrero Gallego, Universidad de Zaragoza
- Investigators
- Pablo Herrero Gallego, Physical Therapist, Study director, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411587
- Sponsor's protocol ID
- US-function
- Acronym
- US-function
- Status last verified
- Apr 2025
- First submitted
- 8 Mar 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The team is still figure it out what is the best way to share the information.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Correlation Between Ultrasound Imaging and Functional Parameters in the Medial Gastrocnemius Muscle in Post-stroke Patients With Spasticity in the Lower Limb
- ClinicalTrials.gov ID
- NCT06411587
- Acronym / sponsor ID
- US-function / US-function
- Conditions
- Stroke, Spasticity, Muscle
- Keywords
- Stroke, Ultrasound imaging, Spasticity, muscle, Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 May 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.
The goal of this observational study is to understand the impact of spasticity on muscle changes and functional performance in stroke patients with lower limb spasticity in comparison to non-stroke individuals. The main questions it aims to answer are:
- How does spasticity affect muscle changes and lower limb functional performance in stroke patients?
- How do structural and textural parameters in ultrasound images differ between spastic stroke patients and non-stroke individuals?
Participants will undergo ultrasound evaluation of their leg muscles to measure structural and textural parameters. They will also take part in functional assessments to assess their performance in activities related to lower limb mobility.
Researchers will compare the structural and textural ultrasound parameters between stroke patients and non-stroke individuals to determine any notable differences. The study aims to identify the relationship between muscle changes, spasticity, and functional performance in stroke patients.
Detailed description
Cerebrovascular Accident (CVA) or stroke is one of the leading causes of morbidity and disability worldwide. Spasticity is a common complication in patients with CVA, affecting between 43.2% and 49.5% of patients in the first six months. It can interfere with movement and cause discomfort, pain, joint contracture, and abnormal limb posture. Ankle spasticity is particularly problematic for gait recovery.
Computed tomography (CT) and magnetic resonance imaging (MRI) are considered the gold standard for measuring muscle mass, but their use is not practical due to patient discomfort, radiation exposure, and high costs. Ultrasound is presented as an effective and low-cost tool for evaluating muscle tissues.
Previous research has analyzed architectural changes in spastic muscles in hemiplegic patients and found conflicting results regarding muscle thickness and fascicle length. Further studies are needed to better understand the relationship between muscle changes and weakness, spasticity, and functional performance of the lower limbs.
This study aims to analyze the relationship between muscular architecture and echotexture parameters, and the functional parameters of the medial gastrocnemius muscle in patients with spasticity in the lower limb after a stroke and compare them with non-stroke subjects.
Comparing the affected side with the supposedly healthy side of stroke patients will allow for a better understanding of the structural changes that occur on both sides.
Studying structural changes in patients with chronic spasticity after a stroke can help healthcare professionals better understand the impact of this condition on muscle function and develop personalized treatment plans. Ultrasound can be a useful tool to improve the effectiveness of rehabilitation interventions in stroke survivors.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke | – | Diagnostic Test: Ultrasound imaging and functional assessmentPatients with a chronic stroke and spasticity in the ankle flexors muscles. |
| Patients without stroke | – | Diagnostic Test: Ultrasound imaging and functional assessmentPatients without stroke were matched with those with stroke based on age and sex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke group: patients diagnosed with ischemic or hemorrhagic stroke who follow the selection criteria. Non-stroke group: patients without a diagnosis of stroke matching with each member of the stroke group.
Key inclusion criteria (7 listed)
- Age over 18 years
- Present spasticity in the plantar flexor muscles of the ankle as a result of a first unilateral ischemic or hemorrhagic stroke (excluding subarachnoid hemorrhage, as it is not truly a stroke) diagnosed by computed tomography or magnetic resonance imaging.
- Have more than 6 months of evolution since the onset of the cerebrovascular accident (chronic stroke).
- Degree of spasticity on the Modified Ashworth Scale (MAS): 1, 1+, 2, or 3.
- Be able to walk independently with or without assistance.
Key exclusion criteria (13 listed)
- Other musculoskeletal or neurological disorders affecting the lower limb (bilateral stroke, peripheral neuropathy, peripheral nerve injury, myopathy, severe osteoarthritis, recent muscle injury, recent bone fracture, joint replacement, fixed contractures involving the affected leg, bone deformities of the lower limbs).
- Other neurological pathologies (e.g., ataxia or dystonia).
- Surgical intervention in the lower limb.
- Cognitive impairments that hinder study measurements.
- Other medical conditions that may interfere with data interpretation.
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 |
|---|---|---|
| Ultrasound imaging and functional assessmentParticipants in this study will undergo two types of assessments: capturing muscle images using ultrasound and evaluating their function through clinical scales. | Diagnostic test | Patients with stroke, Patients without stroke |
Primary outcome
Muscle thickness
Time frame: Through study completion, an average of 1 year
It is the distance between the superficial and deep layer of the fascia of the medial gastrocnemius. It is considered one of the 3 muscular architecture parameters that will be measured using ultrasound images collected with the Butterfly iQ+ portable device by Butterfly Network, Inc., a company located in the United Kingdom. The device is connected to a tablet from which the images are visualized and captured. For more information about the device, you can visit the following link: www.butterflynetwork.com/int/es-es/individual
8 secondary outcomes
Fascicle length
Time frame: Through study completion, an average of 1 year
Pennation angle
Time frame: Through study completion, an average of 1 year
Concurrence matrices
Time frame: Through study completion, an average of 1 year
Degree of spasticity
Time frame: Through study completion, an average of 1 year
Functional capacity
Time frame: Through study completion, an average of 1 year
Functional capacity
Time frame: Through study completion, an average of 1 year
Muscle strength
Time frame: Through study completion, an average of 1 year
Contraction velocity, relaxation velocity, and shrinkage potential
Time frame: Through study completion, an average of 1 year
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 22 May 2025.
- Individual participant dataSharing planned: Undecided. The team is still figure it out what is the best way to share the information.
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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.
Pablo Herrero Gallego, Physical Therapist study director
Universidad de Zaragoza
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 Stroke and Spasticity, Muscle, run by Universidad de Zaragoza at 1 site in Spain.
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 7 inclusion and 13 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 22 May 2025. 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 Spain. 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 thickness (time frame: Through study completion, an average of 1 year). 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 22 May 2025.