StrokeSpasticityNCT07156760
Morphological Characteristics of the Upper and Lower Extremities Using Ultrasound Examination After Stroke.
An observational study of Stroke, run by Universidad de La Frontera at 2 sites in Chile.
Trial summary
Introduction A large number of stroke patients develop spasticity in the upper and lower extremities, which is one of the clinical signs of damage to motor neuron 1, causing abnormal postures and movement patterns due to motor neuron hyperexcitability and rheological alterations in the affected muscles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Ultrasound diagnostics
- How many people
- 80 participants
- Where
- 2 sitesChile
- Study dates
- 1 Mar 2025to 31 Dec 2025
- How long will I take part?
- 24 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult stroke patients with spasticity.
Who may be able to join
- Patients over 18 years of age with a history of stroke more than three months ago.
- Who are undergoing or have undergone some type of rehabilitation in the acute and/or subacute stage.
- Who present spastic hypertonia in the upper and lower extremities detectable by Ashworth and Tardieu assessment.
- Presence of spastic pattern according to Hefter classification.
- Who agree to participate in the study and sign the consent form.
Who cannot join
- Structural joint involvement that prevents tone assessment.
- Patients who have been injected with antispastic drugs in the last 6 months.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Universidad de La Frontera
Temuco, Araucania, 4780000
Universidad de La Frontera
Temuco, 478000
About this study
Official title: Morphological Characteristics of Spastic Musculature in the Upper and Lower Extremities Using Ultrasound Examination in Subjects After Stroke
Introduction A large number of stroke patients develop spasticity in the upper and lower extremities, which is one of the clinical signs of damage to motor neuron 1, causing abnormal postures and movement patterns due to motor neuron hyperexcitability and rheological alterations in the affected muscles. These alterations limit the use of the arm and leg, restricting their use in functional activities and affecting the quality of life and social participation of users. In recent years, the Heckmann scale has been used to evaluate spastic muscle alterations by ultrasound; however, evidence is limited regarding its benefits as an assessment tool for spastic hypertonia.
Objective To describe the morphological characteristics of spastic muscles in the lower extremities using ultrasound examination in subjects after stroke.
Read more
Method A prospective, multicenter descriptive study will be conducted. The sample will be non-probabilistic, consisting of 80 subjects who meet the eligibility criteria and provide informed consent.
Analysis of results Using the SPSS 27 program, a descriptive analysis will be performed using statistical indices of central tendency, dispersion, and distribution according to the measurement scale of each variable. The normality of the distribution of continuous variables will be investigated. In addition, a bivariate correlation analysis (ANOVA) will be performed. The significance level will be 0.05.
Expected Results It will provide updated evidence in the field of assessing the state of spastic muscles in subjects with neurological damage, a situation that will guide the therapeutic process and may improve the patient's prognosis and quality of life.
Read the detailed description
Background: Spasticity is considered a positive clinical sign of upper motor neuron damage, associated with prevalent neurological pathologies such as stroke, constituting a clinical characteristic with a high incidence in the field of neurorehabilitation.
General Objective To describe the morphological characteristics of spastic biceps brachii and triceps surae muscles, using ultrasound examination, in subjects who have suffered a stroke.
Specific Objectives
- Identify the morphological characteristics of the biceps, using ultrasound examination, in subjects after stroke.
- Identify the morphological characteristics of the triceps surae, using ultrasound examination, in subjects after stroke.
- Correlate the morphological characteristics of the biceps and triceps surae with the values obtained on the Ashworth and Tardieu scales.
- Correlate the morphological characteristics of the biceps and triceps surae with the time of evolution and type of stroke.
Procedure
The first recruitment contact will be made by a professional from each participating center, who will inform the patient about the characteristics of the study and their future participation. Subsequently, eligibility criteria will be evaluated in order to identify 10 to 15 users per participating center.
After identification and signing of the consent form, participants will be invited to each center, where a professional will complete a structured clinical interview to obtain demographic and clinical data such as: type of stroke, time of onset, location, side affected, and treatments received.
Ultrasound evaluation Each participant will undergo a non-invasive ultrasound evaluation of the upper limb on the paralyzed side (using a portable Ekipomed ultrasound machine) to determine its pathological morphology (thickness, fiber orientation, and echogenicity) using the modified Heckmatt scale. This procedure will be performed by a physiatrist who is an expert in muscle ultrasound (with extensive experience and training in sonoanatomy). The technique involves placing the person in a supine or seated position, requesting that the biceps and triceps surae muscles be left free, then applying a colorless, hypoallergenic gel and proceeding with the examination by applying a transducer head to the gel located on the muscle to be evaluated. The procedure lasts 15 minutes per person.
nalysis All information will be compiled in an Excel database and statistically analyzed using SPSS 25 statistical software. The analysis will be descriptive, using statistical indices of central tendency, dispersion, and distribution according to the measurement scale of each variable. The normality of the distribution of continuous variables will be investigated. In addition, a bivariate correlation analysis will be performed using ANOVA. In all relevant analyses, the significance level will be 0.05.
Expected results Currently, advances in technology raise new questions and challenges. Given the above, this study will provide updated evidence in the field of neurorehabilitation assessment, associated with a pathology of high prevalence at the national and global level, such as stroke. This pathology manifests itself with clinical signs, including spastic hypertonia, a disorder that causes severe disability and affects people's quality of life. The results of this study will guide the therapeutic process, specifically in relation to the management of spastic hypertonia, a condition that can improve the patient's prognosis and promote a better quality of life and social interaction.
- Conditions
- Stroke
- Being tested
- Ultrasound diagnostics
- Keywords
- stroke, Spasticity Muscle, Ultrasound diagnostics
- 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 diagnosticsDiagnostic test
Non-invasive ultrasound evaluation of the upper limb on the hemiplegic side (Ekipomed Portable Ultrasound) to determine its pathological morphology (thickness, fiber orientation, and echogenicity) using the modified Heckmatt scale. This procedure will be performed by a physician who is an expert in muscle ultrasound.
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity
Modified Ashworth Scale (MAS) The scale measures resistance during passive soft-tissue stretching. Lower values mean less spasticity
Scoring:
0 - No increase in muscle tone.
1 - Slight increase in muscle tone, manifested by a catch and release at the end of the range of motion when the affected part(s) are moved in flexion or extension.
1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.
2 - More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved.
3 - Considerable increase in muscle tone, passive movement difficult. 4 - Affected part(s) rigid in flexion or extension.
Measured: Outcome measure: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.
Secondary outcomes (2)
Spasticity
Tardieu Scale (TS) Is a clinical tool used to assess spasticity by measuring the muscle's response to passive stretch at different velocities.
The examiner moves the limb passively at three different speeds:
V1: As slow as possible (to measure the full passive range of motion). V2: At the speed of the limb segment falling under gravity. V3: As fast as possible (faster than the natural drop of the limb under gravity).
Two key measures are recorded:
R1 (angle of catch): The angle at which a "catch" or resistance is first felt during a fast stretch.
R2 (full passive range of motion): The angle of full joint range measured at slow speed.
Interpretation:
A large difference between R1 and R2 indicates a significant dynamic (neural) component of spasticity.
A small difference suggests a greater fixed contracture or mechanical l
Measured: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.
Morphological characteristics
The Modified Heckmatt Scale (MHS) is a clinical ultrasound grading system used to evaluate muscle echogenicity and architecture, particularly in patients with neuromuscular disorders. It assesses the degree of increased echogenicity (brightness) and loss of normal bone-muscle contrast, which reflect changes such as fibrosis, fatty infiltration, or atrophy.
The scale typically ranges from Grade 1 (normal muscle: dark muscle with clear bone echo) to Grade 4 (severe abnormality: very bright muscle, bone echo poorly visible or lost).
Measured: Day 1, after the initial assessment. 5 patients per day, completing 15 per week at each center. Total intervention time, through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Mar 2025
- Primary completion1 Apr 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARLETTE PATRICIA DOUSSOULIN SANHUEZA, Universidad de La Frontera
- Investigators
- Arlette P. Doussoulin, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156760
- Sponsor's protocol ID
- DIUFRO FONDOS PROPIOS 240045
- Other IDs
- DIUFRO FONDOS PROPIOS 240045
- Acronym
- Spasticity
- Status last verified
- Apr 2026
- First submitted
- 10 Aug 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Doussoulin A, Rivas R, Sabelle C. [Hospital discharges due to stroke in the period 2001-2010 in a southern Chilean region]. Rev Med Chil. 2016 May;144(5):571-6. doi: 10.4067/S0034-98872016000500003. Spanish.
PubMed 27552006Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.
PubMed 25530960Li S. Spasticity, Motor Recovery, and Neural Plasticity after Stroke. Front Neurol. 2017 Apr 3;8:120. doi: 10.3389/fneur.2017.00120. eCollection 2017.
PubMed 28421032
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Characteristics of Spastic Musculature in the Upper and Lower Extremities Using Ultrasound Examination in Subjects After Stroke
- ClinicalTrials.gov ID
- NCT07156760
- Acronym / sponsor ID
- Spasticity / DIUFRO FONDOS PROPIOS 240045
- Conditions
- Stroke
- Keywords
- stroke, Spasticity Muscle, Ultrasound diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Sep 2025 (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.
Introduction A large number of stroke patients develop spasticity in the upper and lower extremities, which is one of the clinical signs of damage to motor neuron 1, causing abnormal postures and movement patterns due to motor neuron hyperexcitability and rheological alterations in the affected muscles. These alterations limit the use of the arm and leg, restricting their use in functional activities and affecting the quality of life and social participation of users. In recent years, the Heckmann scale has been used to evaluate spastic muscle alterations by ultrasound; however, evidence is limited regarding its benefits as an assessment tool for spastic hypertonia.
Objective To describe the morphological characteristics of spastic muscles in the lower extremities using ultrasound examination in subjects after stroke.
Method A prospective, multicenter descriptive study will be conducted. The sample will be non-probabilistic, consisting of 80 subjects who meet the eligibility criteria and provide informed consent.
Analysis of results Using the SPSS 27 program, a descriptive analysis will be performed using statistical indices of central tendency, dispersion, and distribution according to the measurement scale of each variable. The normality of the distribution of continuous variables will be investigated. In addition, a bivariate correlation analysis (ANOVA) will be performed. The significance level will be 0.05.
Expected Results It will provide updated evidence in the field of assessing the state of spastic muscles in subjects with neurological damage, a situation that will guide the therapeutic process and may improve the patient's prognosis and quality of life.
Detailed description
Background: Spasticity is considered a positive clinical sign of upper motor neuron damage, associated with prevalent neurological pathologies such as stroke, constituting a clinical characteristic with a high incidence in the field of neurorehabilitation.
General Objective To describe the morphological characteristics of spastic biceps brachii and triceps surae muscles, using ultrasound examination, in subjects who have suffered a stroke.
Specific Objectives
- Identify the morphological characteristics of the biceps, using ultrasound examination, in subjects after stroke.
- Identify the morphological characteristics of the triceps surae, using ultrasound examination, in subjects after stroke.
- Correlate the morphological characteristics of the biceps and triceps surae with the values obtained on the Ashworth and Tardieu scales.
- Correlate the morphological characteristics of the biceps and triceps surae with the time of evolution and type of stroke.
Procedure
The first recruitment contact will be made by a professional from each participating center, who will inform the patient about the characteristics of the study and their future participation. Subsequently, eligibility criteria will be evaluated in order to identify 10 to 15 users per participating center.
After identification and signing of the consent form, participants will be invited to each center, where a professional will complete a structured clinical interview to obtain demographic and clinical data such as: type of stroke, time of onset, location, side affected, and treatments received.
Ultrasound evaluation Each participant will undergo a non-invasive ultrasound evaluation of the upper limb on the paralyzed side (using a portable Ekipomed ultrasound machine) to determine its pathological morphology (thickness, fiber orientation, and echogenicity) using the modified Heckmatt scale. This procedure will be performed by a physiatrist who is an expert in muscle ultrasound (with extensive experience and training in sonoanatomy). The technique involves placing the person in a supine or seated position, requesting that the biceps and triceps surae muscles be left free, then applying a colorless, hypoallergenic gel and proceeding with the examination by applying a transducer head to the gel located on the muscle to be evaluated. The procedure lasts 15 minutes per person.
nalysis All information will be compiled in an Excel database and statistically analyzed using SPSS 25 statistical software. The analysis will be descriptive, using statistical indices of central tendency, dispersion, and distribution according to the measurement scale of each variable. The normality of the distribution of continuous variables will be investigated. In addition, a bivariate correlation analysis will be performed using ANOVA. In all relevant analyses, the significance level will be 0.05.
Expected results Currently, advances in technology raise new questions and challenges. Given the above, this study will provide updated evidence in the field of neurorehabilitation assessment, associated with a pathology of high prevalence at the national and global level, such as stroke. This pathology manifests itself with clinical signs, including spastic hypertonia, a disorder that causes severe disability and affects people's quality of life. The results of this study will guide the therapeutic process, specifically in relation to the management of spastic hypertonia, a condition that can improve the patient's prognosis and promote a better quality of life and social interaction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult stroke patients with spasticity.
Key inclusion criteria (5 listed)
- Patients over 18 years of age with a history of stroke more than three months ago.
- Who are undergoing or have undergone some type of rehabilitation in the acute and/or subacute stage.
- Who present spastic hypertonia in the upper and lower extremities detectable by Ashworth and Tardieu assessment.
- Presence of spastic pattern according to Hefter classification.
- Who agree to participate in the study and sign the consent form.
Key exclusion criteria (2 listed)
- Structural joint involvement that prevents tone assessment.
- Patients who have been injected with antispastic drugs in the last 6 months.
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 diagnosticsNon-invasive ultrasound evaluation of the upper limb on the hemiplegic side (Ekipomed Portable Ultrasound) to determine its pathological morphology (thickness, fiber orientation, and echogenicity) using the modified Heckmatt scale. This procedure will be performed by a physician who is an expert in muscle ultrasound. | Diagnostic test | – |
Primary outcome
Spasticity
Time frame: Outcome measure: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.
Modified Ashworth Scale (MAS) The scale measures resistance during passive soft-tissue stretching. Lower values mean less spasticity Scoring: 0 - No increase in muscle tone. 1 - Slight increase in muscle tone, manifested by a catch and release at the end of the range of motion when the affected part(s) are moved in flexion or extension. 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2 - More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved. 3 - Considerable increase in muscle tone, passive movement difficult. 4 - Affected part(s) rigid in flexion or extension.
2 secondary outcomes
Spasticity
Time frame: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.
Morphological characteristics
Time frame: Day 1, after the initial assessment. 5 patients per day, completing 15 per week at each center. Total intervention time, through study completion, an average of 6 months.
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 28 Apr 2026.
- Background: PubMed 27552006Doussoulin A, Rivas R, Sabelle C. [Hospital discharges due to stroke in the period 2001-2010 in a southern Chilean region]. Rev Med Chil. 2016 May;144(5):571-6. doi: 10.4067/S0034-98872016000500003. Spanish.
- Background: PubMed 25530960Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.
- Background: PubMed 28421032Li S. Spasticity, Motor Recovery, and Neural Plasticity after Stroke. Front Neurol. 2017 Apr 3;8:120. doi: 10.3389/fneur.2017.00120. eCollection 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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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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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.
Arlette P. Doussoulin, PhD principal investigator
Universidad de La Frontera
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Universidad de La Frontera at 2 sites in Chile.
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 2 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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?
Spasticity (time frame: Outcome measure: Day 1, prior to the ultrasound scan. The results report will be issued 1 month after the analysis, sharing the analysis with participating centers and patients. On average, 1 year after the start of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07156760, which also lists 3 linked publications.
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 28 Apr 2026.