Spastic FootTriUSNCT05097482
Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors
An observational study of Spastic Foot and Stroke, run by Alessio Baricich at 1 site in Italy.
Trial summary
This study aims to evaluate, in hemiparetic patients, changes in muscle ultrasound structure about the focal treatment of spasticity with botulinum toxin type A. For this purpose, the analysis of the mean echo intensity will be carried out on ultrasound acquisitions, identifying the possible correlations between the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spastic Foot, Stroke
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jan 2021to 13 Dec 2021
- 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
- Adult, Older adult
Study population: Subjects already treated for focal post-stroke spasticity in our Unit
Who may be able to join
- unilateral ischaemic or haemorrhagic stroke (documented with clinical examination and neuroradiological findings)
- presence of spasticity at lower limb muscles, at least grade 1+ in the modified Ashworth Scale 3.
- age ≥ 18 years
Who cannot join
- inability to walk before stroke
- presence of severe cognitive impairment
- presence of other musculoskeletal, neurological or cardiopulmonary impairment which can interfere with clinical findings
- presence of skin lesions that can contraindicate BoNT-A treatment
- previous surgical myotendinous elongation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Maggiore della Carità University Hospital
Novara, 28100
Alessio Baricich, 03213734844, alessio.baricich@maggioreosp.novara.it
About this study
Official title: Triceps Surae Muscle Characteristics in Hemiparetic Stroke Survivors: Clinical Implications From Ultrasonographic Evaluation
This study aims to evaluate, in hemiparetic patients, changes in muscle ultrasound structure about the focal treatment of spasticity with botulinum toxin type A. For this purpose, the analysis of the mean echo intensity will be carried out on ultrasound acquisitions, identifying the possible correlations between the muscle echogenicity, the variations in the pennation angle, and the length of the fascicles.
For image processing operations, ImageJ software was applied.
- Conditions
- Spastic Foot, Stroke
- Keywords
- post-stroke spasticity, muscle, ultrasound
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle structure variations
The primary outcome consists in detecting muscle structure variations during the procedure.
This measure will be related to the time frame between the first inoculation and the moment of image acquisition, and to the number of therapeutic cycles performed. The aim is to determine the potential correlation between BoNT-A injection and muscle structure evolution.
The time point of assessment is not pre-defined but the time since stroke onset and, if applicable, from the first BoNT-A injection will be recorded.
Each participant will be assessed once during the overall duration of the study.
Measured: single measure through study completion (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start14 Jan 2021
- Primary completion13 Dec 2021 (estimated)
- Study completion13 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic FootStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alessio Baricich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alessio Baricich, Università degli Studi del Piemonte Orientale Amedeo Avogadro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097482
- Sponsor's protocol ID
- TriUS
- Acronym
- TriUS
- Status last verified
- Oct 2021
- First submitted
- 31 Aug 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triceps Surae Muscle Characteristics in Hemiparetic Stroke Survivors: Clinical Implications From Ultrasonographic Evaluation
- ClinicalTrials.gov ID
- NCT05097482
- Acronym / sponsor ID
- TriUS / TriUS
- Conditions
- Spastic Foot, Stroke
- Keywords
- post-stroke spasticity, muscle, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alessio BaricichUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 13 Dec 2021 (estimated)
- Study completion
- 13 Dec 2021 (estimated)
- First posted
- 28 Oct 2021 (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.
This study aims to evaluate, in hemiparetic patients, changes in muscle ultrasound structure about the focal treatment of spasticity with botulinum toxin type A. For this purpose, the analysis of the mean echo intensity will be carried out on ultrasound acquisitions, identifying the possible correlations between the muscle echogenicity, the variations in the pennation angle, and the length of the fascicles.
For image processing operations, ImageJ software was applied.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects already treated for focal post-stroke spasticity in our Unit
Key inclusion criteria (3 listed)
- unilateral ischaemic or haemorrhagic stroke (documented with clinical examination and neuroradiological findings)
- presence of spasticity at lower limb muscles, at least grade 1+ in the modified Ashworth Scale 3.
- age ≥ 18 years
Key exclusion criteria (5 listed)
- inability to walk before stroke
- presence of severe cognitive impairment
- presence of other musculoskeletal, neurological or cardiopulmonary impairment which can interfere with clinical findings
- presence of skin lesions that can contraindicate BoNT-A treatment
- previous surgical myotendinous elongation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
muscle structure variations
Time frame: single measure through study completion (1 year)
The primary outcome consists in detecting muscle structure variations during the procedure. This measure will be related to the time frame between the first inoculation and the moment of image acquisition, and to the number of therapeutic cycles performed. The aim is to determine the potential correlation between BoNT-A injection and muscle structure evolution. The time point of assessment is not pre-defined but the time since stroke onset and, if applicable, from the first BoNT-A injection will be recorded. Each participant will be assessed once during the overall duration of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
Related trials for Spastic Foot
Active, not recruiting
Efficacy of Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot: A Randomized Clinical Trial
Post-Stroke Spasticity, Spastic Equinovarus Foot
Recruiting
To Evaluate the Efficiency and Results of Adding BFR to the Physical Therapy Program fo Managing Adolescents Presented With Spasmotic Flatfoot Deformities Compared to the Standard Physical Therapy Program Without BFR
Flat Foot; Spastic
Recruiting
Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach
Post Stroke Seizure, Spastic Foot
RecruitingObservational study
A Prospective Cohort Study of Surgical Treatment for Foot Deformities in HSP
Hereditary Spastic Paraplegia
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.
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 Spastic Foot and Stroke, run by Alessio Baricich at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Oct 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessio Baricich, MD PhD (03213734844, alessio.baricich@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle structure variations (time frame: single measure through study completion (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 28 Oct 2021.