Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors

Triceps Surae Muscle Characteristics in Hemiparetic Stroke Survivors: Clinical Implications From Ultrasonographic Evaluation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05097482

Acronym

TriUS

Enrollment

Registered

2021-10-28

Start date

2021-01-14

Completion date

2021-12-13

Last updated

2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Foot, Stroke

Keywords

post-stroke spasticity, muscle, ultrasound

Brief 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 muscle echogenicity, the variations in the pennation angle, and the length of the fascicles. For image processing operations, ImageJ software was applied.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
muscle structure variations	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.

Countries

Italy

Contacts

Primary ContactAlessio Baricich, MD PhD

alessio.baricich@med.uniupo.it03213734844

Outcome results