Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors

Stroke Clinical Trial

— TriUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097482
• Other study ID #: TriUS
• Status: Recruiting
• Start date: January 14, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: October 2021
• Source: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Contact: Alessio Baricich, MD PhD
• Phone: 03213734844
• Email: alessio.baricich[@]med.uniupo.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 muscle echogenicity, the variations in the pennation angle, and the length of the fascicles.

For image processing operations, ImageJ software was applied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spastic Foot
• Stroke

Locations

Country	Name	City	State
Italy	Maggiore della Carità University Hospital	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Alessio Baricich

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	single measure through study completion (1 year)