Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors

• Conditions: Stroke; Spastic Foot

• Registration Number: NCT05097482
• Lead Sponsor: Alessio Baricich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-14
• Study First Submitted: 2021-08-31
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-10-28
• Last Update Posted: 2021-10-28
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Maggiore della Carità University Hospital; 🇮🇹 Novara, Italy