Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors (TriUS)

October 24, 2021 updated by: Alessio Baricich

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects already treated for focal post-stroke spasticity in our Unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
single measure through study completion (1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alessio Baricich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2021

Primary Completion (Anticipated)

December 13, 2021

Study Completion (Anticipated)

December 13, 2021

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TriUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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