Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors
TriUS
Triceps Surae Muscle Characteristics in Hemiparetic Stroke Survivors: Clinical Implications From Ultrasonographic Evaluation
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2021
CompletedFirst Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedOctober 28, 2021
October 1, 2021
11 months
August 31, 2021
October 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Eligibility Criteria
Subjects already treated for focal post-stroke spasticity in our Unit
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alessio Baricichlead
Study Sites (1)
Maggiore della Carità University Hospital
Novara, 28100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor in Physical and Rehabilitation Medicine
Study Record Dates
First Submitted
August 31, 2021
First Posted
October 28, 2021
Study Start
January 14, 2021
Primary Completion
December 13, 2021
Study Completion
December 13, 2021
Last Updated
October 28, 2021
Record last verified: 2021-10