Viewing Study NCT06411587



Ignite Creation Date: 2024-05-19 @ 5:33 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06411587
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-06-11
First Post: 2024-03-08

Brief Title: Analysis of the Correlation Between Ultrasound Imaging and Functional Parameters in the Medial Gastrocnemius Muscle in Post-stroke Patients With Spasticity in the Lower Limb
Sponsor: Universidad de Zaragoza
Organization: Universidad de Zaragoza

Study Overview

Official Title: Analysis of the Correlation Between Ultrasound Imaging and Functional Parameters in the Medial Gastrocnemius Muscle in Post-stroke Patients With Spasticity in the Lower Limb
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: US-function
Brief Summary: The goal of this observational study is to understand the impact of spasticity on muscle changes and functional performance in stroke patients with lower limb spasticity in comparison to non-stroke individuals The main questions it aims to answer are

How does spasticity affect muscle changes and lower limb functional performance in stroke patients
How do structural and textural parameters in ultrasound images differ between spastic stroke patients and non-stroke individuals

Participants will undergo ultrasound evaluation of their leg muscles to measure structural and textural parameters They will also take part in functional assessments to assess their performance in activities related to lower limb mobility

Researchers will compare the structural and textural ultrasound parameters between stroke patients and non-stroke individuals to determine any notable differences The study aims to identify the relationship between muscle changes spasticity and functional performance in stroke patients
Detailed Description: Cerebrovascular Accident CVA or stroke is one of the leading causes of morbidity and disability worldwide Spasticity is a common complication in patients with CVA affecting between 432 and 495 of patients in the first six months It can interfere with movement and cause discomfort pain joint contracture and abnormal limb posture Ankle spasticity is particularly problematic for gait recovery

Computed tomography CT and magnetic resonance imaging MRI are considered the gold standard for measuring muscle mass but their use is not practical due to patient discomfort radiation exposure and high costs Ultrasound is presented as an effective and low-cost tool for evaluating muscle tissues

Previous research has analyzed architectural changes in spastic muscles in hemiplegic patients and found conflicting results regarding muscle thickness and fascicle length Further studies are needed to better understand the relationship between muscle changes and weakness spasticity and functional performance of the lower limbs

This study aims to analyze the relationship between muscular architecture and echotexture parameters and the functional parameters of the medial gastrocnemius muscle in patients with spasticity in the lower limb after a stroke and compare them with non-stroke subjects

Comparing the affected side with the supposedly healthy side of stroke patients will allow for a better understanding of the structural changes that occur on both sides

Studying structural changes in patients with chronic spasticity after a stroke can help healthcare professionals better understand the impact of this condition on muscle function and develop personalized treatment plans Ultrasound can be a useful tool to improve the effectiveness of rehabilitation interventions in stroke survivors

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None