Viewing Study NCT06456333



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06456333
Status: COMPLETED
Last Update Posted: 2024-07-03
First Post: 2024-06-07

Brief Title: Exploring Paraspinal Electromyographic Features in Adolescent Idiopathic Scoliosis Patients
Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Organization: The First Affiliated Hospital of Zhejiang Chinese Medical University

Study Overview

Official Title: Paravertebral Electromyographic Characteristics of Adolescent Idiopathic Scoliosis Patients Explored on the Basis of High-density Surface Electromyography
Status: COMPLETED
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: None
Brief Summary: Adolescent Idiopathic Scoliosis AIS is a complex three-dimensional spinal deformity with onset in adolescents between the ages of 10 and 18 years characterized by coronal curvature sagittal imbalance and horizontal rotation of the spine The incidence of AIS is 1-4 globally with more females than males and it is a common frequent and difficult-to-treat disease that seriously jeopardizes the physical and mental health of adolescents

Previous studies have found significant changes in the morphologic structure and physiologic characteristics of the paraspinal muscles in patients with AIS including muscle fiber distribution muscle contraction and relaxation capacity the convex side of the AIS curve exhibits a higher level of electromyographic activity and asymmetric changes in the paraspinal muscles are highly correlated with progression of scoliosis The current single-electrode sEMG technique extracts limited muscle activity signals and is susceptible to interference from random noise Compared with the single-electrode sEMG technique HD-sEMG can provide rich spatiotemporal information on paraspinal muscle activity so it is necessary to use a wide and closely spaced electrode array for signal acquisition to obtain more accurate and detailed characteristics of paraspinal muscle activity

In summary this study used high-density surface electromyography to collect muscle parameters of the paraspinal muscles on the concave and convex sides of AIS patients and compared them with those of healthy people to comprehensively summarize the characteristics of their paraspinal muscles so as to provide scientific basis for the subsequent development of precise treatment plans and improvement of clinical efficacy
Detailed Description: Paravertebral muscle EMG signals were acquired from AIS patients and healthy controls under the BST test paradigm

Acquisition site paravertebral muscle at the L1-L3 level with the electrode sheet placed 15 cm adjacent to the spinous process

Biering-Sorensen testBSTThe subject was lying prone on the bed with the upper half of the body poking out of the bed the anterior superior iliac spine located at the edge of the bed both lower limbs partially immobilized on the bed with straps both hands crossed in front of the chest grasping the contralateral shoulder and tightly pressed against the chest wall and the torso was suspended in the air and parallel to the floor and the patient stopped the test when heshe maintained this position for 90s

Observation indicators

1 the average change mean characteristics of each channel signal including the 32 channels of the root mean square value RMS mean power frequncyMPF fractal dimensionFDSlope sign changeSSC a total of 4 types of indicators-reflecting the strength and fatigue of muscle contractions

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