- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07804836
Investigation of Muscle Activity With sEMG, Surface Topography and Radiographic Changes of Paraspinal Muscles in Individuals With Adolescent Idiopathic Scoliosis.
Investigation of Muscle Activity, Surface Topography and Radiographic Changes of Paraspinal Muscles in Individuals With Adolescent Idiopathic Scoliosis.
Study Overview
Status
Conditions
Detailed Description
This study was designed to examine paraspinal muscle activity, surface topography, and radiographic characteristics in adolescents with idiopathic scoliosis. The study plans to include adolescents aged 10-18 years diagnosed with idiopathic scoliosis, as well as healthy volunteers matched for age and gender.
Participants will be divided into three groups: adolescents with idiopathic scoliosis who wear a brace, adolescents with idiopathic scoliosis who do not wear a brace, and a healthy control group. A total of 45 participants are planned to be included in the study, with 15 participants in each group.
As part of the study, participants' demographic information will be recorded. Muscle activity in the paraspinal muscles will be assessed using surface electromyography (sEMG). Body surface topography will be assessed using an Artec Eva 3D scanner. Posture analysis will be performed, and spinal curvature will be assessed using the Cobb angle based on existing radiographic images. Quality of life will be determined using the Scoliosis Research Society-22 (SRS-22) questionnaire.
The measurement results obtained will be compared across groups, and the relationships between muscle activity, surface topography, postural characteristics, radiographic parameters, and quality of life will be evaluated.
As part of this study, participants will not receive any treatment or rehabilitation interventions; measurements will be taken to assess their current clinical and physical characteristics.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- Be between the ages of 10 and 18
- Have been diagnosed with adolescent idiopathic scoliosis
- Be able to stand independently
- Sign the informed consent form
- Have no spinal deformity (for the control group)
- History of neurological disease
- History of spinal surgery
- Presence of congenital or traumatic scoliosis
- Presence of orthopedic or rheumatological conditions that could affect the measurements
- Inability to cooperate during the measurements
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Study Participants
The study participants include adolescents with adolescent idiopathic scoliosis, including individuals who use a brace and those who do not use a brace, as well as healthy control individuals who meet the eligibility criteria.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Paraspinal Muscle Activity
Time Frame: Baseline (single assesment)
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Paraspinal muscle activity will be assessed using surfaces electromyography (sEMG) in adolescents with adolescent idiopathic scoliosis and healthy controls.
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Baseline (single assesment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surface Topography
Time Frame: Baseline (single assesment)
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Surface topography will be assessed to evaluate trunk surface characteristics in adolescents with adolescent idiopathic scoliosis and healthy controls.
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Baseline (single assesment)
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Radiographic Parameters
Time Frame: Baseline (single assesment)
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Radiographic parameters will be evaluated to assess spinal alignment in adolescents with adolescent idiopathic scoliosis.
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Baseline (single assesment)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Paraspinal muscles for AIS
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